Ireland
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Active, not recruiting Not applicable

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

NCT05893277 · tracked via the Priya Life Science India tracker
Phase
Not applicable
Started
2023-10-12
Last updated
2026-07-14

Condition(s) studied

Intimate Partner ViolenceAlcohol Use Disorder

Investigational drug(s) / intervention(s)

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

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Intimate Partner Violence: mean score on Indian Family Violence and Control Scale — baseline
    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.
  • Intimate Partner Violence: mean score on Indian Family Violence and Control Scale — 6 months post baseline
    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.
  • Intimate Partner Violence: mean score on Indian Family Violence and Control Scale — 12 months post baseline
    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.
  • Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score — baseline
    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.
  • Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score — 3 months post baseline
    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.
  • Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score — 6 months post baseline
    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.
  • Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score — 9 months post baseline
    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.
  • Alcohol use and dependency: AUDIT (Alcohol Use Disorders Identification Test) score — 12 months post baseline
    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.

Trial sites (1)

FacilityCityRegionStatus
St. John's Research Institute Bangalore Karnataka

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05893277 on ClinicalTrials.gov ↗ ← All trials in India