Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 2
- 主要终点
- Change in Number of Substance Use Occasions
研究概览
简要总结
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.
详细描述
Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation control condition. Primary outcomes will be measures of the quantity and frequency of substance use including number of substance use occasions, heavy drinking days (if applicable) and percent reduction in substance use occasions. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control,
- improves symptoms of depression and anxiety;
- improves work productivity (i.e. reduce presenteeism/absenteeism);
- reduces cravings;
- improves situational confidence to resist substance use.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a smartphone
- •Endorse a substance use concern
- •Be between 18 and 65 years of age
- •Be available and committed to engage with the Woebot app
- •Be literate in English. (This is required for inclusion because all materials will be in English).
排除标准
- •Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- •Suicide attempt within the past year (12 months)
- •Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
- •Opioid overdose within the past year (12 months)
- •Opioid misuse without medication-assisted treatment
- •Not residing in the U.S.
- •Previous Woebot use
结局指标
主要结局
Change in Number of Substance Use Occasions
时间窗: Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks
Change in number of substance use occasions in the past 30 days
次要结局
- Drug Abuse Screening Test (DAST-10)(Change from Baseline to Post-treatment at 8 weeks)
- Working Alliance Inventory (WAI-SR)(Post-treatment at 8 weeks)
- Stanford Presenteeism Scale (SPS-6)(Change from Baseline to Post-treatment at 8 weeks)
- Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items(Change from Baseline to Post-treatment at 8 weeks)
- Thoughts About Abstinence (TAA): Goal Item(Baseline and Post-treatment at 8 weeks)
- Usage Rating Profile - Intervention (URPI)-Acceptability(Post-treatment at 8 weeks)
- Usage Rating Profile - Intervention (URPI)-Feasibility(Post-treatment at 8 weeks)
- Client Satisfaction Questionnaire (CSQ-8)(Post-treatment at 8 weeks)
- Short Inventory of Problems- Alcohol and Drugs (SIP-AD)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Patient Health Questionnaire (PHQ-8)(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Generalized Anxiety Disorder (GAD-7)(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Brief Situational Confidence Questionnaire (BSCQ)(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Craving Ratings(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Past Month Number of Binge Days(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)
- Past Month Average Standard Drinks in a Week(Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks)