NCT04460027已完成1 期
Woebot for Substance Use Disorders During COVID-19
Woebot Health2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2020年6月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
研究概览
简要总结
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.
This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All genders aged 18-65 years
- •Access to a smartphone
- •Available and committed to engage with app and complete assessments
- •Be willing to provide email address (as this is how assessment incentives will be distributed),
- •Literate in English (as W-SUDs conversational and video 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)
- •History of severe drug/alcohol use
- •History of opioid misuse without medication-assisted treatment
- •Suicide attempt within the past year
- •Opioid overdose within the past year
结局指标
主要结局
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
时间窗: Change from Baseline to Post-treatment at 8 weeks
Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
次要结局
- Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
- Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 Weeks)
- Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks(Post-treatment (8 weeks from Baseline))
- Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks(Post-treatment (8 weeks from Baseline))
- Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks(Post-treatment (8 weeks from Baseline))
- Change in 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 in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks(Change from Baseline to Post-treatment at 8 weeks)
研究者
研究点 (2)
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