Phase 1
N=180
W-SUDs for COVID-19
Substance Use Disorders · Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04460027 ↗Enrolled (actual)
180
Serious AEs
0.6%
Results posted
Dec 2022
Primary outcome: Primary: Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks — -9.1; -4.7 occasions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Woebot Substance Use Disorder (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Woebot Health
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks |
-9.1; -4.7 | — |
| SECONDARY Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks |
-5.3; -4.7 | — |
| SECONDARY Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks |
1.3; 2.2 | — |
| SECONDARY Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks |
11.8; 5.3 | — |
| SECONDARY Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks |
-.5; -.4 | — |
| SECONDARY Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks |
-5.1; -.8 | — |
| SECONDARY Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks |
-1.6; -1.7 | — |
| SECONDARY Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks |
-1.6; -.7 | — |
| SECONDARY Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks |
-1.8; -1.4 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks |
25.5 | — |
| SECONDARY Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks |
29.0 | — |
| SECONDARY Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks |
32.0 | — |
| SECONDARY Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks |
44.0 | — |
Summary
The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic.
This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.
Eligibility Criteria
Inclusion Criteria
- All genders aged 18-65 years
- Access to a smartphone
- Available and committed to engage with app and complete assessments
- Be willing to provide email address (as this is how assessment incentives will be distributed),
- Literate in English (as W-SUDs conversational and video materials will be in English).
Exclusion Criteria
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- History of severe drug/alcohol use
- History of opioid misuse without medication-assisted treatment
- Suicide attempt within the past year
- Opioid overdose within the past year
Data sourced from ClinicalTrials.gov (NCT04460027). 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.