Phase 1
N=101
Woebot for Substance Use Disorders
Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04096001 ↗Enrolled (actual)
101
Serious AEs
1.0%
Results posted
Aug 2022
Primary outcome: Primary: Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks — -9.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Woebot-SUDs (W-SUDs) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Woebot Health
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks |
-9.3 | — |
| PRIMARY Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks |
-1.2 | — |
| PRIMARY Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks |
-9.3 | — |
| SECONDARY The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks |
23.2 | — |
| SECONDARY Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks |
25.6 | — |
| SECONDARY Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks |
28.5 | — |
| SECONDARY Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks |
40.8 | — |
| SECONDARY Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks |
8.6 | — |
| SECONDARY Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks |
-2.3 | — |
| SECONDARY Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks |
16.9 | — |
| SECONDARY Change Pain Rating From Baseline to Post-Treatment at 8 Weeks |
24.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04096001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.