RCT of Woebot for Substance Use Disorders Phase 1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
研究概览
简要总结
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •All genders
- •18-65 years
- •Must have access to a smartphone and able to download the W-SUDs app
- •Committed to engage with app and complete assessments
- •Be willing to provide email address (to distribute incentives)
- •Be literate in English (as W-SUDs conversational and video materials will be in English)
- •Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use
排除标准
- •Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- •Suicide attempt or within the past year
- •Drug or alcohol overdose within the past year
结局指标
主要结局
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
时间窗: Change from Baseline to Post-treatment at 8 weeks
The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
时间窗: Change from Baseline to Post-treatment at 8 weeks
The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
时间窗: Change from Baseline and Post-treatment at 8 weeks
The number of days a substance was used the past 30 days
次要结局
- The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks(Post-treatment at 8 weeks)
- Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks(Post-treatment at 8 weeks)
- Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks(Post-treatment at 8 weeks)
- Change Pain Rating From Baseline to Post-Treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks(Change from Baseline to Post-Treatment at 8 weeks)
- Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks(Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks)
- Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks(Change from Baseline to Post-Treatment at 8 weeks)