Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
Keynejad RC; Bitew T; Sorsdahl K; Myers B; Honikman S; Medhin G; Deyessa N; Mulushoa A; Fekadu E; Howard LM; Hanlon C · PLOS global public health · 2023 · Randomized controlled feasibility study with material allocation-protocol deviations
Original publication · Original publication · Original publication · Original publication · Original publication
Recorded summary
PST-IPV was implementable with adaptations, but serious allocation errors, 25% missing follow-up and short descriptive assessment preclude an efficacy conclusion. One serious assault event was reported without arm or causal attribution.
Recorded limitations
Seventeen women with psychological/emotional IPV had no chance of assignment toPST-IPV; baseline imbalance suggests possible nonrandom allocation. Twelve of 39 assessments occurred before 9 weeks. Underpowered feasibility, missing follow-up, provider fidelity problems and overlapping IPV recall periods limit interpretation.
Evidence and provenance
Chapter Trust Factor uses a minimum of three distinct qualifying studies. Publication records retain their own evidence and assessment.
Study design and assessment
- design
- Randomized controlled feasibility study with material allocation-protocol deviations
- assessment
- category
- rct
- is Randomized Controlled Trial
- true
- basis
- Independent statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- review Scope
- full-text
- trust Factor
- scope
- Paper
- status
- assessed
- score
- 2
- randomized Controlled Trial
- true
- peer Reviewed
- true
- blinding
- not-confirmed
- basis
- Independent statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- review Scope
- full-text
- human Approval
- false
- display Crosses
- 2
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- rating Scale
- library-trust-factor/1-3
- jadad
- status
- unassessed
- score
- Not recorded
- evidence
- evidence Type
- Randomized controlled feasibility study with material allocation-protocol deviations
- intervention
- Four-session problem-solving therapy adapted with trauma/IPV-informed training, risk awareness and avoidance of victim blaming; sessions address participants’ chosen problems. Four sessions within 8 weeks; mean session durations approximately 32–51 minutes. 19/25 completed all 4; 5 attended none, 1 attended one.
- comparator
- Four-session standard PST (12 women) or enhanced usual care (15 women: well-being leaflet and local support information). All arms additional to routine antenatal care. Shared comparator structure with linked depression feasibility trial.
- sample
- Final 25 PST-IPV/12 standard PST/15 enhanced usual care. Only 35 entered intended three-arm allocation (25/5/5); 17 psychological/emotional-IPV women were wrongly routed to linked two-arm table. Follow-up 19/25, 8/12, 12/15.
- measurement
- Implementation feasibility; Acceptability and delivery fidelity; Depressive symptoms and IPV; Safety
- timing
- Recruitment 35 days; follow-up planned 9 weeks; Four-session intervention over 8 weeks; Planned 9 weeks; 12/39 assessments occurred early; During trial and births by data-collection end
- trial Id
- PACTR202002513482084
- 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:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- outcomes
- name
- Implementation feasibility
- follow Up
- Recruitment 35 days; follow-up planned 9 weeks
- result
- 52 eligiblewomen enrolled; 39/52 completed assessment; delivery feasible with changes required to randomization, provider skills and scheduling.
- effect Estimate
- Not recorded
- uncertainty
- Primary aim was feasibility, not powered comparative efficacy.
- primary Status
- primary
- name
- Acceptability and delivery fidelity
- follow Up
- Four-session intervention over 8 weeks
- result
- 19/25 PST-IPV and 8/12 standard PST completed all 4 sessions. Providers sometimes ignored IPV disclosures; risk/confidentiality discussion needed improvement.
- effect Estimate
- Not recorded
- uncertainty
- IPV was infrequently discussed and then for 1–4 minutes. Completion alone does not establish competent IPV response.
- primary Status
- secondary implementation
- name
- Depressive symptoms and IPV
- follow Up
- Planned 9 weeks; 12/39 assessments occurred early
- result
- Descriptive symptoms/IPV scores fell in several arms; no powered causal comparison or effect size established.
- effect Estimate
- Follow-up medianPHQ-9: 6 PST-IPV, 6 standard PST, 4 enhanced usual care in the full sample; these are descriptive medians with unequal selected follow-up denominators.
- uncertainty
- No significant-benefit claim. IPV recall windows overlapped; misallocation confounds group comparison.
- primary Status
- pilot clinical measures
- name
- Safety
- follow Up
- During trial and births by data-collection end
- result
- One serious adverse event: assault by husband. Two obstructed/prolonged-labour complications among 29 participants who had delivered.
- effect Estimate
- Not recorded
- uncertainty
- Assault arm and relatedness to participation not reported; incomplete obstetric follow-up. Safe-delivery conclusion is not zero-harm evidence.
- primary Status
- secondary implementation
- quality
- risk Of Bias
- High concern for comparative causal inference because 17/52 entered the wrong allocation table and arm-closing rules generated uneven groups; masked assessors/analysts do not repair this. No formal RoB/Jadad score.
- attrition
- 13/52 (25%)missing follow-up: 5 moved, 4 untraceable, 4 declined (often postnatal confinement). Arm follow-up 19/25, 8/12, 12/15. Nonresponders younger (median 20 vs 25.5) and apparently more trauma-symptomatic. 12/39 assessments occurred 37–61 days rather than target 63.
- confounding
- Three-arm intended sample 35 and full sample 52 are reported separately. Shared controls with linked depression trial must not be counted as independent evidence. No powered efficacy test; differences in clinical medians are not treatment effects.
- adverse Findings
- One serious adverse event was assault by husband; assignment and treatment relatedness unreported. Two obstructed/prolonged-labour complications among 29 delivered. Independent assessors found risk/confidentiality discussions needed improvement, and some providers did not respond to IPV disclosure.
- transfer Limits
- Rural Amharic-speaking pregnant women with depressive symptoms and IPV; imminent risk/psychosis/emergency care excluded. No long-term follow-up, no established adolescent subgroup effect.
- jadad
- not established
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- population
- relation
- direct
- population
- Pregnant women with depressive symptoms and past-year IPV.
- exposure Evidence
- Pregnant 12–34 weeks, depressive symptoms PHQ-9≥5 plus functional impact and past-year IPV by non-graphic or WHO screen; psychological/emotional IPV qualifies.
- 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.
Topics and recorded topic scores
- key
- language:domestic-family-violence
- title
- Domestic & Family Violence
- collection
- language
- trust Score
- 2
Citation snapshot and identifiers
- id
- dv-adult-therapy-37889918
- doi
- 10.1371/journal.pgph.0002054
- pmid
- 37889918
- citation Snapshot
- count
- Not recorded
- source
- Not recorded
- retrieved At
- Not recorded
- status
- not-assessed
- citations By Collection
- language
- Not recorded
Complete approved library record
- 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-r2-54991bc67916
- source Content Hash
- 54991bc67916d3d5951f9eb1eb38c1cdb7278e19baa3e46ec94720f3dd5cbd33
- source Access
- level
- full-text
- source URLs
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- editorial Audit
- auditor
- Codex (AI)
- completed At
- 2026-10-31T05:11:05.655793+00:00
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- a8b708e75848ba81679661cf66d65e1b1cb8bbb93e019a178f14983d0ef3604b
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- source Verification
- id
- dv-adult-therapy-37889918
- doi
- 10.1371/journal.pgph.0002054
- pmid
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- fresh Metadata
- Europe PMC core
- metadata Retrieved
- true
- metadata SHA256
- eab456b0d5f24ba0913467792baae86ab5dfb34b0ae53f13bcf97012e783d4d0
- 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:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054
- 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
- PACTR202002513482084
- family Linkage Uncertain
- false
- approaches
- None recorded
- id
- dv-adult-therapy-37889918
- aliases
- None recorded
- title
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- journal
- PLOS global public health
- neurotransmitters
- None recorded
- year
- 2023
- authors
- Keynejad RC; Bitew T; Sorsdahl K; Myers B; Honikman S; Medhin G; Deyessa N; Mulushoa A; Fekadu E; Howard LM; Hanlon C
- design
- Randomized controlled feasibility study with material allocation-protocol deviations
- kind
- Journal article
- identity Conflict
- Not recorded
- doi
- 10.1371/journal.pgph.0002054
- pmid
- 37889918
- urls
https://doi.org/10.1371/journal.pgph.0002054 · https://pubmed.ncbi.nlm.nih.gov/37889918/ · https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- collections
language
- categories
Clinical & self-report · Methods & context
- targets
- None recorded
- priority
- 1
- quotes
- None recorded
- summary
- PST-IPV was implementable with adaptations, but serious allocation errors, 25% missing follow-up and short descriptive assessment preclude an efficacy conclusion. One serious assault event was reported without arm or causal attribution.
- limitation
- Seventeen women with psychological/emotional IPV had no chance of assignment toPST-IPV; baseline imbalance suggests possible nonrandom allocation. Twelve of 39 assessments occurred before 9 weeks. Underpowered feasibility, missing follow-up, provider fidelity problems and overlapping IPV recall periods limit interpretation.
- citation Count
- Not recorded
- citation Snapshot
- count
- Not recorded
- source
- Not recorded
- retrieved At
- Not recorded
- status
- not-assessed
- study Design Assessment
- category
- rct
- is Randomized Controlled Trial
- true
- basis
- Independent statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/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 statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- review Scope
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- human Approval
- false
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- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- rating Scale
- library-trust-factor/1-3
- citations By Collection
- language
- Not recorded
- topics
- key
- language:domestic-family-violence
- title
- Domestic & Family Violence
- collection
- language
- trust Score
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- journal Key
- plosglobalpublichealth
- journal Label
- PLOS global public health
- chapter Entries
- id
- language-dv-dv-adult-therapy-37889918
- aliases
- None recorded
- title
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- authors
- Keynejad RC; Bitew T; Sorsdahl K; Myers B; Honikman S; Medhin G; Deyessa N; Mulushoa A; Fekadu E; Howard LM; Hanlon C
- year
- 2023
- journal
- PLOS global public health
- doi
- 10.1371/journal.pgph.0002054
- pmid
- 37889918
- urls
https://doi.org/10.1371/journal.pgph.0002054 · https://pubmed.ncbi.nlm.nih.gov/37889918/ · https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- collections
language
- categories
Clinical & self-report · Methods & context
- targets
- None recorded
- neurotransmitters
- None recorded
- conditions
depression
- condition Evidence
- id
- depression
- evidence
- field
- title
- text
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- matched Text
- depressive
- field
- population
- text
- Pregnant women with depressive symptoms and past-year IPV.
- matched Text
- depressive
- field
- outcomes
- text
- Implementation feasibility | Acceptability and delivery fidelity | Depressive symptoms and IPV | Safety
- matched Text
- Depressive
- scope
- Study population or investigated outcome; not a diagnosis or efficacy claim.
- age Groups
adults
- age Population
- record Id
- dv-adult-therapy-37889918
- collections
language
- groups
adults
- reported Ages
- Eligibility≥16 years; arm medians 25–25.5 years. Actual minimum/maximum and count under 18 not reported.
- youth Scope
- Not recorded
- youth Source Note
- Adolescent eligibility is not proof of enrolled adolescent participants; no adolescent-specific outcomes.
- source URL
- https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core
- basis Type
- source-limited-ai-editorial-assessment
- classification Note
- Original age terms: adults, adolescent eligibility. Programme targets or possible eligibility are not counted as observed ages.
- community Matches
- category Id
- domestic-violence
- relation
- direct
- kind
- Journal article
- design
- Randomized controlled feasibility study with material allocation-protocol deviations
- origin
- approved-dv-20261101
- priority
- 1
- quotes
- None recorded
- finding
- PST-IPV was implementable with adaptations, but serious allocation errors, 25% missing follow-up and short descriptive assessment preclude an efficacy conclusion. One serious assault event was reported without arm or causal attribution.
- summary
- PST-IPV was implementable with adaptations, but serious allocation errors, 25% missing follow-up and short descriptive assessment preclude an efficacy conclusion. One serious assault event was reported without arm or causal attribution.
- limitation
- Seventeen women with psychological/emotional IPV had no chance of assignment toPST-IPV; baseline imbalance suggests possible nonrandom allocation. Twelve of 39 assessments occurred before 9 weeks. Underpowered feasibility, missing follow-up, provider fidelity problems and overlapping IPV recall periods limit interpretation.
- evidence
- evidence Type
- Randomized controlled feasibility study with material allocation-protocol deviations
- intervention
- Four-session problem-solving therapy adapted with trauma/IPV-informed training, risk awareness and avoidance of victim blaming; sessions address participants’ chosen problems. Four sessions within 8 weeks; mean session durations approximately 32–51 minutes. 19/25 completed all 4; 5 attended none, 1 attended one.
- comparator
- Four-session standard PST (12 women) or enhanced usual care (15 women: well-being leaflet and local support information). All arms additional to routine antenatal care. Shared comparator structure with linked depression feasibility trial.
- sample
- Final 25 PST-IPV/12 standard PST/15 enhanced usual care. Only 35 entered intended three-arm allocation (25/5/5); 17 psychological/emotional-IPV women were wrongly routed to linked two-arm table. Follow-up 19/25, 8/12, 12/15.
- measurement
- Implementation feasibility; Acceptability and delivery fidelity; Depressive symptoms and IPV; Safety
- timing
- Recruitment 35 days; follow-up planned 9 weeks; Four-session intervention over 8 weeks; Planned 9 weeks; 12/39 assessments occurred early; During trial and births by data-collection end
- trial Id
- PACTR202002513482084
- 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:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- outcomes
- name
- Implementation feasibility
- follow Up
- Recruitment 35 days; follow-up planned 9 weeks
- result
- 52 eligiblewomen enrolled; 39/52 completed assessment; delivery feasible with changes required to randomization, provider skills and scheduling.
- effect Estimate
- Not recorded
- uncertainty
- Primary aim was feasibility, not powered comparative efficacy.
- primary Status
- primary
- name
- Acceptability and delivery fidelity
- follow Up
- Four-session intervention over 8 weeks
- result
- 19/25 PST-IPV and 8/12 standard PST completed all 4 sessions. Providers sometimes ignored IPV disclosures; risk/confidentiality discussion needed improvement.
- effect Estimate
- Not recorded
- uncertainty
- IPV was infrequently discussed and then for 1–4 minutes. Completion alone does not establish competent IPV response.
- primary Status
- secondary implementation
- name
- Depressive symptoms and IPV
- follow Up
- Planned 9 weeks; 12/39 assessments occurred early
- result
- Descriptive symptoms/IPV scores fell in several arms; no powered causal comparison or effect size established.
- effect Estimate
- Follow-up medianPHQ-9: 6 PST-IPV, 6 standard PST, 4 enhanced usual care in the full sample; these are descriptive medians with unequal selected follow-up denominators.
- uncertainty
- No significant-benefit claim. IPV recall windows overlapped; misallocation confounds group comparison.
- primary Status
- pilot clinical measures
- name
- Safety
- follow Up
- During trial and births by data-collection end
- result
- One serious adverse event: assault by husband. Two obstructed/prolonged-labour complications among 29 participants who had delivered.
- effect Estimate
- Not recorded
- uncertainty
- Assault arm and relatedness to participation not reported; incomplete obstetric follow-up. Safe-delivery conclusion is not zero-harm evidence.
- primary Status
- secondary implementation
- quality
- risk Of Bias
- High concern for comparative causal inference because 17/52 entered the wrong allocation table and arm-closing rules generated uneven groups; masked assessors/analysts do not repair this. No formal RoB/Jadad score.
- attrition
- 13/52 (25%)missing follow-up: 5 moved, 4 untraceable, 4 declined (often postnatal confinement). Arm follow-up 19/25, 8/12, 12/15. Nonresponders younger (median 20 vs 25.5) and apparently more trauma-symptomatic. 12/39 assessments occurred 37–61 days rather than target 63.
- confounding
- Three-arm intended sample 35 and full sample 52 are reported separately. Shared controls with linked depression trial must not be counted as independent evidence. No powered efficacy test; differences in clinical medians are not treatment effects.
- adverse Findings
- One serious adverse event was assault by husband; assignment and treatment relatedness unreported. Two obstructed/prolonged-labour complications among 29 delivered. Independent assessors found risk/confidentiality discussions needed improvement, and some providers did not respond to IPV disclosure.
- transfer Limits
- Rural Amharic-speaking pregnant women with depressive symptoms and IPV; imminent risk/psychosis/emergency care excluded. No long-term follow-up, no established adolescent subgroup effect.
- jadad
- not established
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- population
- relation
- direct
- population
- Pregnant women with depressive symptoms and past-year IPV.
- exposure Evidence
- Pregnant 12–34 weeks, depressive symptoms PHQ-9≥5 plus functional impact and past-year IPV by non-graphic or WHO screen; psychological/emotional IPV qualifies.
- 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 statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/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 statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- review Scope
- full-text
- human Approval
- false
- display Crosses
- 2
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
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- citation Snapshot
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- source
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- 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-r2-54991bc67916
- source Content Hash
- 54991bc67916d3d5951f9eb1eb38c1cdb7278e19baa3e46ec94720f3dd5cbd33
- source Access
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https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
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- study Family Id
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- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054
- 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-37889918
- title
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- authors
Keynejad RC · Bitew T · Sorsdahl K · Myers B · Honikman S · Medhin G · Deyessa N · Mulushoa A · Fekadu E · Howard LM · Hanlon C
- year
- 2023
- journal
- PLOS global public health
- doi
- 10.1371/journal.pgph.0002054
- pmid
- 37889918
- trial Registration
PACTR202002513482084
- collection
- language
- intervention Family
- Problem-solving therapy adapted for IPV.
- publication Type
- Primary intervention study
- study Family Id
- PACTR202002513482084
- family Linkage Uncertain
- false
- existing Repository Matches
- None recorded
- relevance
- relation
- direct
- population
- Pregnant women with depressive symptoms and past-year IPV.
- exposure Evidence
- Pregnant 12–34 weeks, depressive symptoms PHQ-9≥5 plus functional impact and past-year IPV by non-graphic or WHO screen; psychological/emotional IPV qualifies.
- 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 · adolescent eligibility
- reported Range
- Eligibility≥16 years; arm medians 25–25.5 years. Actual minimum/maximum and count under 18 not reported.
- youth Scope
- Adolescent eligibility is not proof of enrolled adolescent participants; no adolescent-specific outcomes.
- country
- Ethiopia
- setting
- Bu’i primary hospital and Kela health centre, rural Sodo district, Ethiopia; recruitmentApril–May 2021.
- sample Size
- randomized
- 52
- analyzed
- 39
- description
- Final 25 PST-IPV/12 standard PST/15 enhanced usual care. Only 35 entered intended three-arm allocation (25/5/5); 17 psychological/emotional-IPV women were wrongly routed to linked two-arm table. Follow-up 19/25, 8/12, 12/15.
- intervention
- description
- Four-session problem-solving therapy adapted with trauma/IPV-informed training, risk awareness and avoidance of victim blaming; sessions address participants’ chosen problems.
- dose
- Four sessions within 8 weeks; mean session durations approximately 32–51 minutes. 19/25 completed all 4; 5 attended none, 1 attended one.
- provider
- Six trained antenatal-care providers for PST-IPV, separately trained from six standard PST providers; psychiatrist/psychologist training and supervision with audio-sampled fidelity assessment.
- comparator
- Four-session standard PST (12 women) or enhanced usual care (15 women: well-being leaflet and local support information). All arms additional to routine antenatal care. Shared comparator structure with linked depression feasibility trial.
- outcomes
- name
- Implementation feasibility
- follow Up
- Recruitment 35 days; follow-up planned 9 weeks
- result
- 52 eligiblewomen enrolled; 39/52 completed assessment; delivery feasible with changes required to randomization, provider skills and scheduling.
- effect Estimate
- Not recorded
- uncertainty
- Primary aim was feasibility, not powered comparative efficacy.
- primary Status
- primary
- name
- Acceptability and delivery fidelity
- follow Up
- Four-session intervention over 8 weeks
- result
- 19/25 PST-IPV and 8/12 standard PST completed all 4 sessions. Providers sometimes ignored IPV disclosures; risk/confidentiality discussion needed improvement.
- effect Estimate
- Not recorded
- uncertainty
- IPV was infrequently discussed and then for 1–4 minutes. Completion alone does not establish competent IPV response.
- primary Status
- secondary implementation
- name
- Depressive symptoms and IPV
- follow Up
- Planned 9 weeks; 12/39 assessments occurred early
- result
- Descriptive symptoms/IPV scores fell in several arms; no powered causal comparison or effect size established.
- effect Estimate
- Follow-up medianPHQ-9: 6 PST-IPV, 6 standard PST, 4 enhanced usual care in the full sample; these are descriptive medians with unequal selected follow-up denominators.
- uncertainty
- No significant-benefit claim. IPV recall windows overlapped; misallocation confounds group comparison.
- primary Status
- pilot clinical measures
- name
- Safety
- follow Up
- During trial and births by data-collection end
- result
- One serious adverse event: assault by husband. Two obstructed/prolonged-labour complications among 29 participants who had delivered.
- effect Estimate
- Not recorded
- uncertainty
- Assault arm and relatedness to participation not reported; incomplete obstetric follow-up. Safe-delivery conclusion is not zero-harm evidence.
- primary Status
- secondary implementation
- finding
- PST-IPV was implementable with adaptations, but serious allocation errors, 25% missing follow-up and short descriptive assessment preclude an efficacy conclusion. One serious assault event was reported without arm or causal attribution.
- limitation
- Seventeen women with psychological/emotional IPV had no chance of assignment toPST-IPV; baseline imbalance suggests possible nonrandom allocation. Twelve of 39 assessments occurred before 9 weeks. Underpowered feasibility, missing follow-up, provider fidelity problems and overlapping IPV recall periods limit interpretation.
- design
- type
- Randomized controlled feasibility study with material allocation-protocol deviations
- randomization Evidence
- Independent statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- masking
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- crosses
- 1
- cross Rationale
- Random tables and controlled allocation are verified, but one third were routed through the wrong allocation scheme. Retain one design cross with this prominent qualification; no double-blind claim and no reliable efficacy inference.
- quality
- risk Of Bias
- High concern for comparative causal inference because 17/52 entered the wrong allocation table and arm-closing rules generated uneven groups; masked assessors/analysts do not repair this. No formal RoB/Jadad score.
- attrition
- 13/52 (25%)missing follow-up: 5 moved, 4 untraceable, 4 declined (often postnatal confinement). Arm follow-up 19/25, 8/12, 12/15. Nonresponders younger (median 20 vs 25.5) and apparently more trauma-symptomatic. 12/39 assessments occurred 37–61 days rather than target 63.
- confounding
- Three-arm intended sample 35 and full sample 52 are reported separately. Shared controls with linked depression trial must not be counted as independent evidence. No powered efficacy test; differences in clinical medians are not treatment effects.
- adverse Findings
- One serious adverse event was assault by husband; assignment and treatment relatedness unreported. Two obstructed/prolonged-labour complications among 29 delivered. Independent assessors found risk/confidentiality discussions needed improvement, and some providers did not respond to IPV disclosure.
- transfer Limits
- Rural Amharic-speaking pregnant women with depressive symptoms and IPV; imminent risk/psychosis/emergency care excluded. No long-term follow-up, no established adolescent subgroup effect.
- jadad
- not established
- access
- level
- full-text
- source URLs
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- sources
- url
- https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%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/37889918/
- 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
- url
- https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054
- type
- Crossref DOI registration metadata
- retrieved At
- 2026-10-30T07:20:01.507627+00:00
- identity Verified
- true
- notes
- DOI identity cross-check; metadata title: Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia. Correction/update relations checked.
- url
- https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- type
- primary-full-text
- retrieved At
- 2026-10-30T08:21:40.085701+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-article · 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. · PACTR 202002513482084 preserved. Linked standard PST/depression trial shares control structure; 35 correctly randomized versus 17 misclassified women are not separate independent experiments. · Feasibility results remain review-ready with central misallocation and SAE caveats. Assault attribution is unreported, not assumed either related or unrelated.
- review Ready
- true
- review Readiness
- ai-editorial-audit-complete-release-pending
- research Lane
- adult-therapy
- later Review Evidence
- id
- dv-adult-therapy-37889918
- title
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- prior Revision
- r1-a8b708e75848
- prior Content Hash
- a8b708e75848ba81679661cf66d65e1b1cb8bbb93e019a178f14983d0ef3604b
- original
- review Ready
- true
- review Readiness
- ready-with-access-limits
- finding
- Recruitment and attendance were feasible, but allocation fidelity and provider communication needed improvement; this was not a powered efficacy trial.
- limitation
- Small feasibility trial; cultural interpretation of IPV impeded fidelity to randomization.
- 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
- Seventeen of 52 women were routed through a wrong allocation table and could not receive PST-IPV; only 35 entered the intended three-arm process. One serious adverse event was an assault by a participant’s husband; arm and causal attribution are unreported. Follow-up was missing for 13/52 and occurred early for 12/39 respondents.
- revised Interpretation
- Treat this as feasibility learning with allocation and outcome-timing problems, not comparative efficacy. Report the assault without attributing it to the intervention or claiming absence of harm.
- required Before Approval
- Add the allocation deviation, assault and missing attribution to a new revision before approval. Arm-specific causal interpretation remains unavailable.
- source URLs
https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- source Location
- Randomisation; Protocol deviations; Feasibility; Safety; Discussion
- 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
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- source Verification
- id
- dv-adult-therapy-37889918
- doi
- 10.1371/journal.pgph.0002054
- pmid
- 37889918
- fresh Metadata
- Europe PMC core
- metadata Retrieved
- true
- metadata SHA256
- eab456b0d5f24ba0913467792baae86ab5dfb34b0ae53f13bcf97012e783d4d0
- 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:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054
- 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 statistician generated 3-arm 2: 1: 1 table; coordinator/research assistant retained tables and received calls after baseline. Enrollment in an arm closed at 25. Seventeen of 52 women misclassified as no IPV were instead allocated by linked trial’s 2-arm table, excluding their opportunity forPST-IPV; authors note possible nonrandom allocation from baseline imbalance.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/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
- Random tables and controlled allocation are verified, but one third were routed through the wrong allocation scheme. Retain one design cross with this prominent qualification; no double-blind claim and no reliable efficacy inference.
- sources
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- review Scope
- full-text
- human Approval
- false
- display Crosses
- 1
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- jadad
- status
- unassessed
- score
- Not recorded
- evidence
- population
- relation
- direct
- population
- Pregnant women with depressive symptoms and past-year IPV.
- exposure Evidence
- Pregnant 12–34 weeks, depressive symptoms PHQ-9≥5 plus functional impact and past-year IPV by non-graphic or WHO screen; psychological/emotional IPV qualifies.
- 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
- Four-session problem-solving therapy adapted with trauma/IPV-informed training, risk awareness and avoidance of victim blaming; sessions address participants’ chosen problems.
- dose
- Four sessions within 8 weeks; mean session durations approximately 32–51 minutes. 19/25 completed all 4; 5 attended none, 1 attended one.
- provider
- Six trained antenatal-care providers for PST-IPV, separately trained from six standard PST providers; psychiatrist/psychologist training and supervision with audio-sampled fidelity assessment.
- comparator
- Four-session standard PST (12 women) or enhanced usual care (15 women: well-being leaflet and local support information). All arms additional to routine antenatal care. Shared comparator structure with linked depression feasibility trial.
- outcomes
- name
- Implementation feasibility
- follow Up
- Recruitment 35 days; follow-up planned 9 weeks
- result
- 52 eligiblewomen enrolled; 39/52 completed assessment; delivery feasible with changes required to randomization, provider skills and scheduling.
- effect Estimate
- Not recorded
- uncertainty
- Primary aim was feasibility, not powered comparative efficacy.
- primary Status
- primary
- name
- Acceptability and delivery fidelity
- follow Up
- Four-session intervention over 8 weeks
- result
- 19/25 PST-IPV and 8/12 standard PST completed all 4 sessions. Providers sometimes ignored IPV disclosures; risk/confidentiality discussion needed improvement.
- effect Estimate
- Not recorded
- uncertainty
- IPV was infrequently discussed and then for 1–4 minutes. Completion alone does not establish competent IPV response.
- primary Status
- secondary implementation
- name
- Depressive symptoms and IPV
- follow Up
- Planned 9 weeks; 12/39 assessments occurred early
- result
- Descriptive symptoms/IPV scores fell in several arms; no powered causal comparison or effect size established.
- effect Estimate
- Follow-up medianPHQ-9: 6 PST-IPV, 6 standard PST, 4 enhanced usual care in the full sample; these are descriptive medians with unequal selected follow-up denominators.
- uncertainty
- No significant-benefit claim. IPV recall windows overlapped; misallocation confounds group comparison.
- primary Status
- pilot clinical measures
- name
- Safety
- follow Up
- During trial and births by data-collection end
- result
- One serious adverse event: assault by husband. Two obstructed/prolonged-labour complications among 29 participants who had delivered.
- effect Estimate
- Not recorded
- uncertainty
- Assault arm and relatedness to participation not reported; incomplete obstetric follow-up. Safe-delivery conclusion is not zero-harm evidence.
- primary Status
- secondary implementation
- access
- level
- full-text
- source URLs
https://www.ebi.ac.uk/europepmc/webservices/rest/search?query=EXT_ID:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- citation Snapshot
- count
- Not recorded
- source
- Not recorded
- retrieved At
- Not recorded
- status
- not-assessed
- provenance
- Discovered by AI
- content Hash
- 54991bc67916d3d5951f9eb1eb38c1cdb7278e19baa3e46ec94720f3dd5cbd33
- revision
- audit-r2-54991bc67916
- archive Entries
- None recorded
- collection
- language
- chapter Number
- 5
- topic Id
- domestic-family-violence
- topic Title
- Domestic & Family Violence
- trust Score
- 2
- evidence
- evidence Type
- Randomized controlled feasibility study with material allocation-protocol deviations
- intervention
- Four-session problem-solving therapy adapted with trauma/IPV-informed training, risk awareness and avoidance of victim blaming; sessions address participants’ chosen problems. Four sessions within 8 weeks; mean session durations approximately 32–51 minutes. 19/25 completed all 4; 5 attended none, 1 attended one.
- comparator
- Four-session standard PST (12 women) or enhanced usual care (15 women: well-being leaflet and local support information). All arms additional to routine antenatal care. Shared comparator structure with linked depression feasibility trial.
- sample
- Final 25 PST-IPV/12 standard PST/15 enhanced usual care. Only 35 entered intended three-arm allocation (25/5/5); 17 psychological/emotional-IPV women were wrongly routed to linked two-arm table. Follow-up 19/25, 8/12, 12/15.
- measurement
- Implementation feasibility; Acceptability and delivery fidelity; Depressive symptoms and IPV; Safety
- timing
- Recruitment 35 days; follow-up planned 9 weeks; Four-session intervention over 8 weeks; Planned 9 weeks; 12/39 assessments occurred early; During trial and births by data-collection end
- trial Id
- PACTR202002513482084
- 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:37889918%20AND%20SRC:MED&format=json&resultType=core · https://api.crossref.org/works/10.1371%2Fjournal.pgph.0002054 · https://www.ebi.ac.uk/europepmc/webservices/rest/PMC10610520/fullTextXML
- retrieved At
- 2026-10-30T08:21:40.085701+00:00
- outcomes
- name
- Implementation feasibility
- follow Up
- Recruitment 35 days; follow-up planned 9 weeks
- result
- 52 eligiblewomen enrolled; 39/52 completed assessment; delivery feasible with changes required to randomization, provider skills and scheduling.
- effect Estimate
- Not recorded
- uncertainty
- Primary aim was feasibility, not powered comparative efficacy.
- primary Status
- primary
- name
- Acceptability and delivery fidelity
- follow Up
- Four-session intervention over 8 weeks
- result
- 19/25 PST-IPV and 8/12 standard PST completed all 4 sessions. Providers sometimes ignored IPV disclosures; risk/confidentiality discussion needed improvement.
- effect Estimate
- Not recorded
- uncertainty
- IPV was infrequently discussed and then for 1–4 minutes. Completion alone does not establish competent IPV response.
- primary Status
- secondary implementation
- name
- Depressive symptoms and IPV
- follow Up
- Planned 9 weeks; 12/39 assessments occurred early
- result
- Descriptive symptoms/IPV scores fell in several arms; no powered causal comparison or effect size established.
- effect Estimate
- Follow-up medianPHQ-9: 6 PST-IPV, 6 standard PST, 4 enhanced usual care in the full sample; these are descriptive medians with unequal selected follow-up denominators.
- uncertainty
- No significant-benefit claim. IPV recall windows overlapped; misallocation confounds group comparison.
- primary Status
- pilot clinical measures
- name
- Safety
- follow Up
- During trial and births by data-collection end
- result
- One serious adverse event: assault by husband. Two obstructed/prolonged-labour complications among 29 participants who had delivered.
- effect Estimate
- Not recorded
- uncertainty
- Assault arm and relatedness to participation not reported; incomplete obstetric follow-up. Safe-delivery conclusion is not zero-harm evidence.
- primary Status
- secondary implementation
- quality
- risk Of Bias
- High concern for comparative causal inference because 17/52 entered the wrong allocation table and arm-closing rules generated uneven groups; masked assessors/analysts do not repair this. No formal RoB/Jadad score.
- attrition
- 13/52 (25%)missing follow-up: 5 moved, 4 untraceable, 4 declined (often postnatal confinement). Arm follow-up 19/25, 8/12, 12/15. Nonresponders younger (median 20 vs 25.5) and apparently more trauma-symptomatic. 12/39 assessments occurred 37–61 days rather than target 63.
- confounding
- Three-arm intended sample 35 and full sample 52 are reported separately. Shared controls with linked depression trial must not be counted as independent evidence. No powered efficacy test; differences in clinical medians are not treatment effects.
- adverse Findings
- One serious adverse event was assault by husband; assignment and treatment relatedness unreported. Two obstructed/prolonged-labour complications among 29 delivered. Independent assessors found risk/confidentiality discussions needed improvement, and some providers did not respond to IPV disclosure.
- transfer Limits
- Rural Amharic-speaking pregnant women with depressive symptoms and IPV; imminent risk/psychosis/emergency care excluded. No long-term follow-up, no established adolescent subgroup effect.
- jadad
- not established
- masking Roles
- participants
- No participant masking procedure established; active sessions versus leaflet care differ.
- providers
- Explicitly unmasked; separate provider groups trained for each active intervention.
- assessors
- Independent collectors exchanged recruitment sites for follow-up and were masked, with unmasking incidents to be documented; no incident count reported.
- analysts
- Explicitly masked to allocation.
- population
- relation
- direct
- population
- Pregnant women with depressive symptoms and past-year IPV.
- exposure Evidence
- Pregnant 12–34 weeks, depressive symptoms PHQ-9≥5 plus functional impact and past-year IPV by non-graphic or WHO screen; psychological/emotional IPV qualifies.
- 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.
- jadad
- status
- unassessed
- score
- Not recorded
- condition Evidence
- id
- depression
- evidence
- field
- title
- text
- Problem-solving therapy for pregnant women experiencing depressive symptoms and intimate partner violence: A randomised, controlled feasibility trial in rural Ethiopia.
- matched Text
- depressive
- field
- population
- text
- Pregnant women with depressive symptoms and past-year IPV.
- matched Text
- depressive
- field
- outcomes
- text
- Implementation feasibility | Acceptability and delivery fidelity | Depressive symptoms and IPV | Safety
- matched Text
- Depressive
- scope
- Study population or investigated outcome; not a diagnosis or efficacy claim.
- conditions
depression
- topic Trust Scores
2
- full Text
- status
- not-indexed
- retrieval Available
- false