Alcohol Use Disorder
Conditions
Keywords
Alcohol use disorder, Coordinated care, Complex intervention, Digital intervention, Psychosocial intervention, Non-specialist health workers, Task-sharing, Randomised controlled trial, India
Brief 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).
Interventions
BEHAVIORALCCAP
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.
BEHAVIORALEnhanced 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.
Sponsors
Sangath
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Scoring positive for problem drinking (≥ 8 on the AUDIT) 2. 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. 3. Language: 1. 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. 2. 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. 4. For hazardous drinking, patients must also have access to a personal smartphone with WhatsApp. 5. 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
1. For hazardous drinking, patients with significant visual or hearing impairment will be ineligible due to the audio-visual nature of the intervention. 2. 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'. 3. 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. 4. Those who are alcohol dependent and do not meet the eligibility criteria for home detoxification as per protocol. 5. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage days abstinent (PDA) [Parent trial] | 6 months post randomisation | Proportion of days abstinent in the past two weeks measured using the Timeline Follow |
| Consequences of alcohol use [Parent trial] | 3 months post randomisation | Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP) |
| Food security [Parent trial] | 12 months post randomisation | Improvement of food security as measured using Food Insecurity Experience Scale |
| Pattern of drinking [Parent trial] | 3 months post randomisation | Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB |
| Intensity of drinking [Parent trial] | 3 months post randomisation | Grams ethanol consumed per drinking day in the past two weeks measured using the TLFB |
| Remission [Parent trial] | 3 months post randomisation | Alcohol Use Disorder Identification Test (AUDIT) score \<8 |
| System-level costs [Parent trial] | Monthly, during the period of implementation | Economic costs in WHO six building blocks for delivering the interventions measured using inventory form for collecting system-level economic costs of delivering interventions (finance records and individuals involved in delivery of interventions) |
| Out-of-pocket costs 1 [Parent trial] | 3 months post randomisation | Out-of-pocket costs for receiving general medical care and the related non-medical costs (e.g.: time loss, travel, etc) measured using Client Service Receipt Inventory form for collecting costs to patients who receive CCAP interventions |
| Out-of-pocket costs 2 [Parent trial] | 3 months post randomisation | Out-of-pocket costs for receiving CCAP interventions (e.g.: time loss, travel, etc) using survey form for receiving the CCAP interventions to patients who receive CCAP interventions |
| Disability [Parent trial] | 3 months post randomisation | Standardised disability scores used to estimate Quality-Adjusted Life Years (QALYs) using the WHO Disability Assessment Scale (WHODAS) |
| Pattern of drinking [Sub-group A Hazardous drinking] | 6 months post randomisation | Number of heavy drinking days in the past two weeks measured using the TLFB |
| Intensity of drinking [Sub-group A Hazardous drinking] | 3 months post randomisation | Grams ethanol consumed per drinking day in past two weeks measured using the TLFB |
| Remission [Sub-group A Hazardous drinking] | 3 months post randomisation | Alcohol Use Disorder Identification Test (AUDIT) score \<8 |
| Percentage days abstinent (PDA) [Sub-group A Hazardous drinking] | 3 months post randomisation | Proportion of days abstinent in the past two weeks measured using the TLFB |
| Treatment entry [Sub-group B Harmful drinking] | 3 months post randomisation | Proportion of consented participants who receive at least one session of counselling |
| Percentage days abstinent (PDA) [Sub-group B Harmful drinking] | 3 months post randomisation | Proportion of days abstinent in the past two weeks measured using the TLFB |
| Pattern of drinking [Sub-group B Harmful drinking] | 3 months post randomisation | Percentage days heavy drinking (PDHD) in the past two weeks measured using the TLFB |
| Intensity of drinking [Sub-group B Harmful drinking] | 3 months post randomisation | Grams ethanol consumed per drinking day in past two weeks measured using the TLFB |
| Remission [Sub-group B Harmful drinking] | 3 months post randomisation | Alcohol Use Disorder Identification Test (AUDIT) score \<8 |
| Consequences of alcohol use [Sub-group B Harmful drinking] | 3 months post randomisation | Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP) |
| Food security [Sub-group B Harmful drinking] | 12 months post randomisation | Improvement of food security as measured using Food Insecurity Experience Scale |
| Intensity of drinking [Sub-group C Dependent drinking] | 6 months post randomisation | Units of alcohol consumed in the past week measured using TLFB |
| Consequences of alcohol use [Sub-group C Dependent drinking] | 3 months post randomisation | Physical, social, intrapersonal and interpersonal consequences of alcohol use measured using the Short Inventory of Problems (SIP) |
| Food security [Sub-group C Dependent drinking] | 12 months post randomisation | Improvement of food security as measured using Food Insecurity Experience Scale |
| Remission [Sub-group C Dependent drinking] | 3 months post randomisation | Alcohol Use Disorder Identification Test (AUDIT) score \<8 |
| Treatment entry [Sub-group C Dependent drinking] | Through the period of intervention delivery, an average of 3 months | Proportion of consented participants who receive at least one session of counselling |
| Treatment completion [Sub-group C Dependent 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 program |
Contacts
CONTACTAbhijit Nadkarni
CONTACTUrvita Bhatia
Outcome results
None listed