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Search / Trial NCT05893277

Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · May 30, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Randomized Controlled Trial Motivational Interviewing Behavioral Couples Therapy India Nurse Delivered Intervention

ClinConnect Summary

The Harmony trial is studying a new approach to help couples in South India who are facing problems related to intimate partner violence and alcohol use. The trial combines two methods: Behavioral Couples Therapy (BCT), which helps couples communicate better and resolve conflicts, and Motivational Interviewing (MI), which encourages husbands to reduce their drinking. This program will be led by trained nurses at local health centers, with support from a clinical psychologist. The main goal is to see if wives in the program experience less intimate partner violence and if husbands drink less after a year compared to couples who are only given general information about these issues.

To participate in the trial, couples need to meet certain criteria: both partners must be at least 18 years old, speak Kannada or Hindi, and the wife must have experienced any form of intimate partner violence in the past year. Additionally, the husband should have a drinking problem, as determined by a specific screening tool. Throughout the year, couples will answer questionnaires every three months, and some will take part in deeper interviews to help researchers understand how the program works. This trial is currently recruiting participants, and it represents an important effort to improve the well-being of families dealing with these challenging issues.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. married couple with both spouses age ≥18;
  • 2. living within the catchment area of the PHC (primary health center);
  • 3. speaking Kannada or Hindi;
  • 4. wife reporting any physical or sexual intimate partner violence (IPV) in the past 12 months (note exclusion for severe IPV below);
  • 5. the husband having Alcohol Use Disorder (AUD) measured by AUDIT-C (AUDIT-C ≥4).
  • Exclusion Criteria:
  • 1. husband has severe alcohol dependency (per Severity of Alcohol Dependence Questionnaire, SADQ ≥ 31) or is at risk of severe withdrawal symptoms (Clinical Institute Withdrawal Assessment for Alcohol Scale-Revised - CIWA-AR);
  • 2. significant medical problems that will make the couple unable to participate in the intervention sessions;
  • 3. cognitive problems (adapted Short-Blessed Cognitive Test score ≤7);
  • 4. past year history of IPV severe enough to result in hospitalization (per an adapted version of the International Violence Against Women Survey - IVAWS), or 5) wife screens positive for any AUD (AUDIT-C \>4).

About University Of California, San Francisco

The University of California, San Francisco (UCSF) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on translating scientific discoveries into effective therapies, UCSF collaborates with a diverse array of stakeholders, including healthcare professionals, industry partners, and patient communities. The university's research programs emphasize interdisciplinary approaches and leverage cutting-edge technology to address complex medical challenges. As a sponsor of clinical trials, UCSF is dedicated to maintaining the highest standards of ethical conduct and scientific rigor, ensuring the safety and well-being of participants while contributing to the broader medical knowledge base.

Locations

Bangalore, Karnataka, India

Patients applied

0 patients applied

Trial Officials

Maria L Ekstrand, PhD

Principal Investigator

University of California, San Francisco

Bibhav Acharya, MD

Principal Investigator

University of California, San Francisco

Krisnamachari Srinivasan, MD

Principal Investigator

St John's Research Institute, Bengaluru India

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported