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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096001
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
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
Substance Use Disorders Device: Woebot-SUDs (W-SUDs)

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: RCT of Woebot for Substance Use Disorders Phase 1
Estimated Study Start Date : January 2, 2020
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 30, 2020
Groups and Cohorts
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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
Sampling Method:   Non-Probability Sample
Study Population
Men and women between the ages of 18-65 with substance use concerns.
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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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 19, 2019
Last Verified: September 2019
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