[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507891":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":39,"responsibleParty":58,"collaborators":60,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":18,"enrollmentInfo":77,"targetDuration":18,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Motivational Interviewing (MI) and Behavioral Couples Therapy (BCT)",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"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.",[9],[26,29,31],{"name":27,"affiliation":5,"role":28},"Maria L Ekstrand, PhD","PRINCIPAL_INVESTIGATOR",{"name":30,"affiliation":5,"role":28},"Bibhav Acharya, MD",{"name":32,"affiliation":33,"role":28},"Krisnamachari Srinivasan, MD","St John's Research Institute, Bengaluru India",[35],{"name":27,"role":36,"phone":37,"phoneExt":18,"email":38},"CONTACT","(415) 476-6288","maria.ekstrand@ucsf.edu",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":18,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"St. John's Research Institute","RECRUITING","Bangalore","Karnataka","India","IN",{"type":48,"coordinates":49},"Point",[50,51],77.59369,12.97194,{"lat":51,"lon":50},[54,56],{"name":55,"role":36,"phone":18,"phoneExt":18,"email":18},"Matilda Pereira",{"name":57,"role":28,"phone":18,"phoneExt":18,"email":18},"Krishnamachari Srinivasan, MD",{"type":59,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[61,62,64],{"name":41,"class":6},{"name":63,"class":6},"RTI International",{"name":65,"class":66},"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","NIH","100507891","harmony-a-combined-mi-and-bct-intervention-to-reduce-intimate-partner-violence-and-alcohol-use-in-south-india-100507891",false,"NCT05893277","Harmony: A Combined MI and BCT Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India","A Combined Motivational Interviewing and Behavioral Couples Therapy Intervention to Reduce Intimate Partner Violence and Alcohol Use in South India","Harmony","Inclusion Criteria:\n\n1. married couple with both spouses age ≥18;\n2. living within the catchment area of the PHC (primary health center);\n3. speaking Kannada or Hindi;\n4. wife reporting any physical or sexual intimate partner violence (IPV) in the past 12 months (note exclusion for severe IPV below);\n5. the husband having Alcohol Use Disorder (AUD) measured by AUDIT-C (AUDIT-C ≥4).\n\nExclusion Criteria:\n\n1. 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);\n2. significant medical problems that will make the couple unable to participate in the intervention sessions;\n3. cognitive problems (adapted Short-Blessed Cognitive Test score ≤7);\n4. 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).","ALL","18 Years",{"count":78,"type":79},800,"ESTIMATED","INTERVENTIONAL",[82],"NA","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.\n\nThe main question\\[s\\] it aims to answer are:\n\n* 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?\n* 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.\n\nThese 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.\n\nAll 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.",[85,86],"Intimate Partner Violence","Alcohol Use Disorder",[88,89,90,45,91],"Randomized Controlled Trial","Motivational Interviewing","Behavioral Couples Therapy","Nurse-delivered intervention","2025-07-02",{"date":94,"type":95},"2025-07-04","ACTUAL",{"date":97,"type":95},"2023-10-12",{"date":99,"type":79},"2027-05-31",{"name":5,"class":6},1]