Remote Treatment With Incentives for Sobriety (TRIS): A Randomized Controlled Trial of a Contingency Management App for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Days of Alcohol Abstinence
研究概览
简要总结
Alcohol Use Disorder (AUD) is a major public health concern associated with substantial morbidity, mortality, and impaired social and occupational functioning. Contingency Management (CM) is an evidence-based behavioral intervention that provides incentives contingent on abstinence and has demonstrated effectiveness in the treatment of substance use disorders. This study will evaluate the efficacy of Tratamento Remoto com Incentivos à Sobriedade (TRIS), a Brazilian mobile health application that integrates a smartphone app with a Bluetooth-enabled breathalyzer (BACtrack) to deliver remote CM for AUD. Participants will be randomized to receive either standard outpatient treatment plus TRIS-based CM or standard outpatient treatment with remote alcohol monitoring only. The primary objective is to determine whether TRIS-based CM increases biochemically verified alcohol abstinence compared with standard outpatient treatment alone.
详细描述
A total of 130 adults with Alcohol Use Disorder (AUD) from two public outpatient clinics in São Paulo, Brazil, will be randomized (1:1) to the experimental or control group. The experimental group will receive standard outpatient treatment plus 12 weeks of remote Contingency Management (CM) delivered through the TRIS mobile application. Participants will submit three daily breath alcohol concentration (BrAC) samples at 1:00 p.m., 5:00 p.m., and 9:00 p.m. using a BACtrack Bluetooth breathalyzer connected to the app. Financial incentives will be provided when all three daily samples are submitted on time and are alcohol-negative (BrAC = 0.00). Incentives begin at R$5.00 per day and increase by R$2.00 for each consecutive day of verified abstinence, up to a maximum of R$15.00 per day. Missed or alcohol-positive samples reset the incentive value to R$5.00 on the next eligible day. Incentives will be redeemed via PIX transfer. The control group will receive standard outpatient treatment and will also use the TRIS application and BACtrack breathalyzer to submit three daily BrAC samples but will not receive contingency management incentives. The primary outcome is the number of biochemically verified days of alcohol abstinence during the 12-week intervention. Secondary outcomes include days without heavy alcohol use, treatment adherence, usability and acceptability of the TRIS application, alcohol withdrawal severity, obsessive-compulsive drinking symptoms, alcohol craving, alcohol use severity, quality of life, psychiatric symptoms, disability, and healthcare service utilization. Assessments will be conducted at baseline, weekly during the 12-week intervention, and at follow-up visits scheduled at Weeks 16, 20, and 24.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to read and speak Portuguese.
- •Provide signed informed consent.
- •Age 18 to 70 years.
- •Alcohol consumption within the past month.
- •Current diagnosis of Alcohol Use Disorder (AUD).
- •Seeking treatment for AUD at AME Vila Maria or Instituto Perdizes.
- •Breath alcohol concentration (BrAC) of 0.00 at the time of consent.
- •Own and be able to operate a smartphone with an active mobile service plan.
- •Smartphone compatible with the Bluetooth frequency required for the BACtrack breathalyzer.
排除标准
- •Crack cocaine use within the past 90 days.
- •Any seizure episode within the past 12 months.
- •Diagnosis of a psychotic disorder (DSM-5).
- •Suicide attempt within the past two years.
- •Any medical or psychiatric condition that may compromise safe participation, as determined by the study medical director.
结局指标
主要结局
Days of Alcohol Abstinence
时间窗: Up to 12 weeks
Number of days with verified abstinence based on three daily BrAC samples submitted via the BACtrack remote breathalyzer over the 12-week intervention period.
次要结局
- Days without Heavy Alcohol Consumption(Up to 12 weeks)
- App Usability(Week 12 (end of intervention))
- Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)(Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.)
- Obsessive-Compulsive Drinking Scale (OCDS)(Baseline (Week 0), weekly during Weeks 1-12, and follow-up at Weeks 16, 20, and 24.)
- Treatment Adherence(Up to 12 weeks)