Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

category

rct

is Randomized Controlled Trial

true

basis

Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

sources

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

review Scope

full-text

scope

Paper

status

assessed

score

2

randomized Controlled Trial

true

peer Reviewed

true

blinding

not-confirmed

basis

Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

sources

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

review Scope

full-text

human Approval

false

display Crosses

2

masking Roles

participants

Explicitly unmasked.

providers

Explicitly unmasked.

assessors

Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

analysts

Not established from accessed source.

rating Scale

library-trust-factor/1-3

status

unassessed

score

Not recorded

evidence Type

Cluster randomized feasibility trial with recruitment after cluster allocation

intervention

Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women. One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

comparator

Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

sample

43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

measurement

Psychological distress: depression, anxiety, PTSD; Psychological, physical and sexual IPV frequency; Functional impairment; Exploratory high-baseline-IPV subgroup; PTSD among intervention completers

timing

Nine weeks after enrollment, approximately one week after intervention; Nine weeks

trial Id

ISRCTN65771265

relationship Note

Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope. See limitation and quality fields; no population-wide clinical recommendation is implied.

measured Genes

None recorded

pathways

None recorded

source Access

level

full-text

source URLs

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

retrieved At

2026-10-30T08:21:33.147602+00:00

outcomes

1. name

   Psychological distress: depression, anxiety, PTSD

   follow Up

   Nine weeks after enrollment, approximately one week after intervention

   result

   Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

   effect Estimate

   Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

   uncertainty

   Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

   primary Status

   primary

2. name

   Psychological, physical and sexual IPV frequency

   follow Up

   Nine weeks

   result

   No clear comparative benefit after baseline adjustment.

   effect Estimate

   Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

   uncertainty

   Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

   primary Status

   primary

3. name

   Functional impairment

   follow Up

   Nine weeks

   result

   No clear comparative difference.

   effect Estimate

   Adjusted MD−0.14 (95% CI−0.37, 0.09).

   uncertainty

   Model 3 n 272.

   primary Status

   secondary

4. name

   Exploratory high-baseline-IPV subgroup

   follow Up

   Nine weeks

   result

   Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

   effect Estimate

   Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

   uncertainty

   Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

   primary Status

   exploratory

5. name

   PTSD among intervention completers

   follow Up

   Nine weeks

   result

   Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

   effect Estimate

   MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

   uncertainty

   Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

   primary Status

   exploratory per-protocol

quality

risk Of Bias

Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

attrition

36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

confounding

Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

adverse Findings

Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

transfer Limits

Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

jadad

not established

masking Roles

participants

Explicitly unmasked.

providers

Explicitly unmasked.

assessors

Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

analysts

Not established from accessed source.

population

relation

direct

population

Congolese refugee women with past-year IPV and elevated psychological distress.

exposure Evidence

Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

rationale

Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

transfer Limit

See limitation and quality fields; no population-wide clinical recommendation is implied.

count

Not recorded

source

Not recorded

retrieved At

Not recorded

status

not-assessed

language

Not recorded

status

approved-for-publication

approved By

Ben Korbel

approved At

2026-11-01

assessment

AI assessed; human approved for publication

scope

Qualified research-library summaries. No professional clinical peer review or treatment recommendation is claimed.

source Revision

audit-r2-33df2f11c37a

source Content Hash

33df2f11c37ac48d21836ade531c0e6186b61eb20da2a91e477eebb3748f1093

level

full-text

source URLs

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

retrieved At

2026-10-30T08:21:33.147602+00:00

auditor

Codex (AI)

completed At

2026-10-31T05:11:05.655793+00:00

prior Content Hash

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prior Revision

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prior Source

frozen-120

source Verification

id

dv-adult-therapy-34143803

doi

10.1371/journal.pone.0252982

pmid

34143803

fresh Metadata

Europe PMC core

metadata Retrieved

true

metadata SHA256

abbdeeb3a4c53df1872ebdffa257b3603c7ce2c2a3a80a11e383ee2d9e34369d

claim Check

Headline finding/design/limitations compared with indexed abstract or accessible primary evidence; retained methods amendments separately adjudicated.

sources

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

applied Proposals

methods-adult/proposed-candidates.json

method

AI editorial assessment of all 130 publication records: compare identity, headline finding, design, relevance and limitations with indexed abstracts or available primary material; adjudicate retained source-supported methods amendments. This is a source-limited publication audit, not an independent full-text systematic review or a clinical guideline.

limitations

Abstract-only records do not establish allocation concealment, complete harms reporting or full risk of bias. · No formal independent RoB 2, GRADE appraisal or numerical reconstruction of every effect was performed. · Source-access labels describe retained appraisal evidence; fuller prior appraisals were checked through their source ledgers and selected material, not independently repeated in full. · Publication counts are not independent trial or participant counts; cohort links and overlapping review evidence remain provisional. · A randomized design cross does not indicate benefit, low risk of bias or human approval. No double-blind trial is verified in this release. · No professional clinical peer review is claimed. Recommended content is limited to accurately qualified research summaries.

https://doi.org/10.1371/journal.pone.0252982 · https://pubmed.ncbi.nlm.nih.gov/34143803/ · https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

language

Clinical & self-report · Methods & context

count

Not recorded

source

Not recorded

retrieved At

Not recorded

status

not-assessed

category

rct

is Randomized Controlled Trial

true

basis

Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

sources

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

review Scope

full-text

scope

Paper

status

assessed

score

2

randomized Controlled Trial

true

peer Reviewed

true

blinding

not-confirmed

basis

Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

sources

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

review Scope

full-text

human Approval

false

display Crosses

2

masking Roles

participants

Explicitly unmasked.

providers

Explicitly unmasked.

assessors

Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

analysts

Not established from accessed source.

rating Scale

library-trust-factor/1-3

language

Not recorded

1. key

   language:mindfulness-biofeedback

   title

   Mindfulness Biofeedback / AR / VR / Mixed Reality

   collection

   language

   trust Score

   2

2. key

   language:domestic-family-violence

   title

   Domestic & Family Violence

   collection

   language

   trust Score

   2

1. title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   journal

   PloS one

   year

   2021

   authors

   Greene MC; Likindikoki S; Rees S; Bonz A; Kaysen D; Misinzo L; Njau T; Kiluwa S; Turner R; Ventevogel P; Mbwambo JKK; Tol WA

   design

   Cluster randomized feasibility trial with recruitment after cluster allocation

   urls

   https://doi.org/10.1371/journal.pone.0252982 · https://pubmed.ncbi.nlm.nih.gov/34143803/ · https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   targets

   None recorded

   categories

   Clinical & self-report · Methods & context

   citation Count

   Not recorded

   evidence

   evidence Type

   Cluster randomized feasibility trial with recruitment after cluster allocation

   intervention

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women. One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   sample

   43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

   measurement

   Psychological distress: depression, anxiety, PTSD; Psychological, physical and sexual IPV frequency; Functional impairment; Exploratory high-baseline-IPV subgroup; PTSD among intervention completers

   timing

   Nine weeks after enrollment, approximately one week after intervention; Nine weeks

   trial Id

   ISRCTN65771265

   relationship Note

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope. See limitation and quality fields; no population-wide clinical recommendation is implied.

   measured Genes

   None recorded

   pathways

   None recorded

   source Access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   quality

   risk Of Bias

   Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

   attrition

   36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

   confounding

   Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

   adverse Findings

   Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

   transfer Limits

   Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

   jadad

   not established

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   population

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   id

   language-biofeedback-a21

   record Id

   dv-adult-therapy-34143803

   summary

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   limitation

   Under-recruitment, baseline imbalances, recruitment after cluster assignment, unmasked self-report, vulnerable assessor masking, complete-case analysis and severity-related intervention dropout limit causal inference. Table 1 reverses the narrative cluster-arm counts; all 43 clusters and individual 158/153 totals are retained.

   quotes

   None recorded

   source Pages

   None recorded

   paper Trust Assessment

   scope

   Paper

   status

   assessed

   score

   2

   randomized Controlled Trial

   true

   peer Reviewed

   true

   blinding

   not-confirmed

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   human Approval

   false

   display Crosses

   2

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   rating Scale

   library-trust-factor/1-3

   study Design Assessment

   category

   rct

   is Randomized Controlled Trial

   true

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   aliases

   None recorded

   collections

   language

   neurotransmitters

   None recorded

   conditions

   anxiety · ptsd · depression

   condition Evidence

   1. id

      anxiety

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         anxiety

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   2. id

      ptsd

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         PTSD

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   3. id

      depression

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         depression

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   age Groups

   adults

   age Population

   record Id

   dv-adult-therapy-34143803

   collections

   language

   groups

   adults

   reported Ages

   Eligibility 18+; sample mean 33.52 (SD 9.01) years. Observed minimum/maximum not established.

   youth Scope

   Not recorded

   youth Source Note

   No under 18 eligibility; no adolescent subgroup inference.

   source URL

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core

   basis Type

   source-limited-ai-editorial-assessment

   classification Note

   Original age terms: adults. Programme targets or possible eligibility are not counted as observed ages.

   community Matches

   1. category Id

      domestic-violence

      relation

      direct

   2. category Id

      refugees

      relation

      direct

   kind

   Journal article

   origin

   approved-dv-20261101

   priority

   1

   finding

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   jadad

   status

   unassessed

   score

   Not recorded

   citation Snapshot

   count

   Not recorded

   source

   Not recorded

   retrieved At

   Not recorded

   status

   not-assessed

   publication Approval

   status

   approved-for-publication

   approved By

   Ben Korbel

   approved At

   2026-11-01

   assessment

   AI assessed; human approved for publication

   scope

   Qualified research-library summaries. No professional clinical peer review or treatment recommendation is claimed.

   source Revision

   audit-r2-33df2f11c37a

   source Content Hash

   33df2f11c37ac48d21836ade531c0e6186b61eb20da2a91e477eebb3748f1093

   source Access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   editorial Audit

   auditor

   Codex (AI)

   completed At

   2026-10-31T05:11:05.655793+00:00

   prior Content Hash

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   source Verification

   id

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   doi

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   pmid

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   fresh Metadata

   Europe PMC core

   metadata Retrieved

   true

   metadata SHA256

   abbdeeb3a4c53df1872ebdffa257b3603c7ce2c2a3a80a11e383ee2d9e34369d

   claim Check

   Headline finding/design/limitations compared with indexed abstract or accessible primary evidence; retained methods amendments separately adjudicated.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

   applied Proposals

   methods-adult/proposed-candidates.json

   method

   AI editorial assessment of all 130 publication records: compare identity, headline finding, design, relevance and limitations with indexed abstracts or available primary material; adjudicate retained source-supported methods amendments. This is a source-limited publication audit, not an independent full-text systematic review or a clinical guideline.

   limitations

   Abstract-only records do not establish allocation concealment, complete harms reporting or full risk of bias. · No formal independent RoB 2, GRADE appraisal or numerical reconstruction of every effect was performed. · Source-access labels describe retained appraisal evidence; fuller prior appraisals were checked through their source ledgers and selected material, not independently repeated in full. · Publication counts are not independent trial or participant counts; cohort links and overlapping review evidence remain provisional. · A randomized design cross does not indicate benefit, low risk of bias or human approval. No double-blind trial is verified in this release. · No professional clinical peer review is claimed. Recommended content is limited to accurately qualified research summaries.

   study Family Id

   ISRCTN65771265

   family Linkage Uncertain

   false

   approaches

   None recorded

   assessment Record

   id

   dv-adult-therapy-34143803

   title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   authors

   Greene MC · Likindikoki S · Rees S · Bonz A · Kaysen D · Misinzo L · Njau T · Kiluwa S · Turner R · Ventevogel P · Mbwambo JKK · Tol WA

   year

   2021

   journal

   PloS one

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   trial Registration

   ISRCTN65771265

   collection

   language

   intervention Family

   Nguvu integrated psychological and violence-prevention intervention.

   publication Type

   Primary intervention study

   study Family Id

   ISRCTN65771265

   family Linkage Uncertain

   false

   existing Repository Matches

   None recorded

   relevance

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   age

   groups

   adults

   reported Range

   Eligibility 18+; sample mean 33.52 (SD 9.01) years. Observed minimum/maximum not established.

   youth Scope

   No under 18 eligibility; no adolescent subgroup inference.

   country

   Tanzania

   setting

   Nyarugusu refugee camp, Tanzania; Congolese women recruited through local women’s groups, April–September 2017.

   sample Size

   randomized

   311

   analyzed

   275

   description

   43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

   intervention

   description

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women.

   dose

   One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   provider

   Trained nonspecialist Congolese refugee incentive workers with prior basic psychosocial/protection experience.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   finding

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   limitation

   Under-recruitment, baseline imbalances, recruitment after cluster assignment, unmasked self-report, vulnerable assessor masking, complete-case analysis and severity-related intervention dropout limit causal inference. Table 1 reverses the narrative cluster-arm counts; all 43 clusters and individual 158/153 totals are retained.

   design

   type

   Cluster randomized feasibility trial with recruitment after cluster allocation

   randomization Evidence

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   masking

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   crosses

   1

   cross Rationale

   Cluster randomization verified; participants/providers unmasked and assessor masking vulnerable. One cross describes randomized design, not low risk of bias or efficacy.

   quality

   risk Of Bias

   Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

   attrition

   36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

   confounding

   Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

   adverse Findings

   Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

   transfer Limits

   Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

   jadad

   not established

   access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   sources

   1. url

      https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core

      type

      Europe PMC core record sourced from PubMed/MEDLINE

      retrieved At

      2026-10-30T07:15:55.705516+00:00

      identity Verified

      true

      notes

      Primary-publication abstract and bibliographic metadata accessed; canonical PubMed record: https://pubmed.ncbi.nlm.nih.gov/34143803/

      retrieval Query URL

      https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=TITLE_ABS%3A%28%22intimate+partner+violence%22+OR+%22domestic+violence%22+OR+%22battered+women%22%29+AND+TITLE_ABS%3A%28randomized+OR+randomised%29+AND+TITLE_ABS%3A%28therapy+OR+psychological+OR+psychotherapy+OR+cognitive+OR+counseling+OR+counselling+OR+%22motivational+interviewing%22%29&format=json&resultType=core&pageSize=1000

   2. url

      https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

      type

      Crossref DOI registration metadata

      retrieved At

      2026-10-30T07:20:01.423478+00:00

      identity Verified

      true

      notes

      DOI identity cross-check; metadata title: Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial. Correction/update relations checked.

   3. url

      https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

      type

      primary-full-text

      retrieved At

      2026-10-30T08:21:33.147602+00:00

      identity Verified

      true

      notes

      Full primary report methods, results, tables and discussion inspected.

   publication Status

   status

   epublish

   correction Retraction Check

   europe PMCpub Types

   Research Support, Non-U.S. Gov't · research-article · Randomized Controlled Trial · Journal Article

   crossref Update Relations

   None recorded

   crossref Relations

   crossref Checked

   true

   uncertainty

   No comprehensive publisher/Crossmark or registry audit claimed; correction/retraction absence is limited to accessed metadata.

   recommendation Rationale

   Retain as pending candidate evidence; interpret the study design, null outcomes and access limits together.

   review

   status

   pending

   reviewer

   Not recorded

   assessment Status

   assessed

   assessment Notes

   Full primary report methods, results, tables and discussion inspected. · This proposal is not human approval. It revises an existing publication without increasing screened, publication or study-family totals. · Development/pilot cohort used a camp zone excluded from this feasibility trial; it is not the same 311 women. Preserve ISRCTN 65771265 as this randomized family. · Review-ready with the explicit cluster-count inconsistency and limitations; avoid choosing one arm-specific cluster count or claiming efficacy from completers.

   review Ready

   true

   review Readiness

   ai-editorial-audit-complete-release-pending

   research Lane

   adult-therapy

   later Review Evidence

   id

   dv-adult-therapy-34143803

   title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   prior Revision

   r1-35b6a69dd926

   prior Content Hash

   35b6a69dd926de42003041a3008eb1a1c4f66a753118744bb2c29f5528f37a6b

   original

   review Ready

   true

   review Readiness

   ready-with-access-limits

   finding

   Some distress improvement was observed, but no sizeable IPV reduction; baseline imbalance and differential completion limit causal interpretation.

   limitation

   Feasibility cluster trial with imbalanced baseline characteristics and poorer applicability among women with severe IPV.

   adverse Findings

   Adverse-event reporting not established from accessed source; absence of reporting is not evidence of no harm.

   crosses

   1

   access

   abstract

   action

   amend

   hold Current Revision

   true

   cross Verification On Hold

   false

   new Evidence

   Adjusted complete-case estimates did not establish clear distress or IPV benefit. An exploratory high-baseline-IPV subgroup had higher subsequent IPV frequency with Nguvu: mean difference 0.90 (95% CI 0.38–1.42). Three adverse events were judged unlikely related; one participant withdrew fearing neighbors would discover participation.

   revised Interpretation

   Retain the null/uncertain comparative findings and the exploratory adverse-direction signal. Baseline imbalance, multiple testing and differential completion prevent attributing increased violence to treatment. Do not turn this signal into proof of caused harm.

   required Before Approval

   Add the qualified signal, actual adverse-event reporting and attrition limits to a new revision before approval; the available primary report supports this correction.

   source URLs

   https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   source Location

   Results sec020–sec022; Tables 4–5

   assessment Changed

   false

   human Approval

   false

   publication Recommendation

   status

   recommended-summary

   reason

   Suitable as a qualified research-library summary at the stated source-access level. This is not a conclusion that the intervention is effective or safe.

   scope

   Research summary only; no treatment recommendation

   human Release Approval

   false

   editorial Audit

   auditor

   Codex (AI)

   completed At

   2026-10-31T05:11:05.655793+00:00

   prior Content Hash

   35b6a69dd926de42003041a3008eb1a1c4f66a753118744bb2c29f5528f37a6b

   prior Revision

   r1-35b6a69dd926

   prior Source

   frozen-120

   source Verification

   id

   dv-adult-therapy-34143803

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   fresh Metadata

   Europe PMC core

   metadata Retrieved

   true

   metadata SHA256

   abbdeeb3a4c53df1872ebdffa257b3603c7ce2c2a3a80a11e383ee2d9e34369d

   claim Check

   Headline finding/design/limitations compared with indexed abstract or accessible primary evidence; retained methods amendments separately adjudicated.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

   applied Proposals

   methods-adult/proposed-candidates.json

   method

   AI editorial assessment of all 130 publication records: compare identity, headline finding, design, relevance and limitations with indexed abstracts or available primary material; adjudicate retained source-supported methods amendments. This is a source-limited publication audit, not an independent full-text systematic review or a clinical guideline.

   limitations

   Abstract-only records do not establish allocation concealment, complete harms reporting or full risk of bias. · No formal independent RoB 2, GRADE appraisal or numerical reconstruction of every effect was performed. · Source-access labels describe retained appraisal evidence; fuller prior appraisals were checked through their source ledgers and selected material, not independently repeated in full. · Publication counts are not independent trial or participant counts; cohort links and overlapping review evidence remain provisional. · A randomized design cross does not indicate benefit, low risk of bias or human approval. No double-blind trial is verified in this release. · No professional clinical peer review is claimed. Recommended content is limited to accurately qualified research summaries.

   study Design Assessment

   category

   rct

   is Randomized Controlled Trial

   true

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   paper Trust Assessment

   scope

   Paper

   status

   assessed

   score

   2

   randomized Controlled Trial

   true

   peer Reviewed

   true

   blinding

   not-confirmed

   basis

   Cluster randomization verified; participants/providers unmasked and assessor masking vulnerable. One cross describes randomized design, not low risk of bias or efficacy.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   human Approval

   false

   display Crosses

   1

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   jadad

   status

   unassessed

   score

   Not recorded

   evidence

   population

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   intervention

   description

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women.

   dose

   One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   provider

   Trained nonspecialist Congolese refugee incentive workers with prior basic psychosocial/protection experience.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   citation Snapshot

   count

   Not recorded

   source

   Not recorded

   retrieved At

   Not recorded

   status

   not-assessed

   provenance

   Discovered by AI

   content Hash

   33df2f11c37ac48d21836ade531c0e6186b61eb20da2a91e477eebb3748f1093

   revision

   audit-r2-33df2f11c37a

   archive Entries

   None recorded

   collection

   language

   chapter Number

   2

   topic Id

   mindfulness-biofeedback

   topic Title

   Mindfulness Biofeedback / AR / VR / Mixed Reality

   trust Score

   2

2. id

   language-dv-dv-adult-therapy-34143803

   aliases

   None recorded

   title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   authors

   Greene MC; Likindikoki S; Rees S; Bonz A; Kaysen D; Misinzo L; Njau T; Kiluwa S; Turner R; Ventevogel P; Mbwambo JKK; Tol WA

   year

   2021

   journal

   PloS one

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   urls

   https://doi.org/10.1371/journal.pone.0252982 · https://pubmed.ncbi.nlm.nih.gov/34143803/ · https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   collections

   language

   categories

   Clinical & self-report · Methods & context

   targets

   None recorded

   neurotransmitters

   None recorded

   conditions

   anxiety · ptsd · depression

   condition Evidence

   1. id

      anxiety

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         anxiety

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   2. id

      ptsd

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         PTSD

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   3. id

      depression

      evidence

      1. field

         outcomes

         text

         Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

         matched Text

         depression

      scope

      Study population or investigated outcome; not a diagnosis or efficacy claim.

   age Groups

   adults

   age Population

   record Id

   dv-adult-therapy-34143803

   collections

   language

   groups

   adults

   reported Ages

   Eligibility 18+; sample mean 33.52 (SD 9.01) years. Observed minimum/maximum not established.

   youth Scope

   Not recorded

   youth Source Note

   No under 18 eligibility; no adolescent subgroup inference.

   source URL

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core

   basis Type

   source-limited-ai-editorial-assessment

   classification Note

   Original age terms: adults. Programme targets or possible eligibility are not counted as observed ages.

   community Matches

   1. category Id

      domestic-violence

      relation

      direct

   2. category Id

      refugees

      relation

      direct

   kind

   Journal article

   design

   Cluster randomized feasibility trial with recruitment after cluster allocation

   origin

   approved-dv-20261101

   priority

   1

   quotes

   None recorded

   finding

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   summary

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   limitation

   Under-recruitment, baseline imbalances, recruitment after cluster assignment, unmasked self-report, vulnerable assessor masking, complete-case analysis and severity-related intervention dropout limit causal inference. Table 1 reverses the narrative cluster-arm counts; all 43 clusters and individual 158/153 totals are retained.

   evidence

   evidence Type

   Cluster randomized feasibility trial with recruitment after cluster allocation

   intervention

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women. One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   sample

   43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

   measurement

   Psychological distress: depression, anxiety, PTSD; Psychological, physical and sexual IPV frequency; Functional impairment; Exploratory high-baseline-IPV subgroup; PTSD among intervention completers

   timing

   Nine weeks after enrollment, approximately one week after intervention; Nine weeks

   trial Id

   ISRCTN65771265

   relationship Note

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope. See limitation and quality fields; no population-wide clinical recommendation is implied.

   measured Genes

   None recorded

   pathways

   None recorded

   source Access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   quality

   risk Of Bias

   Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

   attrition

   36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

   confounding

   Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

   adverse Findings

   Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

   transfer Limits

   Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

   jadad

   not established

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   population

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   study Design Assessment

   category

   rct

   is Randomized Controlled Trial

   true

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   paper Trust Assessment

   scope

   Paper

   status

   assessed

   score

   2

   randomized Controlled Trial

   true

   peer Reviewed

   true

   blinding

   not-confirmed

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   human Approval

   false

   display Crosses

   2

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   rating Scale

   library-trust-factor/1-3

   jadad

   status

   unassessed

   score

   Not recorded

   citation Snapshot

   count

   Not recorded

   source

   Not recorded

   retrieved At

   Not recorded

   status

   not-assessed

   citation Count

   Not recorded

   publication Approval

   status

   approved-for-publication

   approved By

   Ben Korbel

   approved At

   2026-11-01

   assessment

   AI assessed; human approved for publication

   scope

   Qualified research-library summaries. No professional clinical peer review or treatment recommendation is claimed.

   source Revision

   audit-r2-33df2f11c37a

   source Content Hash

   33df2f11c37ac48d21836ade531c0e6186b61eb20da2a91e477eebb3748f1093

   source Access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   study Family Id

   ISRCTN65771265

   family Linkage Uncertain

   false

   approaches

   None recorded

   record Id

   dv-adult-therapy-34143803

   source Pages

   None recorded

   editorial Audit

   auditor

   Codex (AI)

   completed At

   2026-10-31T05:11:05.655793+00:00

   prior Content Hash

   35b6a69dd926de42003041a3008eb1a1c4f66a753118744bb2c29f5528f37a6b

   prior Revision

   r1-35b6a69dd926

   prior Source

   frozen-120

   source Verification

   id

   dv-adult-therapy-34143803

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   fresh Metadata

   Europe PMC core

   metadata Retrieved

   true

   metadata SHA256

   abbdeeb3a4c53df1872ebdffa257b3603c7ce2c2a3a80a11e383ee2d9e34369d

   claim Check

   Headline finding/design/limitations compared with indexed abstract or accessible primary evidence; retained methods amendments separately adjudicated.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

   applied Proposals

   methods-adult/proposed-candidates.json

   method

   AI editorial assessment of all 130 publication records: compare identity, headline finding, design, relevance and limitations with indexed abstracts or available primary material; adjudicate retained source-supported methods amendments. This is a source-limited publication audit, not an independent full-text systematic review or a clinical guideline.

   limitations

   Abstract-only records do not establish allocation concealment, complete harms reporting or full risk of bias. · No formal independent RoB 2, GRADE appraisal or numerical reconstruction of every effect was performed. · Source-access labels describe retained appraisal evidence; fuller prior appraisals were checked through their source ledgers and selected material, not independently repeated in full. · Publication counts are not independent trial or participant counts; cohort links and overlapping review evidence remain provisional. · A randomized design cross does not indicate benefit, low risk of bias or human approval. No double-blind trial is verified in this release. · No professional clinical peer review is claimed. Recommended content is limited to accurately qualified research summaries.

   assessment Record

   id

   dv-adult-therapy-34143803

   title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   authors

   Greene MC · Likindikoki S · Rees S · Bonz A · Kaysen D · Misinzo L · Njau T · Kiluwa S · Turner R · Ventevogel P · Mbwambo JKK · Tol WA

   year

   2021

   journal

   PloS one

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   trial Registration

   ISRCTN65771265

   collection

   language

   intervention Family

   Nguvu integrated psychological and violence-prevention intervention.

   publication Type

   Primary intervention study

   study Family Id

   ISRCTN65771265

   family Linkage Uncertain

   false

   existing Repository Matches

   None recorded

   relevance

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   age

   groups

   adults

   reported Range

   Eligibility 18+; sample mean 33.52 (SD 9.01) years. Observed minimum/maximum not established.

   youth Scope

   No under 18 eligibility; no adolescent subgroup inference.

   country

   Tanzania

   setting

   Nyarugusu refugee camp, Tanzania; Congolese women recruited through local women’s groups, April–September 2017.

   sample Size

   randomized

   311

   analyzed

   275

   description

   43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

   intervention

   description

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women.

   dose

   One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   provider

   Trained nonspecialist Congolese refugee incentive workers with prior basic psychosocial/protection experience.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   finding

   Nguvu was feasible for some refugee women, but the adjusted randomized comparison does not clearly establish psychological or IPV benefit. Severe IPV predicted lower completion; an exploratory subgroup showed higher subsequent IPV. No long-term durability was tested.

   limitation

   Under-recruitment, baseline imbalances, recruitment after cluster assignment, unmasked self-report, vulnerable assessor masking, complete-case analysis and severity-related intervention dropout limit causal inference. Table 1 reverses the narrative cluster-arm counts; all 43 clusters and individual 158/153 totals are retained.

   design

   type

   Cluster randomized feasibility trial with recruitment after cluster allocation

   randomization Evidence

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   masking

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   crosses

   1

   cross Rationale

   Cluster randomization verified; participants/providers unmasked and assessor masking vulnerable. One cross describes randomized design, not low risk of bias or efficacy.

   quality

   risk Of Bias

   Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

   attrition

   36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

   confounding

   Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

   adverse Findings

   Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

   transfer Limits

   Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

   jadad

   not established

   access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   sources

   1. url

      https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core

      type

      Europe PMC core record sourced from PubMed/MEDLINE

      retrieved At

      2026-10-30T07:15:55.705516+00:00

      identity Verified

      true

      notes

      Primary-publication abstract and bibliographic metadata accessed; canonical PubMed record: https://pubmed.ncbi.nlm.nih.gov/34143803/

      retrieval Query URL

      https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=TITLE_ABS%3A%28%22intimate+partner+violence%22+OR+%22domestic+violence%22+OR+%22battered+women%22%29+AND+TITLE_ABS%3A%28randomized+OR+randomised%29+AND+TITLE_ABS%3A%28therapy+OR+psychological+OR+psychotherapy+OR+cognitive+OR+counseling+OR+counselling+OR+%22motivational+interviewing%22%29&format=json&resultType=core&pageSize=1000

   2. url

      https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

      type

      Crossref DOI registration metadata

      retrieved At

      2026-10-30T07:20:01.423478+00:00

      identity Verified

      true

      notes

      DOI identity cross-check; metadata title: Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial. Correction/update relations checked.

   3. url

      https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

      type

      primary-full-text

      retrieved At

      2026-10-30T08:21:33.147602+00:00

      identity Verified

      true

      notes

      Full primary report methods, results, tables and discussion inspected.

   publication Status

   status

   epublish

   correction Retraction Check

   europe PMCpub Types

   Research Support, Non-U.S. Gov't · research-article · Randomized Controlled Trial · Journal Article

   crossref Update Relations

   None recorded

   crossref Relations

   crossref Checked

   true

   uncertainty

   No comprehensive publisher/Crossmark or registry audit claimed; correction/retraction absence is limited to accessed metadata.

   recommendation Rationale

   Retain as pending candidate evidence; interpret the study design, null outcomes and access limits together.

   review

   status

   pending

   reviewer

   Not recorded

   assessment Status

   assessed

   assessment Notes

   Full primary report methods, results, tables and discussion inspected. · This proposal is not human approval. It revises an existing publication without increasing screened, publication or study-family totals. · Development/pilot cohort used a camp zone excluded from this feasibility trial; it is not the same 311 women. Preserve ISRCTN 65771265 as this randomized family. · Review-ready with the explicit cluster-count inconsistency and limitations; avoid choosing one arm-specific cluster count or claiming efficacy from completers.

   review Ready

   true

   review Readiness

   ai-editorial-audit-complete-release-pending

   research Lane

   adult-therapy

   later Review Evidence

   id

   dv-adult-therapy-34143803

   title

   Evaluation of an integrated intervention to reduce psychological distress and intimate partner violence in refugees: Results from the Nguvu cluster randomized feasibility trial.

   prior Revision

   r1-35b6a69dd926

   prior Content Hash

   35b6a69dd926de42003041a3008eb1a1c4f66a753118744bb2c29f5528f37a6b

   original

   review Ready

   true

   review Readiness

   ready-with-access-limits

   finding

   Some distress improvement was observed, but no sizeable IPV reduction; baseline imbalance and differential completion limit causal interpretation.

   limitation

   Feasibility cluster trial with imbalanced baseline characteristics and poorer applicability among women with severe IPV.

   adverse Findings

   Adverse-event reporting not established from accessed source; absence of reporting is not evidence of no harm.

   crosses

   1

   access

   abstract

   action

   amend

   hold Current Revision

   true

   cross Verification On Hold

   false

   new Evidence

   Adjusted complete-case estimates did not establish clear distress or IPV benefit. An exploratory high-baseline-IPV subgroup had higher subsequent IPV frequency with Nguvu: mean difference 0.90 (95% CI 0.38–1.42). Three adverse events were judged unlikely related; one participant withdrew fearing neighbors would discover participation.

   revised Interpretation

   Retain the null/uncertain comparative findings and the exploratory adverse-direction signal. Baseline imbalance, multiple testing and differential completion prevent attributing increased violence to treatment. Do not turn this signal into proof of caused harm.

   required Before Approval

   Add the qualified signal, actual adverse-event reporting and attrition limits to a new revision before approval; the available primary report supports this correction.

   source URLs

   https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   source Location

   Results sec020–sec022; Tables 4–5

   assessment Changed

   false

   human Approval

   false

   publication Recommendation

   status

   recommended-summary

   reason

   Suitable as a qualified research-library summary at the stated source-access level. This is not a conclusion that the intervention is effective or safe.

   scope

   Research summary only; no treatment recommendation

   human Release Approval

   false

   editorial Audit

   auditor

   Codex (AI)

   completed At

   2026-10-31T05:11:05.655793+00:00

   prior Content Hash

   35b6a69dd926de42003041a3008eb1a1c4f66a753118744bb2c29f5528f37a6b

   prior Revision

   r1-35b6a69dd926

   prior Source

   frozen-120

   source Verification

   id

   dv-adult-therapy-34143803

   doi

   10.1371/journal.pone.0252982

   pmid

   34143803

   fresh Metadata

   Europe PMC core

   metadata Retrieved

   true

   metadata SHA256

   abbdeeb3a4c53df1872ebdffa257b3603c7ce2c2a3a80a11e383ee2d9e34369d

   claim Check

   Headline finding/design/limitations compared with indexed abstract or accessible primary evidence; retained methods amendments separately adjudicated.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982

   applied Proposals

   methods-adult/proposed-candidates.json

   method

   AI editorial assessment of all 130 publication records: compare identity, headline finding, design, relevance and limitations with indexed abstracts or available primary material; adjudicate retained source-supported methods amendments. This is a source-limited publication audit, not an independent full-text systematic review or a clinical guideline.

   limitations

   Abstract-only records do not establish allocation concealment, complete harms reporting or full risk of bias. · No formal independent RoB 2, GRADE appraisal or numerical reconstruction of every effect was performed. · Source-access labels describe retained appraisal evidence; fuller prior appraisals were checked through their source ledgers and selected material, not independently repeated in full. · Publication counts are not independent trial or participant counts; cohort links and overlapping review evidence remain provisional. · A randomized design cross does not indicate benefit, low risk of bias or human approval. No double-blind trial is verified in this release. · No professional clinical peer review is claimed. Recommended content is limited to accurately qualified research summaries.

   study Design Assessment

   category

   rct

   is Randomized Controlled Trial

   true

   basis

   Independent investigator used unrestricted Stata 14 random sequence to allocate all 43 women’s groups simultaneously, then recruited individual women by cluster assignment. Narrative says 21 Nguvu/22 usual-care clusters; Table 1 labels the reverse. Individual allocations 158/153 are consistent.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   paper Trust Assessment

   scope

   Paper

   status

   assessed

   score

   2

   randomized Controlled Trial

   true

   peer Reviewed

   true

   blinding

   not-confirmed

   basis

   Cluster randomization verified; participants/providers unmasked and assessor masking vulnerable. One cross describes randomized design, not low risk of bias or efficacy.

   sources

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   review Scope

   full-text

   human Approval

   false

   display Crosses

   1

   masking Roles

   participants

   Explicitly unmasked.

   providers

   Explicitly unmasked.

   assessors

   Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

   analysts

   Not established from accessed source.

   jadad

   status

   unassessed

   score

   Not recorded

   evidence

   population

   relation

   direct

   population

   Congolese refugee women with past-year IPV and elevated psychological distress.

   exposure Evidence

   Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

   rationale

   Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

   transfer Limit

   See limitation and quality fields; no population-wide clinical recommendation is implied.

   intervention

   description

   Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women.

   dose

   One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

   provider

   Trained nonspecialist Congolese refugee incentive workers with prior basic psychosocial/protection experience.

   comparator

   Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

   outcomes

   1. name

      Psychological distress: depression, anxiety, PTSD

      follow Up

      Nine weeks after enrollment, approximately one week after intervention

      result

      Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

      effect Estimate

      Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

      uncertainty

      Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

      primary Status

      primary

   2. name

      Psychological, physical and sexual IPV frequency

      follow Up

      Nine weeks

      result

      No clear comparative benefit after baseline adjustment.

      effect Estimate

      Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

      uncertainty

      Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

      primary Status

      primary

   3. name

      Functional impairment

      follow Up

      Nine weeks

      result

      No clear comparative difference.

      effect Estimate

      Adjusted MD−0.14 (95% CI−0.37, 0.09).

      uncertainty

      Model 3 n 272.

      primary Status

      secondary

   4. name

      Exploratory high-baseline-IPV subgroup

      follow Up

      Nine weeks

      result

      Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

      effect Estimate

      Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

      uncertainty

      Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

      primary Status

      exploratory

   5. name

      PTSD among intervention completers

      follow Up

      Nine weeks

      result

      Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

      effect Estimate

      MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

      uncertainty

      Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

      primary Status

      exploratory per-protocol

   access

   level

   full-text

   source URLs

   https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

   retrieved At

   2026-10-30T08:21:33.147602+00:00

   citation Snapshot

   count

   Not recorded

   source

   Not recorded

   retrieved At

   Not recorded

   status

   not-assessed

   provenance

   Discovered by AI

   content Hash

   33df2f11c37ac48d21836ade531c0e6186b61eb20da2a91e477eebb3748f1093

   revision

   audit-r2-33df2f11c37a

   archive Entries

   None recorded

   collection

   language

   chapter Number

   5

   topic Id

   domestic-family-violence

   topic Title

   Domestic & Family Violence

   trust Score

   2

evidence Type

Cluster randomized feasibility trial with recruitment after cluster allocation

intervention

Nguvu integrates shortened cognitive processing therapy with advocacy counselling, adapted for refugee women. One individual plus seven weekly group sessions; groups 6–13, facilitated in pairs. Mean 5.4/8 attended; 92/158 (58.2%)completed≥6, 47/158 all 8, 13/158 none.

comparator

Information about existing protection/mental-health services and usual humanitarian case management/referrals; Nguvu participants could also access these services.

sample

43 groups randomized before individual recruitment; 311 enrolled women assigned 158 Nguvu/153 usual care. Follow-up 275 (143/132); adjusted main model 272 and completer analysis 219. Target 400 was not achieved. Narrative and Table 1 reverse cluster-arm counts; retain 43 total and flag discrepancy.

measurement

Psychological distress: depression, anxiety, PTSD; Psychological, physical and sexual IPV frequency; Functional impairment; Exploratory high-baseline-IPV subgroup; PTSD among intervention completers

timing

Nine weeks after enrollment, approximately one week after intervention; Nine weeks

trial Id

ISRCTN65771265

relationship Note

Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope. See limitation and quality fields; no population-wide clinical recommendation is implied.

measured Genes

None recorded

pathways

None recorded

source Access

level

full-text

source URLs

https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:34143803%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pone.0252982 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC8213126/fullTextXML

retrieved At

2026-10-30T08:21:33.147602+00:00

outcomes

1. name

   Psychological distress: depression, anxiety, PTSD

   follow Up

   Nine weeks after enrollment, approximately one week after intervention

   result

   Baseline-adjusted randomized complete-case estimates do not clearly exclude no benefit; apparent unadjusted differences attenuate.

   effect Estimate

   Depression MD−0.14 (95% CI−0.30, 0.03); anxiety−0.12 (−0.30, 0.06); PTSD−0.18 (−0.36, 0.00), Model 3 n 272.

   uncertainty

   Cluster mixed models adjust demographics and baseline outcome imbalance; PTSD upperCI rounded to 0.00. Not evidence of a definitive efficacy effect.

   primary Status

   primary

2. name

   Psychological, physical and sexual IPV frequency

   follow Up

   Nine weeks

   result

   No clear comparative benefit after baseline adjustment.

   effect Estimate

   Log-frequency MD psychological 0.10 (95% CI−0.04, 0.24); physical 0.09 (−0.03, 0.21); sexual−0.03 (−0.24, 0.17).

   uncertainty

   Positive values favor usual care; all intervals include zero. These are log-transformed frequency outcomes, not risk ratios.

   primary Status

   primary

3. name

   Functional impairment

   follow Up

   Nine weeks

   result

   No clear comparative difference.

   effect Estimate

   Adjusted MD−0.14 (95% CI−0.37, 0.09).

   uncertainty

   Model 3 n 272.

   primary Status

   secondary

4. name

   Exploratory high-baseline-IPV subgroup

   follow Up

   Nine weeks

   result

   Higher subsequent IPV frequency reported with Nguvu among women above the baseline IPV median.

   effect Estimate

   Exploratory subgroup MD 0.90 (95% CI 0.38, 1.42), Table 5.

   uncertainty

   Underpowered moderator tests, multiple comparisons, baseline imbalance and differential completion; a signal to retain, not established treatment-caused harm.

   primary Status

   exploratory

5. name

   PTSD among intervention completers

   follow Up

   Nine weeks

   result

   Selected completer analysis favored Nguvu; it must not replace the randomized comparison.

   effect Estimate

   MD−0.22 (95% CI−0.43,−0.01), Model 4 n 219.

   uncertainty

   Treatment completion associated with baseline IPV severity; per-protocol comparison is vulnerable to selection bias.

   primary Status

   exploratory per-protocol

quality

risk Of Bias

Important concerns from baseline mental-health/IPV imbalance, post-allocation recruitment, unmasked self-report and possible assessor unmasking; no formal numeric rating.

attrition

36/311 (11.6%) lacked endline: 15/158 Nguvu, 21/153 usual care. Eighteen relocated/resettled. Later resettlement stages predicted loss. One withdrew fearing neighbors would learn of participation. Intervention completion 92/158 is distinct from study follow-up 143/158.

confounding

Models 1–3 labeled ITT by authors are complete-case randomized-group comparisons, not all 311 participants. Model 3 controls baseline imbalances; favorable per-protocol PTSD estimate is selected. Moderator tests are exploratory, multiple and underpowered.

adverse Findings

Three adverse events reviewed by DSMB/IRB were judged unlikely due to participation and consistent with ongoing IPV; participants were connected to services. Exploratory high-baseline-IPV group had higher subsequent IPV frequency with Nguvu; not causal proof. One privacy-related withdrawal.

transfer Limits

Adult Congolese women in established refugee groups with past-year physical/sexual IPV and elevated distress. Imminent suicidality/severe psychiatric impairment excluded; no durability beyond nine weeks.

jadad

not established

masking Roles

participants

Explicitly unmasked.

providers

Explicitly unmasked.

assessors

Not informed of allocation, but familiar with Nguvu and could infer it from participants at endline; integrity not established.

analysts

Not established from accessed source.

population

relation

direct

population

Congolese refugee women with past-year IPV and elevated psychological distress.

exposure Evidence

Past-year physical/sexual IPV on Abuse Assessment Screen plus elevated distress; married/in relationship in past 12 months. Psychological-only IPV did not independently meet entry criteria.

rationale

Explicit domestic/intimate-partner violence exposure in the studied population; psychological intervention is within Language scope.

transfer Limit

See limitation and quality fields; no population-wide clinical recommendation is implied.

status

unassessed

score

Not recorded

1. id

   anxiety

   evidence

   1. field

      outcomes

      text

      Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

      matched Text

      anxiety

   scope

   Study population or investigated outcome; not a diagnosis or efficacy claim.

2. id

   ptsd

   evidence

   1. field

      outcomes

      text

      Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

      matched Text

      PTSD

   scope

   Study population or investigated outcome; not a diagnosis or efficacy claim.

3. id

   depression

   evidence

   1. field

      outcomes

      text

      Psychological distress: depression, anxiety, PTSD | Psychological, physical and sexual IPV frequency | Functional impairment | Exploratory high-baseline-IPV subgroup | PTSD among intervention completers

      matched Text

      depression

   scope

   Study population or investigated outcome; not a diagnosis or efficacy claim.

anxiety · ptsd · depression

2

status

not-indexed

retrieval Available

false