Cost Effectiveness of Combined Contingency Management and Cognitive Behavioral Therapy for Alcohol Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Average Number of Heavy Drinking Days
研究概览
简要总结
Alcohol contributes to 88,000 deaths and costs an estimated $223 billion annually in the United States. Alcohol use disorder (AUD) is highly prevalent in veterans. The positive public health impact of reducing heavy drinking among veterans with AUD would prevent significant medical morbidity and mortality. Contingency management (CM) is an intensive behavioral therapy that provides incentives to individuals for reducing substance use. Monitoring alcohol abstinence usually requires daily monitoring. Because of this difficulty, CM approaches for treatment of AUD are not currently available to people with AUD. Our group has developed a mobile smart-phone application that allows patients to video themselves using an alcohol breath monitor and transmit the encrypted data to a secure server. This innovation has made the use of CM for outpatient AUD treatment feasible. The aim of the current study is to evaluate the effectiveness and cost effectiveness of CM as an add-on to cognitive behavioral therapy for AUD. The trial will also explore the potential usefulness of a long-term abstinence incentive ontreatment utilization and alcohol outcomes. Proposed is a trial in which 140 veterans with AUD will be randomized to receive either CM as an add-on to evidence-based CBT or CBT alone. Veterans will also be randomized to one of two long-term incentive conditions (i.e., receipt of a monetary incentive for abstinence/low-risk drinking at 6- months vs. no incentive). This project aims to advance AUD treatment by 1) testing the effectiveness of a mobile health approach that makes CM for AUD feasible, and 2) providing highly needed cost-effectiveness data on the use of behavioral incentives as an adjunct to CBT for the treatment of AUD. These aims are designed to address two significant barriers to the implementation of CM for AUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are an enrolled veteran at the DVAHCS for primary care,
- •have current AUD (meeting past month DSM-5 criteria), and
- •are willing to make a quit attempt and/or reduce alcohol use to low risk levels.
排除标准
- •have fewer than 3 days of abstinence,
- •have a history of clinically significant alcohol withdrawal, as indicated by a score of 10 or more on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA), or
- •are currently receiving professional behavioral treatment for AUD.
研究组 & 干预措施
CBT + mCM + incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT + mCM + incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up.
干预措施: Mobile Contingency Management (mCM) (Behavioral)
CBT + mCM + incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment, mobile contingency management for alcohol abstinence, and a monetary incentive for 30-day abstinence at the 6-month follow-up.
干预措施: Long-term incentive (Behavioral)
CBT + mCM + no incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT + mCM + no incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and mobile contingency management for alcohol abstinence. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up.
干预措施: Mobile Contingency Management (mCM) (Behavioral)
CBT alone + incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
CBT alone + incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment and a monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.
干预措施: Long-term incentive (Behavioral)
CBT alone + no incentive
Participants in this arm will receive 12 sessions of cognitive behavioral treatment. They will not receive monetary incentive for 30-day abstinence at the 6-month follow-up. They will not receive contingency management for alcohol abstinence during the treatment period.
干预措施: Cognitive Behavioral Therapy (CBT) (Behavioral)
结局指标
主要结局
Average Number of Heavy Drinking Days
时间窗: 6-month post quit visit
At the 6-month follow-up visit, participants will self-report the number of heavy drinking (\> 5 drinks in day for men, \> 4 drinks in a day for women) days they have had in the past thirty days.
次要结局
- Health Care Related Quality of Life as Measured by the EuroQol (EQ-5D)(12-month post quit visit)
- Incremental Cost-Effectiveness Ratio(12-month post quit visit)
- Average Number of Drinks Per Drinking Day(12-month post quit visit)
- CBT Treatment Engagement as Measured by the Number of Cognitive Behavioral Therapy Treatment Sessions Completed(Post-treatment, approximately 14 weeks)
- Average Number of Heavy Drinking Days(12-month post quit visit)
- Average Number of Binge Drinking Days(12-month post quit visit)
- Average Number of Drinking Days(12-month post quit visit)
- Number of Participants With Self-reported Abstinence(12-month post quit visit)
- Number of Participants With Bioverification of Low-risk Drinking(12-month post quit visit)
- Treatment Utilization as Measured by Number of Treatment Visits(12-month post quit visit)
- Average Number of Binge Drinking Days(6-month post quit visit)
- Average Number of Drinking Days(6-month post quit visit)
- Average Number of Drinks Per Drinking Day(6-month post quit visit)
- Number of Participants With Self-reported Abstinence(6-month post quit visit)
- Number of Participants With Bioverification of Low-risk Drinking(6-month post quit visit)
- Treatment Utilization as Measured by Number of Treatment Visits(6-month post quit visit)