Woebot for Substance Use Disorders

Substance Use Disorders Clinical Trial

Official title:

RCT of Woebot for Substance Use Disorders Phase 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04096001
• Other study ID #: 1R44DA048712-01
• Status: Completed
• Phase: Phase 1
• Start date: March 26, 2020
• Est. completion date: August 31, 2020

Study information

• Verified date: August 2022
• Source: Woebot Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related 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.

Locations

Country	Name	City	State
United States	Woebot Labs Inc	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Woebot Labs, Inc.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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