An interventional study of Multi-component family intervention in Domestic Violence and Mental Health, sponsored by Possible. Completed at 1 site in Nepal. Open to participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Possible · Not applicable, Interventional, and Supportive care
Domestic Violence (DV) is a major public health problem in low- and middle-income countries (LMICs) including Nepal, where women often live in extended, multigenerational households, and violence can be perpetrated by the husband and/or mother-in-law (MIL). DV is a well-established social driver of mental illness and doubles the rate of depression and Post Traumatic Stress Disorders (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression among women after they exit abusive relationships with DV. However, despite ongoing violence, many young women in LMICs including Nepal are less likely to divorce or separate from their husband. But, ongoing DV severely limits mental health recovery and increases the risks of suicide. This created a need for intervention which improves mental health and reduce ongoing DV, while involving the woman along with her husband and MIL. The study team thus developed a multi-component family intervention and conducted a study to to assess the acceptability, feasibility, and preliminary efficacy of the intervention to reduce domestic violence and consequent depression among married women in Nepal.
The study was conducted with an objective to test a family intervention that engages three key family members (Woman, mother-in-law (MIL) and husband) to improve mental health while simultaneously reducing DV. The study team assessed the acceptability, feasibility, and preliminary efficacy of the intervention to reduce domestic violence and depression among married women. The study was conducted in collaboration with Women's Rehabilitation Center (WOREC), a national non-profit, community-based organization working on violence against women and children for more than two decades.
This study, was implemented in two phases. The first phase was conducted among young married women, aged 15-24 years at Dhanusa district of Madhesh Province in Nepal. After incorporating the learnings from this phase, the study team then conducted the second phase of the study with married women of reproductive age group at Dhanusa (Madhesh Province) and Morang (Koshi Province) districts.
For both phases, a single-arm intervention study was conducted, where all participants were provided with family intervention. The multi-component (MIL-DIL and BCT) family intervention engaged women, their husbands and MILs. The intervention comprises nine sessions with 11 hours total over 9 weeks. The first four sessions included the MIL-DIL sessions focused on skills building, enhancing connections with important relationships, and promoting resilience and empowerment. After MIL-DIL, the participants were provided with BCT sessions which concentrated on improving spousal relationships, fostering increased trust and caring behaviors between woman and her husband. The BCT sessions lasted for four weeks (each session lasting an hour). Finally, the participants participated in one hour triad session. This session reviewed key lessons from all previous sessions and prepared participants to address potential challenges in sustaining improvements in IPV and mental health.
To assess the feasibility and acceptability of the proposed interventions, the study used mixed-method (Quantitative + Qualitative) research design. The sampling unit was individual participant and the primary outcome of interest was depression. The study team used convenience sampling for quantitative component of the survey in both phases. The study adopted referral-based recruitment where social mobilizers, psychosocial counselors and WOREC program team who came into contact with potential research participants referred the women to the study team. The women were then screened using a screening tool following the clearly outlined screening process. The total sample size for the overall study was 258 participants (86 families), including both phases.
The quantitative data collection included administering of 17 pre-validated tools during first phase and 12 pre-validated tools during second phase which were administered at baseline (prior to intervention session), one month, three month and six month from the baseline assessment. The tools included:
For qualitative data collection, the team conducted serial in-depth interviews (IDIs) with 6-8 families in each phases (women, husband and MIL that gave us a total of 36-48 IDIs) who received MIL-DIL and BCT interventions, including both phases. The study team used purposive sampling (based on age, experience of violence, ethnicity) to select IDI participants from a subset of participants who participated in the quantitative component
Data Analysis Plan : Data from questionnaires and intervention fidelity assessments were collected and entered by trained staff on tablets that are password-protected and encrypted and securely transferred into a secure, password-protected REDCap data collection system. The study coordinators conducted weekly quality control checks under the supervision of the senior statistician to minimize data collection errors. IDIs were audio-recorded, with "debriefing" reports completed immediately after each interview and rapidly disseminated to the study team to highlight preliminary findings and emergent themes. Key findings were also captured in a results matrix that were updated from the debriefing reports. Recorded interviews were translated and transcribed at Possible in Nepal. All data were backed up on a separate password protected server. Our study coordinator reviewed debriefing reports and transcripts for quality control, with queries resolved on a weekly basis. Preliminary efficacy of the intervention for the primary outcome of women's depression was assessed by looking at the PHQ-9 score at baseline and comparing that with a 6-month follow-up. The study hypothesized that DILs had a PHQ-9 score less than 9 (mild depression) at 6-month follow-up than at the baseline. For the secondary outcomes of DV and PTSD, the study team compared the mean IFVCS and adapted CTS-2 tool and PCL-5 scores, respectively, between the baseline and six month follow-up, and expect the women in at 6-month follow-up report lower mean scores on both. The data analyst primarily conducted descriptive analysis. Besides, the data analyst also ran unadjusted analyses via t-test, as well as logistic regression and multiple linear regression models to look at the preliminary efficacy. Due to the small sample size, significance testing was de-emphasized. Acceptability was assessed among all participants using 5-point Likert scale ratings on the overall experience, self-efficacy, usefulness, and difficulties in engaging with the intervention, based on a scale in our current study. The qualitative team obtained additional insights on intervention acceptability to provide complementarity (e.g., "are there additional ideas on acceptability of the intervention that were not covered by the surveys?") and expansion (e.g., "why do you think participants gave this average score to the question about overall usefulness of the intervention?"). Feasibility were determined by: a) tracking number screened, eligible, and consenting; b) retaining > 80% of participants; c) completing > 90% assessments; and d) participants attending > 85% of intervention components as scheduled. In addition, during the IDIs, participants were asked about feasibility, barriers, and ease in engaging with the intervention.
Analyses of the IDI transcripts- The qualitative team used a thematic approach to coding and summarization using Dedoose qualitative analysis software. A preliminary codebook was developed from interview guides and rapid analysis content, then refined after all analysts code a set of transcripts independently and resolve discrepancies through consensus. The remaining transcripts were single-coded, maintaining intercoder reliability of at least 80% throughout the coding process using coding test features of Dedoose and subsequent kappa calculations. Analysts also reviewed and analyzed coded serial IDI content within each participant's dataset to look specifically for patterns over time to further understand the change process.
Triangulation of quantitative and qualitative data: Findings from the qualitative and quantitative analyses were triangulated to build a more comprehensive understanding of feasibility, acceptability and preliminary efficacy their relative weight in creating changes from baseline to 6-month follow-up. Both differences and similarities in the data sets were examined and presented to understand the relationship between the constructs in the conceptual model and to highlight any factors that may be uniquely identified by qualitative or quantitative methods. These data informed interpretation of the effectiveness findings and next steps for any refinements that may be necessary as the intervention is tested in a well-powered study.
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This study's enrollment of 258 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
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This single-arm study included one arm in which all enrolled participants received the multi-component family intervention. The intervention engaged three family members: the female participant, her husband, and her mother-in-law (MIL). During the first four weeks, the female and MIL participants participated in MIL-DIL sessions to bring them together to build allyship. Over the following four weeks, the husband-wife dyad participated in Behavioral Couples Therapy (BCT) sessions. Finally, the intervention concluded with a joint triad summary session with all three participants.
Behavioral: Multi-component family intervention
The intervention started with MIL-DIL sessions and included first two sessions (four total hours) grounded in participatory learning and action principles using stories, role-plays, and discussions to enhance knowledge, skills, and social support. These sessions prepared participants for subsequent two one-hour sessions on brief behavioral activation, an evidence-based technique for addressing and preventing depression. After completion of the MIL-DIL sessions, the husband-wife dyad received four weekly sessions of behavioral couples therapy (BCT) (four total hours). BCT sessions concentrated on improving spousal relationships, and fostering increased trust and caring behaviors between couples. The sessions also included culturally tailored deep meditation and relaxation techniques. The intervention concluded with a final triad session (an hour) which involved the woman, her husband and MIL, and gave them opportunity to reflect on the intervention and review overall lessons learnt.
Also known as: Family intervention
Change in depression score among women
Depression was assessed using the 9-item Patient Health Questionnaire (PHQ-9), which is validated in Nepal. The study team administered PHQ-9 to women participants experiencing IPV, and classified depression levels into two categories: (i) \>9 indicating moderate to severe depression, and (ii) ≤9 indicating minimal to mild symptoms. To evaluate change, the study team compared the proportion of women with moderate to severe depression at baseline versus six-month follow-up.
Time frame: First in baseline, then followed by one month, three month and six months from baseline.
Change in incidence of violence among women
Secondary outcome included change of incidence of violence among women assessed using a 63-item Indian Family Violence Control Scale (IFVCS) and an adapted 12-item Conflict Tactics Scale (CTS) -2. The IFVCS incorporates four subscales: Control (items 1-14), Psychological (items 15-36), Physical (items 37-52), and Sexual (items 53-63). The study team applied a past-month reference period to the violence subscales, while using no time reference for the Control subscale. While the IFVCS assessed violence from husbands and extended family members, the CTS-2 targeted husband-perpetrated violence exclusively.
Time frame: First in baseline, then followed by one month, three month and six months from baseline.
Plan to share: Yes — The study team will share de-identified quantitative data collected using our quantitative tools, relevant to our study . For qualitative data, the study team will share the structured notes.
Supporting information: Statistical analysis plan, Analytic code
Time frame: IPD and supporting information will be available approximately 12 months following the end of the trial. IPD will be available to the research community in perpetuity.
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Feb 2024, 23 months.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 23 months is above that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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