Feasibility and Effectiveness of an Intervention to Reduce Intimate Partner Violence and Psychological Distress Among Women in Nepal: Protocol for the Domestic Violence Intervention (DeVI) Cluster-Randomized Trial
Authors: Shrestha Rachana , Sapkota Diksha , Mehra Devika , Ekström Anna Mia , Deuba Keshab 
Published: August 2023

Background
Intimate partner violence (IPV) disproportionately affects people in low-and middle-income countries (LMICs), such as Nepal. Women experiencing IPV are at higher risk of developing depression, anxiety, and posttraumatic stress disorder. The shortage of trained frontline health care providers, coupled with stigma related to IPV and mental health disorders, fuels low service uptake among women experiencing IPV. The Domestic Violence Intervention (DeVI) combines the Problem Management Plus counseling program developed by the World Health Organization with a violence prevention component.

Objective
This study aims to implement and evaluate the feasibility, acceptability, and effectiveness of DeVI in addressing psychological distress and enabling the secondary prevention of violence for women experiencing IPV.

Methods
A parallel cluster-randomized trial will be conducted across 8 districts in Madhesh Province in Nepal, involving 24 health care facilities. The study will include women aged 18-49 years who are either nonpregnant or in their first trimester, have experienced IPV within the past 12 months, have a 12-item General Health Questionnaire (GHQ-12) score of 3 or more (indicating current mental health issues), and have lived with their husbands or in-laws for at least 6 months. A total sample size of 912 was estimated at 80% power and α<.05 statistical significance level to detect a 15% absolute risk reduction in the IPV frequency and a 50% reduction in the GHQ-12 score in the intervention arm. The health care facilities will be randomly assigned to either the intervention or the control arm in a 1:1 ratio. Women visiting the health care facilities in the intervention and control arms will be recruited into the respective arms. In total, 38 participants from each health care facility will be included in the trial to meet the desired sample size. Eligible participants allocated to either arm will be assessed at baseline and follow-up visits after 6, 17, and 52 weeks after baseline.

Results
This study received funding in 2019. As of December 29, 2022, over 50% of eligible women had been recruited from both intervention and control sites. In total, 269 eligible women have been enrolled in the intervention arm and 309 eligible women in the control arm. The trial is currently in the recruitment phase. Data collection is expected to be completed by December 2023, after which data analysis will begin.

Conclusions
If the intervention proves effective, it will provide evidence of how nonspecialist mental health care providers can address the harmful effects of IPV in resource-constrained settings with a high burden of IPV, such as Nepal. The study findings could also contribute evidence for integrating similar services into routine health programs in LMICs to prevent IPV and manage mental health problems among women experiencing IPV.

Trial Registration
ClinicalTrials.gov NCT05426863; https://clinicaltrials.gov/ct2/show/NCT05426863

International Registered Report Identifier (IRRID)
DERR1-10.2196/45917