Clinical trial NCT04096001: Woebot for Substance Use Disorders
Official title: RCT of Woebot for Substance Use Disorders Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Use Disorders
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2019-09-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline and Post-treatment at 8 weeks
Secondary outcomes:
measure: The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
timeFrame: Post-treatment at 8 weeks
measure: Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
timeFrame: Post-treatment at 8 weeks
measure: Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
timeFrame: Post-treatment at 8 weeks
measure: Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
timeFrame: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
measure: Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
timeFrame: Change from Baseline to Post-Treatment at 8 weeks
measure: Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
timeFrame: Change from Baseline to Post-Treatment at 8 weeks
measure: Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change Pain Rating From Baseline to Post-Treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Woebot Labs Inc
state: California
Study officials:
References:
citation: 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.