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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 : Recruiting
First Posted : September 19, 2019
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Woebot Labs, Inc.

Tracking Information
First Submitted Date September 16, 2019
First Posted Date September 19, 2019
Last Update Posted Date April 21, 2020
Actual Study Start Date January 2, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (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 Same as current
Change History
Current Secondary Outcome Measures
 (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 Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Woebot for Substance Use Disorders
Official Title 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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Men and women between the ages of 18-65 with substance use concerns.
Condition Substance Use Disorders
Intervention 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 Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 17, 2019)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 31, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04096001
Other Study ID Numbers 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
Plan to Share IPD: Undecided
Responsible Party Woebot Labs, Inc.
Study Sponsor Woebot Labs, Inc.
Collaborators Stanford University
Investigators Not Provided
PRS Account Woebot Labs, Inc.
Verification Date September 2019