W-SUDs for COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Woebot for Substance Use Disorders During COVID-19

Conditions
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Substance Use Disorders, Alcohol Use Disorder

Intervention / Treatment
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* Other: Woebot Substance Use Disorder


Participation Criteria
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Eligibility Criteria
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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

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W-SUDs<br> | Other: Woebot Substance Use Disorder<br>* Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.<br>|
| No Intervention: Wait List Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks | Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks | Change from Baseline to Post-treatment at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks | Measure of substance use problems. The SIP-AD assesses substance use problems in the past 30 days. Total score consists of of the sum of all 15 items, ranging from 0-45, where greater scores indicate greater substance use problems. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks | Measure of drug abuse related consequences. The DAST-10 is a brief, 10-item self-report measure that assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity. Adapted from past 12 months to past 30 days. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks | Measure of self-confidence. 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 in Craving Ratings From Baseline to Post-treatment at 8 Weeks | A one-item, self-reported rating of craving intensity to use substances over the past 7 days. Score ranges is from 0-4, where a greater score indicates a more intense urge to use. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks | A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain. | Change from Baseline to Post-treatment at 8 Weeks | 
| Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks | Measure of depression. An 8-item self-report questionnaire that assesses the frequency and severity of depression symptoms. Total scores range from 0 to 24 where higher scores indicate greater levels of depression. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks | Measure of anxiety. A 7-item brief self-report measure used to assess the frequency and severity of anxious thoughts and behaviors over the past 2 weeks. Total score between 0-21, where higher scores indicate greater levels of anxiety. | Change from Baseline to Post-treatment at 8 weeks | 
| Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks | Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact, and growth. Possible total score range from 0-22, where greater scores are related to greater impact. | Change from Baseline to Post-treatment at 8 weeks | 
| Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks | Measure of satisfaction. An 8-item measure used to assess client's satisfaction with treatment on a 4-point scale. Example questions include, How would you rate the quality of service you received? and Did you get the kind of service you wanted? Total sums range from 8-32, with high scores indicating greater satisfaction with the W-SUDs mobile application. | Post-treatment (8 weeks from Baseline) | 
| Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks | Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Total scores range from 6-36, where greater scores indicate greater intervention acceptability. | Post-treatment (8 weeks from Baseline) | 
| Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks | Measure of feasibility. A 6-item subscale that inquires about factors that impact treatment usage (i.e., intervention quality). Total scores range from 6-36, where greater scores indicate greater intervention feasibility. | Post-treatment (8 weeks from Baseline) | 
| Change in 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. Total scores range from 12-60, 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 |