NCT06834867: MILAP

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

Recruiting now NA Last updated 14 April 2026

What this trial tests

NA trial testing MILAP intervention in Intimate Partner Violence (IPV) in 900 participants. Currently enrolling.

Timeline

4 April 2025

Primary endpoint
29 January 2027

1 April 2028

Quick facts

Lead sponsor	Possible
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	900
Start date	4 April 2025
Primary completion	29 January 2027
Estimated completion	1 April 2028
Sites	1 location across Nepal

Drugs / interventions tested

• MILAP intervention

Conditions studied

• Intimate Partner Violence (IPV) — all drugs for Intimate Partner Violence (IPV) →
• Depression — all drugs for Depression →
• PTSD - Post Traumatic Stress Disorder — all drugs for PTSD - Post Traumatic Stress Disorder →

Sponsor

Possible

Who can join

Adults 15 to 24, any sex, with Intimate Partner Violence (IPV) or Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Shrestha M, Heylen E, Sigdel K, Dhimal M, et al · · 2026 · PMID 41680806 · DOI 10.1186/s13063-026-09507-8
2. 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
   Shrestha M, Heylen E, Sigdel K, Dhimal M, et al · · 2025 · DOI 10.21203/rs.3.rs-7048952/v1