NCT04974645已完成不适用
Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use
Woebot Health4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年11月3日最近更新:
适应症
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
- 4
- 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
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)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
不适用
MindfulGarden in Treatment of Hyperactive Delirium in a Hospital SettingHyperactive DeliriumNCT03621228Simon Fraser University24
已完成
早期 1 期
Comparing Enoxaparin to Fondaparinux to Prevent Venous Thromboembolism (VTE) in Bariatric Surgical PatientsDeep Venous ThrombosisPulmonary EmbolismNCT00894283Johns Hopkins University198
Unknown
不适用
Digital Lifestyle Intervention For Diabetes/Pre-DiabetesType 2 DiabetesObesityPreDiabetesNCT05247437The University of Hong Kong120
已完成
不适用
Feasibility of an Interprofessional Rehabilitation Program for Chronic Low Back Patients in the Ethiopian Health SettingChronic Low-back PainNCT05866146Sintayehu Wami40
已完成
不适用
Testing the Feasibility and Preliminary Effect of Summer CampChildhood Obesity PreventionNCT04085965The Miriam Hospital94