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

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.

NCT Number	NCT06834867
Lead Sponsor	Possible Collaborators: University of California, San Francisco, National Institute of Mental Health (NIMH), Wheaton College, Women's Rehabilitation Centre (WOREC)
Conditions	Intimate Partner Violence (IPV), Depression, PTSD - Post Traumatic Stress Disorder
Enrollment	900 participants
Start Date	2025-04-04
Primary Completion	2027-01-29 (estimated)
Study Completion	2028-04-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-14