Woebot for Substance Use Disorders
RCT of Woebot for Substance Use Disorders Phase 1
1 other identifier
interventional
101
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedStudy Start
First participant enrolled
March 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedResults Posted
Study results publicly available
August 31, 2022
CompletedAugust 31, 2022
August 1, 2022
5 months
September 16, 2019
April 28, 2022
August 8, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 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 AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Change from Baseline to Post-treatment at 8 weeks
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.
Change from Baseline to Post-treatment at 8 weeks
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
The number of days a substance was used the past 30 days
Change from Baseline and Post-treatment at 8 weeks
Secondary Outcomes (8)
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
Post-treatment at 8 weeks
Change From 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 Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
Change from Baseline to Post-Treatment at 8 weeks
- +3 more secondary outcomes
Interventions
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.
Eligibility Criteria
You may qualify if:
- All genders
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Woebot Healthlead
- Stanford Universitycollaborator
Study Sites (1)
Woebot Labs Inc
San Francisco, California, 94107, United States
Related Publications (1)
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.
PMID: 33755028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Judith J Prochaska, PhD
- Organization
- Stanford Prevention Research Center, School of Medicine, Stanford University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2019
First Posted
September 19, 2019
Study Start
March 26, 2020
Primary Completion
August 31, 2020
Study Completion
August 31, 2020
Last Updated
August 31, 2022
Results First Posted
August 31, 2022
Record last verified: 2022-08