Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Study Overview
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Brief Summary
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Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.

Official Title
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Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use

Conditions
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Alcohol Use Disorder (AUD), Substance Use Disorders

Intervention / Treatment
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* Device: W-SUDs
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a smartphone Endorse a substance use concern Be between 18 and 65 years of age Be available and committed to engage with the Woebot app Be literate in English.(This is required for inclusion because all materials will be in English). Exclusion Criteria: Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population) Suicide attempt within the past year (12 months) 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 Opioid overdose within the past year (12 months) Opioid misuse without medication-assisted treatment Not residing in the U.S. Ever used Woebot

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W-SUDs<br>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<br>* Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.<br>|
| Other: Education<br>Education digitally 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<br>* The education arm will receive digitally delivered 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of substance use occasions | Number of substance use occasions in the past 30 days | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Drinking Screen (QDS) | Alcohol Quantity/Frequency/Binge | 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 | 
| Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | The SIP-AD assesses substance use problems in the past 30 days. The scored variables, total scores and 15-item mean, summarize consequences of alcohol and drug use. Scores range from 0-45, where greater scores indicate greater substance use problems. | 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 | Self-reported ratings of craving intensity | 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 | 
| Working Alliance Inventory (WAI-SR) | 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 5-20, 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. | Difference between mid-treatment at 4 weeks and post-treatment at 8 weeks | 
| Stanford Presenteeism Scale (SPS-6) | A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric propertiesand has been validated. | Change from Baseline to Post-treatment at 8 weeks | 
| Thoughts About Abstinence (TAA) | Modified for alcohol and substances. 5-item questionnaire assessing desire to quit, expected success at quitting, expected difficulty of quitting, and confidence in ability to quit measured on 10-point Likert scales. The fifth item assesses partcipants' abstinence goal. | Change from Baseline to Post-treatment at 8 weeks | 
| CAIR Pandemic Impact Questionnaire (C-PIQ) | Assesses impact of the COVID-19 pandemic in terms of exposure to stressors, mental health impact and growth | Change from Baseline to Post-treatment at 8 weeks | 
| Patient Health Questionnaire (PHQ-8) | Total score between 0-27, higher scores indicate greater levels of depression. | 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) | Total score between 0-21, higher scores indicate greater levels of anxiety | 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) | 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 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 | 
| Usage Rating Profile - Intervention (URPI)-Acceptability | Measure of acceptability. A 6-item subscale that 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 (8 weeks from baseline) | 
| Usage Rating Profile Intervention - Intervention (URPI)-Feasibility | Measure of feasibility. A 6-item subscale that 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 (8 weeks from baseline) | 
| Client Satisfaction Questionnaire (CSQ) | Range from 8 to 32, with higher values indicating higher satisfaction | Post-treatment (8 weeks from baseline) | 
| Mini-International Neuropsychiatric Interview (MINI) | A clinical interview used to assess a substance use diagnosis | Baseline | 
| Phosphatidylethanol (PEth) | PEth is an alcohol biomarker, where a positive result is an indication of alcohol exposure during the 2-4 weeks prior to specimen collection. | Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline from12 weeks | 
| Engagement with control condition | Assessment of number of emails opened duration of study | Baseline to Post-treatment at 8 weeks |