A Randomized Controlled Trial of a Multi-component Family Intervention to Lower Depression and Address Intimate Partner Violence (MILAP) Among Young Women in Nepal

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 24
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Nepal
Possible
RECRUITING
Kathmandu
Contact Information
Primary
Bibhav Acharya, MD
Bibhav.Acharya@ucsf.edu
+1 917 653 9385
Backup
Sabitri Sapkota, PhD
sabitri.sapkota@possiblehealth.org
+977 9851031363
Time Frame
Start Date: 2025-04-04
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 900
Treatments
No_intervention: Enhanced Usual Care
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).
Experimental: MILAP Intervention
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.
Related Therapeutic Areas
Sponsors
Leads: Possible
Collaborators: Wheaton College, National Institute of Mental Health (NIMH), Women's Rehabilitation Centre (WOREC), University of California, San Francisco

This content was sourced from clinicaltrials.gov