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Clinical Trials/NCT04460027
NCT04460027CompletedPhase 1

Woebot for Substance Use Disorders During COVID-19

Woebot Health1 site in 1 country180 target enrollmentStarted: June 22, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
180
Locations
1
Primary Endpoint
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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).

Exclusion Criteria

  • •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

Arms & Interventions

Wait List Control

No Intervention

W-SUDs

Experimental

Intervention: Woebot Substance Use Disorder (Other)

Outcomes

Primary Outcomes

Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks

Time Frame: 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

Secondary Outcomes

  • 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)

Investigators

Sponsor
Woebot Health
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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