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临床试验/NCT04460027
NCT04460027已完成1 期

Woebot for Substance Use Disorders During COVID-19

Woebot Health1 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
干预措施

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
1
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

研究组 & 干预措施

Wait List Control

No Intervention

W-SUDs

Experimental

干预措施: Woebot Substance Use Disorder (Other)

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

  • 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))
  • 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 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 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)
  • 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

发起方
Woebot Health
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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