Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Number of Substance Use Occasions
研究概览
简要总结
Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic 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
- 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
- •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.
- •Ever used Woebot
研究组 & 干预措施
W-SUDs
Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.
干预措施: W-SUDs (Device)
Digitally-delivered Psychoeducation
Psychoeducation digitally delivers weekly fact sheets that include information on:
- Alcohol-specific topics;
- Drug-specific topics;
- General addiction topics;
- Statistics relating to alcohol and substance use.
干预措施: Digitally-delivered Psychoeducation (Other)
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 1-Month Follow-up at 12 weeks
Change in number of substance use occasions in the past 30 days
次要结局
- Working Alliance Inventory (WAI-SR)(Difference between Mid-treatment at 4 weeks and Post-treatment at 8 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 1-Month Follow-up at 12 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 1-Month Follow-up at 12 weeks)
- Stanford Presenteeism Scale (SPS-6)(Change from Baseline to Post-treatment at 8 weeks)
- Thoughts About Abstinence (TAA)(Change from Baseline to Post-treatment at 8 weeks)
- CAIR Pandemic Impact Questionnaire (C-PIQ)(Change from Baseline to Post-treatment at 8 weeks)
- Past Month Average Days Per Week of Drinking Alcohol(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month 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 1-Month 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 1-Month 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 1-Month Follow-up at 12 weeks)
- Past Month Average Standard Drinks in a Day(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month 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 1-Month 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 1-Month Follow-up at 12 weeks)
- Client Satisfaction Questionnaire (CSQ)(Post-treatment (8 weeks from baseline))
- Usage Rating Profile - Intervention (URPI)-Acceptability(Post-treatment (8 weeks from baseline))
- Usage Rating Profile Intervention - Intervention (URPI)-Feasibility(Post-treatment (8 weeks from baseline))
- Number of Participants Indicating Substance Use(Baseline)
- Number of Participants Providing PEth Sample Phosphatidylethanol (PEth)(Baseline and Post-treatment at 8 weeks)
- Engagement With Control Condition(Baseline to Post-treatment at 8 weeks)