Coordinated Care for Alcohol Problems (CCAP): a Randomised Controlled Trial From Goa, India
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,022
- 主要终点
- Percentage days abstinent (PDA) [Parent trial]
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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).
研究组 & 干预措施
CCAP
Hazardous drinking: M-BIT is an eight-week digital intervention delivered over WhatsApp.
Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. CAP+ will include treatment engagement strategies integrated into CAP.
Dependent drinking: CONTAD is a manualised treatment comprising of 5-7 days of supervised home detoxification followed by relapse prevention counselling for dependent drinking.
Participants with harmful and dependent drinking level will be offered referral to the public District Hospitals or the state Psychiatric Hospital for assessment of eligibility for anti-craving medicines if available and to be prescribed and dispensed as per their Standard Operating Procedures.
干预措施: CCAP (Behavioral)
Enhanced usual care
Hazardous drinking: Brief intervention leaflet which is an information sheet/brochure with information on alcohol consumption, associated risks, and tips to manage and reduce drinking.
Harmful drinking: CAP is a manualised brief psychological treatment for harmful drinking. It 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 has proven to be effective and cost-effective in reducing drinking in men with harmful level of drinking in a prior study. CAP can be delivered in any of the local vernacular (Hindi, Marathi, Konkani) or English.
Dependent drinking: Supported in-patient detoxification which is hospital-based detoxification delivered in secondary or tertiary care.
干预措施: Enhanced usual care (Behavioral)
结局指标
主要结局
Percentage days abstinent (PDA) [Parent trial]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 3 months post randomisation
Units of alcohol consumed in the past week measured using the TLFB
次要结局
- Percentage days abstinent (PDA) [Parent trial](6 months post randomisation)
- Consequences of alcohol use [Parent trial](3 months post randomisation)
- Consequences of alcohol use [Parent trial](6 months post randomisation)
- Pattern of drinking [Parent trial](3 months post randomisation)
- Pattern of drinking [Parent trial](6 months post randomisation)
- Intensity of drinking [Parent trial](3 months post randomisation)
- Intensity of drinking [Parent trial](6 months post randomisation)
- Remission [Parent trial](3 months post randomisation)
- Remission [Parent trial](6 months post randomisation)
- Out-of-pocket costs 1 [Parent trial](3 months post randomisation)
- Out-of-pocket costs 1 [Parent trial](6 months post randomisation)
- Out-of-pocket costs 2 [Parent trial](3 months post randomisation)
- Out-of-pocket costs 2 [Parent trial](6 months post randomisation)
- Disability [Parent trial](3 months post randomisation)
- Disability [Parent trial](6 months post randomisation)
- Pattern of drinking [Sub-group A Hazardous drinking](6 months post randomisation)
- Intensity of drinking [Sub-group A Hazardous drinking](3 months post randomisation)
- Intensity of drinking [Sub-group A Hazardous drinking](6 months post randomisation)
- Remission [Sub-group A Hazardous drinking](3 months post randomisation)
- Remission [Sub-group A Hazardous drinking](6 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group A Hazardous drinking](3 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group A Hazardous drinking](6 months post randomisation)
- Pattern of drinking [Sub-group A Hazardous drinking](3 months post randomisation)
- Treatment entry [Sub-group B Harmful drinking](3 months post randomisation)
- Treatment entry [Sub-group B Harmful drinking](6 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group B Harmful drinking](3 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group B Harmful drinking](6 months post randomisation)
- Pattern of drinking [Sub-group B Harmful drinking](3 months post randomisation)
- Pattern of drinking [Sub-group B Harmful drinking](6 months post randomisation)
- Intensity of drinking [Sub-group B Harmful drinking](3 months post randomisation)
- Intensity of drinking [Sub-group B Harmful drinking](6 months post randomisation)
- Remission [Sub-group B Harmful drinking](3 months post randomisation)
- Remission [Sub-group B Harmful drinking](6 months post randomisation)
- Consequences of alcohol use [Sub-group B Harmful drinking](3 months post randomisation)
- Consequences of alcohol use [Sub-group B Harmful drinking](6 months post randomisation)
- Intensity of drinking [Sub-group C Dependent drinking](6 months post randomisation)
- Consequences of alcohol use [Sub-group C Dependent drinking](3 months post randomisation)
- Consequences of alcohol use [Sub-group C Dependent drinking](6 months post randomisation)
- Remission [Sub-group C Dependent drinking](3 months post randomisation)
- Remission [Sub-group C Dependent drinking](6 months post randomisation)
- Out-of-pocket costs 1 [Parent trial](12 months post randomisation)
- Out-of-pocket costs 2 [Parent trial](12 months post randomisation)
- Percentage days abstinent (PDA) [Parent trial](12 months post randomisation)
- Remission [Parent trial](12 months post randomisation)
- System-level costs [Parent trial](Monthly, during the period of implementation)
- Consequences of alcohol use [Parent trial](12 months post randomisation)
- Food security [Parent trial](12 months post randomisation)
- Pattern of drinking [Parent trial](12 months post randomisation)
- Intensity of drinking [Parent trial](12 months post randomisation)
- Disability [Parent trial](12 months post randomisation)
- Pattern of drinking [Sub-group A Hazardous drinking](12 months post randomisation)
- Intensity of drinking [Sub-group A Hazardous drinking](12 months post randomisation)
- Remission [Sub-group A Hazardous drinking](12 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group A Hazardous drinking](12 months post randomisation)
- Treatment entry [Sub-group B Harmful drinking](12 months post randomisation)
- Percentage days abstinent (PDA) [Sub-group B Harmful drinking](12 months post randomisation)
- Pattern of drinking [Sub-group B Harmful drinking](12 months post randomisation)
- Intensity of drinking [Sub-group B Harmful drinking](12 months post randomisation)
- Remission [Sub-group B Harmful drinking](12 months post randomisation)
- Consequences of alcohol use [Sub-group B Harmful drinking](12 months post randomisation)
- Food security [Sub-group B Harmful drinking](12 months post randomisation)
- Intensity of drinking [Sub-group C Dependent drinking](12 months post randomisation)
- Consequences of alcohol use [Sub-group C Dependent drinking](12 months post randomisation)
- Food security [Sub-group C Dependent drinking](12 months post randomisation)
- Remission [Sub-group C Dependent drinking](12 months post randomisation)
- Treatment entry [Sub-group C Dependent drinking](Through the period of intervention delivery, an average of 3 months)
- Treatment completion [Sub-group C Dependent drinking](Through the period of intervention delivery, an average of 3 months)