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Harmony
A Combined Motivational Interviewing and Behavioral Couples Therapy Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India
Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
800
1 country
1
Study Start
October 12, 2023
Actual (reported)Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 12, 2023
Actual (reported)June 7, 2023
Actual (reported)October 12, 2023
Actual (reported)May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St. John's Research Institute
Bangalore, Karnataka, India
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
First Submitted
May 12, 2023
First Posted
June 7, 2023
Study Start
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
Contact the study team to confirm eligibility.
October 12, 2023
Actual (reported)Primary Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 14, 2026
Record last verified: 2026-07
De-identified data will be deposited in the NIAAA data archive in accordance with informed consent of research participants and with the approval of the Institutional Review Board, for research purposes by approved users.
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Source: ClinicalTrials.gov.
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