Woebot for Substance Use Disorders

• Sponsor: Woebot Labs, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04096001
• Collaborator: Stanford University (Other)
• Enrollment: 101
• Location: 1
• Actual Duration (Months): 5.2
• Patients Per Site Per Month: 19.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders	Device: Woebot-SUDs (W-SUDs)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: RCT of Woebot for Substance Use Disorders Phase 1
• Actual Study Start Date: Mar 26, 2020
• Actual Primary Completion Date: Aug 31, 2020
• Actual Study Completion Date: Aug 31, 2020

Outcome Measures

Primary Outcome Measures

1. The Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) [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.

2. The Drug Abuse Screening Test 10 (DAST-10) [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.

Secondary Outcome Measures

1. The Client Satisfaction Questionnaire (CSQ-8) [Post-treatment at 12 weeks]

   The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment.

2. Usage Rating Profile Intervention Acceptability Subscale (URPI-usability subscale) [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.

3. Usage Rating Profile Intervention Feasibility Subscale (URPI-feasibility subscale) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woebot Labs Inc	San Francisco	California	United States	94107

Sponsors and Collaborators

• Woebot Labs, Inc.
• Stanford University

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Apr 28, 2020

More Information

Publications

None provided.

• Responsible Party: Woebot Labs, Inc.
• ClinicalTrials.gov Identifier: NCT04096001
• Other Study ID Numbers: 1R44DA048712-01
• First Posted: Sep 19, 2019
• Last Update Posted: Jul 26, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

No Results Posted as of Jul 26, 2021