Coordinated Care for Alcohol Problems

Official title

Coordinated Care for Alcohol Problems (CCAP): a Randomised Controlled Trial From Goa, India

Overview

Parallel group individually randomised controlled trial (RCT) with stratified (by severity of drinking problem) randomisation into intervention and control arms. Aim is to test the effectiveness and cost-effectiveness of Coordinated Care for Alcohol Problems (CCAP) for the whole spectrum of drinking problems in primary care in Goa, India. Primary outcome is the drinking outcome of percentage days abstinent (PDA) at three months post randomisation. Secondary outcomes include drinking outcomes (PDA at six- and 12- months post-randomisation; percentage days heavy drinking (PDHD), intensity of drinking and remission) and drinking related outcomes (e.g., injuries, violence) at three-, six- and 12- months post- randomisation. Participants will include consenting adult (\>18 years) men with drinking problems attending Primary Healthcare Centres (PHCs) and Community Healthcare Centres (CHCs) in Goa and have drinking problems defined as scoring \>8 on the Alcohol Use Disorder Identification Test (AUDIT). CCAP is a multi-component evidence-informed complex intervention package for coordinating treatment for all levels of problem drinking (hazardous, harmful, dependent). For hazardous drinking, it includes Mobile based Brief Intervention Treatment (M-BIT), which is a mobile-messaging brief intervention delivered via WhatsApp over eight weeks using multimedia content including contextually relevant messages, images and videos. For harmful drinking, it includes Counselling for Alcohol Problems Plus (CAP+) which is Counselling for Alcohol Problems (CAP), an evidence-based brief psychological treatment, integrated with strategies to enhance treatment engagement (entry into and completion). For dependent drinking, it includes Community Orientated Treatment for Alcohol Dependence (CONTAD) which is supervised home-detoxification over a week followed by a psychological treatment to prevent relapse, both integrated with treatment engagement strategies. CAP+ and CONTAD will be delivered in the community by non-specialist health workers (NSHW).

Interventions

• Behavioral CCAP
  Hazardous drinking: The content of the intervention includes seven themes: health education, alcohol reduction, drinking and risk management, drinking alternatives, situational content, urge management, and relapse prevention. Participants will receive texts and video-based messages building their awareness about drinking and associated harms. Harmful drinking: CAP has three phases which are delivered in one to four sessions over six to eight weeks by NSHWs. Each session lasts between 30 to 45
• Behavioral Enhanced usual care
  Hazardous drinking: An information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking. Harmful drinking: CAP psychological brief treatment delivered by trained NSHWs (described above in detail). Dependent drinking: Hospital-based detoxification delivered in secondary or tertiary care.

Primary outcome measures

• Percentage days abstinent (PDA) [Parent trial] [Time frame: 3 months post randomisation]
• Pattern of drinking [Sub-group A Hazardous drinking] [Time frame: 3 months post randomisation]
• Treatment completion [Sub-group B Harmful Drinking] [Time frame: Through the period of intervention delivery, an average of 3 months]
• Intensity of drinking [Sub-group C Dependent drinking] [Time frame: 3 months post randomisation]

Secondary outcome measures (12)

• Percentage days abstinent (PDA) [Parent trial] [Time frame: 6 months post randomisation]
• Percentage days abstinent (PDA) [Parent trial] [Time frame: 12 months post randomisation]
• Consequences of alcohol use [Parent trial] [Time frame: 3 months post randomisation]
• Consequences of alcohol use [Parent trial] [Time frame: 6 months post randomisation]
• Consequences of alcohol use [Parent trial] [Time frame: 12 months post randomisation]
• Food security [Parent trial] [Time frame: 12 months post randomisation]
• Pattern of drinking [Parent trial] [Time frame: 3 months post randomisation]
• Pattern of drinking [Parent trial] [Time frame: 6 months post randomisation]
• Pattern of drinking [Parent trial] [Time frame: 12 months post randomisation]
• Intensity of drinking [Parent trial] [Time frame: 3 months post randomisation]
• Intensity of drinking [Parent trial] [Time frame: 6 months post randomisation]
• Intensity of drinking [Parent trial] [Time frame: 12 months post randomisation]

Eligibility criteria

Inclusion criteria

• Scoring positive for problem drinking (≥ 8 on the AUDIT)
• Have been residing in Goa for more than 12 continuous preceding months as an indicator of stability of residence which would be required both for treatment delivery and completion of outcome evaluation.
• Language:

• For hazardous drinking (AUDIT score of 8-15), patients must be able to understand at least one of the local vernacular languages (Hindi or Konkani) or English. Patients must be able to read at least one of the local vernacular languages (Hindi or Marathi) or English.
• For harmful and dependent drinking (AUDIT score of >15), patients must be able to understand and speak any of the local vernacular languages (Konkani, Marathi, Hindi) or English.
• For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp.
• For dependent drinking (AUDIT score of >19), patients must consent for home visits and must also be eligible for home detoxification as per structured detoxification protocol.

Exclusion criteria

• For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention.
• For harmful and dependent drinking, patients with significant speech, hearing, or language impairment (as evident during screening) will be excluded as the intervention is primarily a 'talking treatment'.
• For patients who present to the PHC/CHC needing urgent medical attention (emergency treatment or in-patient admission), screening will be deferred until their condition is stable.
• Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol.
• Those who are alcohol dependent but are currently not drinking. As AUDIT covers a period of 12 months, it will also detect those who meet the criteria for alcohol dependence over the past 12 months but are currently abstinent (hence not eligible for detoxification).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07260149 · AN_2025_119

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗