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Recruiting NCT05893277

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

Trial Parameters

Condition Intimate Partner Violence
Sponsor University of California, San Francisco
Study Type INTERVENTIONAL
Phase N/A
Enrollment 800
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-10-12
Completion 2027-05-31
Interventions
Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT)

Brief Summary

The goal of this randomized clinical trial is to test an intervention consisting of a combination of behavioral couples therapy and motivational interviewing to improve communication and reduce conflicts between couples and decrease harmful drinking among spouses in urban primary health centers, South India. The intervention will be delivered by nurses in primary health centers who will be supervised by a clinical psychologist. The main question\[s\] it aims to answer are: * Do the wives of the couples in the intervention report less intimate partner violence (IPV) after 12 months, compared to wives in couples in a control group? * Do the husbands of the couples in the intervention show less alcohol consumption after 12 months, compared to husbands in couples in a control group? Husbands will participate in Motivational Interview (MI) sessions targeted at reducing their alcohol use. Husband and wife will participate in Behavioral Couples Therapy (BCT) targeted at improving their marital relationship. These intervention participants will be compared to a control group who will receive only referral information for intimate partner violence and an educational session and referral for alcohol use disorder. All participants will participate in quantitative interviews at baseline, and every three months thereafter, for a period of one year. In-depth qualitative interviews will be done with a subgroup of couples to try to understand how the intervention led to the observed outcomes.

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

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