Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence in Nepal

NCT06834867 | Recruiting DMC

• 2 other identifiers: MILAPPossible1R01MH135376-01
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Intimate Partner Violence (IPV) is a major public health problem in low- and middle-income countries (LMICs). Globally, an estimated 30% of women report physical or sexual violence by an intimate partner in their lifetime. IPV is a well-established social driver of mental health problems, and doubles the rate of depression and post-traumatic stress disorder (PTSD). Interventions like cognitive behavioral therapy (CBT) can improve depression after women experiencing IPV exit abusive relationships. However, despite ongoing violence, many young women in LMICs are less likely to divorce or separate from their husband. But ongoing IPV severely limits mental health recovery and increases the risks of suicide. Another important factor in many LMICs is that young women often live in extended, multi-generational households, where studies have shown that mother-in-laws (MILs) play a critical role in young married women's autonomy and freedom of movement, substantially affecting her mental health. The pathways via which multiple family members and ongoing IPV affect young women's mental health in LMICs is very poorly understood. There is an urgent need to design and assess interventions that: a) improve mental health and reduce IPV; b) engage husbands and MILs, and not just women experiencing IPV; and c) elucidate pathways via which IPV-related drivers affect mental health. This study's research team, with over 16 years of experience in Nepal, conducted a pilot study introducing the Multi-component family Intervention to Lower depression and Address intimate Partner violence (MILAP). MILAP, which translates to "unity and reconciliation" in Nepali, showed promise in reducing depression and IPV among families (comprising women, husbands, and mothers-in-law). Based on these favorable results, the investigators now propose a 12-month randomized controlled trial (RCT) to assess the effectiveness of MILAP in addressing depression, IPV, and PTSD among young married women in Nepal. The goal of this RCT is to assess the effectiveness of MILAP, understand mechanisms of change for MILAP's effectiveness, and conduct a cost-effectiveness analysis. The specific aims of this study are: AIM 1: Conduct a 12-month RCT to assess the effectiveness of MILAP on depression, IPV, and PTSD among young married women in Nepal. AIM 2: Conduct a mixed-methods assessment of theorized mechanisms of change for MILAP's effectiveness. AIM 3: Conduct a cost-effectiveness analysis of MILAP for depression and IPV. Participants of this study will receive either MILAP or enhanced usual care, and will answer questions about depression, IPV and PTSD at baseline, at 1 month and every 3 months until 1-year.

Conditions

Intimate Partner Violence (IPV); Depression; PTSD - Post Traumatic Stress Disorder

Keywords

Intimate Partner Violence; Depression; Family Intervention; Mental Health; Nepal; MILAP

Outcome Measures

Primary Outcomes (2)

• Proportion of women who have moderate to severe depression

  Patient Health Questionnaire (PHQ-9) is a widely used instrument for screening, diagnosing, and monitoring the severity of depression. It consists of 9 items, each scored from 0 (not at all) to 3 (nearly every day), with a total possible score ranging from 0 to 27. Higher scores reflect greater severity of depressive symptoms, making the PHQ-9 a valuable tool for assessing the impact of interventions on depression levels. This study will use PHQ-9 score as continuous variable and assess proportion of women whose PHQ-9 score is greater than 9 at 12-month follow-up

  Assessments at baseline, and at 1, 3, 6, 9 and 12 months follow-ups.

• Abusive control, physical violence, and sexual violence/coercion

  This study will measure abusive control, physical violence, and sexual violence/coercion using the Indian Family Violence and Control Scale (IFVCS), which is specifically designed to assess and quantify various forms of violence and controlling behaviors within family contexts. It includes 75 items on physical, emotional, and financial abuse, along with behaviors aimed at exerting control, particularly within marital relationships. This study will use 63 items, out of total 75 items, that are relevant to the study outcomes. Higher score explains high control and violence over women. The score ranges from 14 to 56.

  Assessment at baseline, and at 1, 3, 6, 9, and 12 months follow-ups

Secondary Outcomes (1)

• Post-traumatic Stress Disorder (PTSD) Symptom Severity

  Assessments at baseline, and at 1, 3, 6, 9, and 12 months follow-ups.

Study Arms (2)

Enhanced Usual Care

NO INTERVENTION

The control arm will receive enhanced usual care. Counselors (who will be trained by the research team) of the Women's Rehabilitation Centre (WOREC) will conduct initial safety assessment for all participants and offer: a) WOREC's IPV rehabilitation service, which includes a women's shelter, safety and protection from the perpetrator, MH counseling, legal support, and health services; b) educational materials on safety, problems caused by continued IPV, written resources for reducing IPV, and an IPV/DV nationwide hotline; c) referral to wraparound services depending on the woman's needs and priorities: legal support, safe house, psychosocial counseling, health services, and livelihood support services; d) refer to the Nepali government's one-stop IPV center at Janakpur Provincial Hospital and Koshi Hospital in Nepal, and inform them of their options (including support for leaving the relationship if they express that wish).

MILAP Intervention

EXPERIMENTAL

The MILAP intervention, developed through participatory research and two phases of pilot studies, includes 9 sessions over 9 weeks, totaling 11 hours. MILAP will start with the MilDil component, consisting of two weekly sessions (4 hours total) for mother-in-law (MIL) and daughter-in-law (DIL) dyads, focusing on discussing cultural gender norms and establishing allyship between MIL and DIL. These sessions will be followed by two one-hour sessions on brief Behavioral Activation (BA) to address and prevent depression. After the completion of the MilDil component, the husband-wife dyad will engage in four weekly sessions (4 hours) of Behavioral Couples Therapy (BCT), aimed at improving communication, establishing safety and trust, coping strategies, and fostering caring behaviors between partners. The ninth session (1 hour) will include the triad (woman, husband, and MIL) to review all the lessons learned in the full MILAP intervention, and prepare them to address any challenges.

Behavioral: MILAP intervention

Interventions

MILAP intervention BEHAVIORAL

The MILAP intervention, developed through participatory research, includes 9 sessions over 9 weeks, totaling 11 hours. It begins with the MilDil component, consisting of two sessions (4 hours) for MIL-DIL dyads, focusing on discussing cultural gender norms, raising awareness about the negative impact of IPV, establishing allyship between MIL and DIL, and empowering DILs while enhancing MILs' support for DILs' freedom of movement. This is followed by two one-hour sessions on Brief Behavioral Activation (BA) to address and prevent depression, involving MILs for necessary family support. Lastly, the husband-wife dyad will engage in four weekly sessions (4 hours) of Behavioral Couples Therapy (BCT), aimed at improving communication, coping strategies, and fostering caring behaviors between partners.

MILAP Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Married women aged 15-24 years, their husbands and MILs sharing a household;
• Living in the catchment area with no stated intention of leaving during the study period;
• Participants speaking in Maithili or Nepali;
• Wife reporting Intimate Partner Violence (physical, sexual or abusive control) in last 12 months as measured by three questions from the International Violence Against Women Survey (IVAWS);
• Expressing desire to remain in the current relationship/family

You may not qualify if:

• Pregnant women;
• History of IPV severe enough to result in hospitalization in the past 12 months;
• Significant cognitive problems/disability precluding participation;
• Any participant with Severe Alcohol Dependence, defined as Severity of Alcohol Dependence Questionnaire (SADQ) \> 31 (those with mild to moderate dependance will be referred but not excluded)

Sponsors & Collaborators

• Possible: lead
• University of California, San Francisco: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Wheaton College: collaborator
• Women's Rehabilitation Centre (WOREC): collaborator

Study Sites (1)

Possible

Kathmandu, Bagmati, Nepal

RECRUITING

Related Publications (7)

• Sapkota D, Baird K, Saito A, Anderson D. Interventions for reducing and/or controlling domestic violence among pregnant women in low- and middle-income countries: a systematic review. Syst Rev. 2019 Apr 2;8(1):79. doi: 10.1186/s13643-019-0998-4.

  PMID: 30940204 BACKGROUND

• Bean J, Moller AT. Posttraumatic stress and depressive symptomatology in a sample of battered women from South Africa. Psychol Rep. 2002 Jun;90(3 Pt 1):750-2. doi: 10.2466/pr0.2002.90.3.750.

  PMID: 12090502 BACKGROUND

• Marahatta K, Samuel R, Sharma P, Dixit L, Shrestha BR. Suicide burden and prevention in Nepal: The need for a national strategy. WHO South East Asia J Public Health. 2017 Apr;6(1):45-49. doi: 10.4103/2224-3151.206164.

  PMID: 28597859 BACKGROUND

• Rimal P, Choudhury N, Agrawal P, Basnet M, Bohara B, Citrin D, Dhungana SK, Gauchan B, Gupta P, Gupta TK, Halliday S, Kadayat B, Mahar R, Maru D, Nguyen V, Poudel S, Raut A, Rawal J, Sapkota S, Schwarz D, Schwarz R, Shrestha S, Swar S, Thapa A, Thapa P, White R, Acharya B. Collaborative care model for depression in rural Nepal: a mixed-methods implementation research study. BMJ Open. 2021 Aug 16;11(8):e048481. doi: 10.1136/bmjopen-2020-048481.

  PMID: 34400456 BACKGROUND

• Patel AR, Prabhu S, Sciarrino NA, Presseau C, Smith NB, Rozek DC. Gender-based violence and suicidal ideation among Indian women from slums: An examination of direct and indirect effects of depression, anxiety, and PTSD symptoms. Psychol Trauma. 2021 Sep;13(6):694-702. doi: 10.1037/tra0000998. Epub 2021 Jan 28.

  PMID: 33507794 BACKGROUND

• Shrestha M, Heylen E, Sigdel K, Dhimal M, Nepal P, Pant P, Jha RK, Rimal R, Khatri R, Joshi S, Sharma S, Shrestha S, Poudel S, Mainali S, Sapkota S, Acharya B. A multi-component family intervention to lower depression and address intimate partner violence (MILAP) among young married women in Nepal: a study protocol for a randomized controlled trial. Trials. 2026 Feb 12. doi: 10.1186/s13063-026-09507-8. Online ahead of print.

  PMID: 41680806 DERIVED

• Shrestha M, Heylen E, Sigdel K, Dhimal M, Nepal P, Pant P, Jha RK, Rimal R, Khatri R, Joshi S, Sharma S, Shrestha S, Poudel S, Mainali S, Sapkota S, Acharya B. A randomized controlled trial of a multi-component family intervention to lower depression and address intimate partner violence (MILAP) among young married women in Nepal: a study protocol. Res Sq [Preprint]. 2025 Sep 9:rs.3.rs-7048952. doi: 10.21203/rs.3.rs-7048952/v1.

  PMID: 40964025 DERIVED

MeSH Terms

Conditions

Depression; Combat Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Personal Satisfaction

Study Officials

• Bibhav Acharya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Sabitri Sapkota, PhD

  Possible

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bibhav Acharya, MD

CONTACT

+1 917 653 9385; Bibhav.Acharya@ucsf.edu

Sabitri Sapkota, PhD

CONTACT

+977 9851031363; sabitri.sapkota@possiblehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research outcome assessors responsible for collecting data from the study participants will be blinded to the allocation status (intervention vs. enhanced usual care) of each participant. This prevents their assessments from being influenced by any potential bias they might hold regarding the effectiveness of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a randomized controlled trial (RCT) with a parallel assignment model. A total of 300 triads (n=900), each consisting of a woman, her husband, and her mother-in-law (MIL), will be randomly assigned in a 1:1 ratio to either the control group (n=150 triads) or the intervention group (n=150 triads). Note: We have not seen better option than this one in the drop down menu above.

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: April 4, 2025
• Primary Completion (Estimated): January 29, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: IPD and supporting information will be available approximately 12 months following the end of the trial (April 1, 2030). IPD will be available to the research community in perpetuity.
• Access Criteria: All shared data will be publicly accessible in the National Institute of Mental Health (NIMH) Data Archive (NDA).

Locations

NE (1)