Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India
NCT05893277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2025-07-04
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.
Conditions
- Intimate Partner Violence
- Alcohol Use Disorder
Interventions
- BEHAVIORAL
-
Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT)
Four Motivational Interviewing sessions with the husband (wife joins for last MI session) to reduce alcohol use dependency, followed by six Behavioral Couples Therapy session with the husband and wife together to improve their relation and communication and reduce intimate partner violence. Session 1: couple establishes daily trust contract and discusses strategies to cope with reduced alcohol use. Session 2: couple revisits these coping skills and builds on additional strategies, as necessary. Session 3: they shift to improving the relationship and communication. Session 4: activity to promote caring behavior between partners. Session 5: couple reviews communication strategies learned previously, learn active listening and address any ongoing communication challenges. Session 6: review session and plans to address challenges to create long-term change.
Sponsors & Collaborators
-
St. John's Research Institute
collaborator OTHER -
RTI International
collaborator OTHER -
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Maria L Ekstrand, PhD · University of California, San Francisco
-
Bibhav Acharya, MD · University of California, San Francisco
-
Krisnamachari Srinivasan, MD · St John's Research Institute, Bengaluru India
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-12
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- India
Study Locations
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