Woebot for Substance Use Disorders

RCT of Woebot for Substance Use Disorders Phase 1

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders
• Intervention / Treatment: Device: Woebot-SUDs (W-SUDs)

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Woebot Labs Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks	The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction.	Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 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.	Post-treatment at 8 weeks
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 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.	Post-treatment at 8 weeks
Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks	Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 15-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing "therapist" with "Woebot".	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	Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.	Change from Baseline to Post-Treatment at 8 weeks
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks	Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.	Change from Baseline to Post-Treatment at 8 weeks
Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks	The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% ("not at all confident") and 100% ("totally confident") where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence.	Change from Baseline to Post-treatment at 8 weeks
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks	Range from 0-100 (no pain to worst pain imaginable).	Change from Baseline to Post-treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Woebot Health
• Collaborators: Stanford University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2020
• Primary Completion (Actual): August 31, 2020
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): August 31, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 1R44DA048712-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No