Digital Therapeutic vs Education for the Management of Problematic Substance Use
Study Details
Study Description
Brief Summary
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to an education-only control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to an education-only control condition. Primary outcomes will be measures of the quantity and frequency of substance use including, number of substance use occasions, heavy drinking days (if applicable) and percent days abstinent. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to an Education
Only control group and explore:
If engagement with W-SUDs, relative to education-only control,
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improves symptoms of depression and anxiety;
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improves work productivity (i.e. reduce presenteeism/absenteeism);
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reduces cravings;
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improves situational confidence.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: W-SUDs Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving. |
Device: W-SUDs
Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
|
| Sham Comparator: Education Only Education Only delivers weekly fact sheets that include information on: Alcohol-specific topics; Drug-specific topics; General addiction topics; Statistics relating to alcohol and substance use. |
Other: Education Only
The education only control intervention is a form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.
|
Outcome Measures
Primary Outcome Measures
- Quick Drinking Screen (QDS) [Change from Baseline to Post-treatment at 8 weeks]
Alcohol Quantity/Frequency/Binge
- Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
Secondary Outcome Measures
- Michigan Alcohol Screening Test (MAST) [Baseline]
- CAGE Adapted to Include Drug USE (CAGE-AID) [Baseline]
- Psychosis Screening Questionnaire (PSQ) [Baseline]
- Demographics [Baseline]
Age, Ethnicity, Race, Marital Status, Education, Gender identity, Sexual Identity
- Drug Abuse Screening Test (DAST-10) [Baseline]
- Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (AUDADIS-V)(AUDIT-C) [Baseline]
- Mini-International Neuropsychiatric Interview (MINI) [Baseline]
- Working Alliance Inventory (WAI-SR) [Difference between mid-treatment at 4 weeks and post-treatment at 8 weeks]
- Quick Drinking Screen (QDS) [Change from Baseline to Post-treatment at 8 weeks]
- Stanford Presenteeism Scale (SPS-6) [Change from Baseline to Post-treatment at 8 weeks]
- Thoughts About Abstinence (TAA) [Change from Baseline to Post-treatment at 8 weeks]
- CAIR Pandemic Impact Questionnaire (C-PIQ) [Change from Baseline to Post-treatment at 8 weeks]
- Tobacco Use [Change from Baseline to Post-treatment at 8 weeks]
- Usage Rating Profile Intervention (URPI) [Post-treatment (8 weeks from baseline)]
- Client Satisfaction Questionnaire (CSQ) [Post-treatment (8 weeks from baseline)]
- Short Inventory of Problems- Alcohol and Drugs (SIP-AD) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
- Phosphatidylethanol (PEth) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks]
- Patient Health Questionnaire (PHQ-8) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
- Generalized Anxiety Disorder (GAD-7) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
- Brief Situational Confidence Questionnaire (BSCQ) [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
- Craving Ratings [Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have a smartphone
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Endorse a substance use concern
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Be between 18 and 65 years of age
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Be available and committed to engage with the Woebot app
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Be literate in English.(This is required for inclusion because all materials will be in English).
Exclusion Criteria:
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Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
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Suicide attempt within the past year (12 months)
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Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
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Opioid overdose within the past year (12 months)
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Opioid misuse without medication-assisted treatment
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Not residing in the U.S.
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Ever used Woebot
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Woebot Labs, Inc.
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 58725