Coordinated Care for Alcohol Problems

Condition(s) studied

Investigational drug(s) / intervention(s)

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 minutes. The content is delivered through motivational interviewing with additional behavioural and cognitive components. CAP+ will include treatment engagement strategies integrated into CAP. Dependent drinking: Home detoxification will be supervised by a doctor and monitored by the NSHW and a designated carer (e.g. spouse) for the patient at their home-setting. The counselling sessions are delivered by NSHWs, over 4-8 weeks and lasting 30-60 minutes each.

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.

Study summary

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).

Eligibility

Primary outcome measure(s)

• Percentage days abstinent (PDA) [Parent trial] — 3 months post randomisation
  Proportion of days abstinent in the past two weeks measured using the Timeline Follow Back (TLFB)
• Pattern of drinking [Sub-group A Hazardous drinking] — 3 months post randomisation
  Number of heavy drinking days in the past two weeks measured using the TLFB
• Treatment completion [Sub-group B Harmful Drinking] — Through the period of intervention delivery, an average of 3 months
  Proportion of consented participants who go on to complete treatment defined as planned discharge which would be one of the following 1. Received all sessions as per protocol 2. Discharge by mutual agreement between NSHW and participant on achievement of treatment goals 3. Referral out of the study
• Intensity of drinking [Sub-group C Dependent drinking] — 3 months post randomisation
  Units of alcohol consumed in the past week measured using the TLFB

Trial sites (1)

Other trials for the same condition