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Woebot for Substance Use Disorders

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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.

Tracking Information
First Submitted Date  ICMJE September 16, 2019
First Posted Date  ICMJE September 19, 2019
Last Update Posted Date September 7, 2020
Actual Study Start Date  ICMJE March 26, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Woebot for Substance Use Disorders
Official Title  ICMJE RCT of Woebot for Substance Use Disorders Phase 1
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Prochaska JJ, Vogel EA, Chieng A, Kendra M, Baiocchi M, Pajarito S, Robinson A. A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study. J Med Internet Res. 2021 Mar 23;23(3):e24850. doi: 10.2196/24850.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2020)
108
Original Estimated Enrollment  ICMJE
 (submitted: September 17, 2019)
50
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04096001
Other Study ID Numbers  ICMJE 1R44DA048712-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Woebot Labs, Inc.
Study Sponsor  ICMJE Woebot Labs, Inc.
Collaborators  ICMJE Stanford University
Investigators  ICMJE Not Provided
PRS Account Woebot Labs, Inc.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP