Woebot for Substance Use Disorders

Study Overview
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Brief Summary
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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.

Official Title
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RCT of Woebot for Substance Use Disorders Phase 1

Conditions
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Substance Use Disorders

Intervention / Treatment
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* Device: Woebot-SUDs (W-SUDs)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Woebot-SUDs (W-SUDs)|Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 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. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks | The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks | The number of days a substance was used the past 30 days | Change from Baseline and Post-treatment at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks | The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction. | Post-treatment at 8 weeks | 
| Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 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. | Post-treatment at 8 weeks | 
| Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 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. | Post-treatment at 8 weeks | 
| Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks | Measure of working alliance. A measure of therapeutic alliance that assesses three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Scores range from 15-60, with higher scores indicating greater alliance. The present study utilized the validated 12-item Short-Revised version (WAI-SR) with minor changes to language, replacing therapist with Woebot. | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks | 
| Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks | Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression. | Change from Baseline to Post-Treatment at 8 weeks | 
| Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks | Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety. | Change from Baseline to Post-Treatment at 8 weeks | 
| Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks | The 8-item BSCQ is a state dependent measure that assesses self-confidence to resist the urge to drink heavily or use drugs in a variety of situations. Each of the 8 scale situations consists of a 100-mm line, anchored by 0% (not at all confident) and 100% (totally confident) where clients are asked to indicate confidence on a scale from 0% to 100%. Higher scores are associated with greater confidence. | Change from Baseline to Post-treatment at 8 weeks | 
| Change Pain Rating From Baseline to Post-Treatment at 8 Weeks | Range from 0-100 (no pain to worst pain imaginable). | Change from Baseline to Post-treatment at 8 weeks |