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

NCT05893277 | Recruiting DMC

• 1 other identifier: R01AA029303
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Intimate Partner Violence; Alcohol Use Disorder

Keywords

Randomized Controlled Trial; Motivational Interviewing; Behavioral Couples Therapy; India; Nurse-delivered intervention

Outcome Measures

Primary Outcomes (8)

• Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

  The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

  baseline

• Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

  The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

  6 months post baseline

• Intimate Partner Violence: mean score on Indian Family Violence and Control Scale

  The Indian Family Violence and Control Scale (IFVCS) will be administered to the wife only. The IFVCS is a 63-item scale measuring self-reported frequency of occurrence of control and psychological, physical, and sexual violence in the past year. The mean score ranges from 0 to 3 with higher scores indicating experience of more or more frequent intimate partner violence.

  12 months post baseline

• Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

  Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

  baseline

• Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

  Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

  3 months post baseline

• Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

  Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

  6 months post baseline

• Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

  Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

  9 months post baseline

• Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score

  Self-assessed alcohol use dependency (husband only) will be measured using the 10-item Alcohol Use Disorders Identification Test (AUDIT). Each items is scored on a 0-4 scale and items scores are summed, resulting in a range from 0 to 40, with higher scores indicating greater alcohol use and dependency.

  12 months post baseline

Secondary Outcomes (10)

• Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

  baseline

• Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

  3 months post baseline

• Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

  6 months post baseline

• Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

  9 months post baseline

• Alcohol use: Number days with a negative breathalyzer tests over 7 consecutive days

  12 months post baseline

Study Arms (2)

Intervention

EXPERIMENTAL

Four sessions with husband containing standard primary care based Motivational Interviewing techniques to reduce AUD in community populations. Wife joins 4th session on relapse prevention and support. This is followed by six Behavioral Couples Therapy sessions - see intervention description for content. All sessions are weekly, 1 hour in duration, delivered in person by a trained study nurse and include role plays and assignments to practice between sessions. Comic strips and graphics reinforce lessons and skills taught throughout the sessions.

Behavioral: Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT)

Enhanced usual care

NO INTERVENTION

For ethical reasons, to ensure participants in the control arm receive care for IPV and AUD, a) trained staff will conduct initial safety assessments for all patients; b) for IPV, wives will be referred to a legal cell at NIMHANS, a one-stop IPV center, and given information re. their options and local resources such as contact information for local organizations that can provide legal advice, counseling, and shelters; c) for AUD, participants will receive a brief educational session based on the World Health Organization's (WHO) manual for managing AUD in PHCs and referral to NIMHANS, a tertiary care mental health and addictions treatment center that has a dedicated referral system with the PHCs.

Interventions

Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• married couple with both spouses age ≥18;
• living within the catchment area of the PHC (primary health center);
• speaking Kannada or Hindi;
• the husband having Alcohol Use Disorder (AUD) measured by AUDIT-C (AUDIT-C ≥4).

You may not qualify if:

• 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);
• significant medical problems that will make the couple unable to participate in the intervention sessions;
• cognitive problems (adapted Short-Blessed Cognitive Test score ≤7);
• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• St. John's Research Institute: collaborator
• RTI International: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

St. John's Research Institute

Bangalore, Karnataka, India

RECRUITING

MeSH Terms

Conditions

Alcoholism

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Maria L Ekstrand, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Bibhav Acharya, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Krisnamachari Srinivasan, MD

  St John's Research Institute, Bengaluru India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L Ekstrand, PhD

CONTACT

(415) 476-6288; maria.ekstrand@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medical care providers at the recruitment site will be blinded to intervention arm. The intervention and assessment study staff do not overlap and all reasonable care is taken to keep assessment staff blinded to intervention allocation for the whole duration of the study. Investigators know intervention arm on a need to know basis but do not have contact with participants directly.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial of 400 married couples, a priori randomized (1:1) to intervention or enhanced usual care. Intervention duration of 3 months, quarterly assessments over a 12 month follow-up period.

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: June 7, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data will be submitted to the repository every 6 months. They will be publicly available 12 months after the end of the project, including any no cost extensions.
• Access Criteria: Data access requires sponsorship by an Institution on behalf of Recipient(s).

Locations

IN (1)