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Woebot for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096001
Recruitment Status : Completed
First Posted : September 19, 2019
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Woebot Labs, Inc.

Study Description
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Brief Summary:
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Device: Woebot-SUDs (W-SUDs) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT of Woebot for Substance Use Disorders Phase 1
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020
Arms and Interventions
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Intervention Details:
  • Device: Woebot-SUDs (W-SUDs)
    Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.

Outcome Measures
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Primary Outcome Measures :
  1. The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) [ Time Frame: Change from Baseline to Post-treatment at 12 weeks ]
    The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT.

  2. The Drug Abuse Screening Test 10 (DAST-10) [ Time Frame: Change from Baseline to Post-treatment at 12 weeks ]
    The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco.


Secondary Outcome Measures :
  1. The Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-treatment at 12 weeks ]
    The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment.

  2. Usage Rating Profile Intervention Acceptability Subscale (URPI-usability subscale) [ Time Frame: Post-treatment at 12 weeks ]
    URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.

  3. Usage Rating Profile Intervention Feasibility Subscale (URPI-feasibility subscale) [ Time Frame: Post-treatment at 12 weeks ]
    URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility inquires about factors that impact treatment usage (i.e., intervention quality). Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention feasibility.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All genders
  • 18-65 years
  • Must have access to a smartphone and able to download the W-SUDs app
  • Committed to engage with app and complete assessments
  • Be willing to provide email address (to distribute incentives)
  • Be literate in English (as W-SUDs conversational and video materials will be in English)
  • Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use

Exclusion Criteria:

  • Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  • Suicide attempt or within the past year
  • Drug or alcohol overdose within the past year
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096001


Locations
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United States, California
Woebot Labs Inc
San Francisco, California, United States, 94107
Sponsors and Collaborators
Woebot Labs, Inc.
Stanford University
  Study Documents (Full-Text)

Documents provided by Woebot Labs, Inc.:
Informed Consent Form  [PDF] April 28, 2020

More Information
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Responsible Party: Woebot Labs, Inc.
ClinicalTrials.gov Identifier: NCT04096001    
Other Study ID Numbers: 1R44DA048712-01 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders