The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use

Study Overview
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Brief Summary
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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 (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.

Detailed Description
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Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation 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 of days abstinent. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control, improves symptoms of depression and anxiety; improves work productivity (i.e. reduce presenteeism/absenteeism); reduces cravings; improves situational confidence to resist substance use.

Official Title
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Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing 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: Digitally-delivered Psychoeducation


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. Previous Woebot use

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: Single


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: Digitally-delivered Psychoeducation<br>Psychoeducation 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: Digitally-delivered Psychoeducation<br>* 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.<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 Follow-up at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Abuse Screening Test (DAST-10) | 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 | 
| 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. | Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks | 
| Stanford Presenteeism Scale (SPS-6) | Measure of workforce productivity. A six item measure derived from a 34 item measure of workforce productivity impacted by health status. The 6-item scale has excellent psychometric properties and has been validated. | Change from Baseline to Post-treatment at 8 weeks | 
| Thoughts About Abstinence (TAA) | Measure of thoughts about abstinence. 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 | 
| Usage Rating Profile - Intervention (URPI)-Acceptability | Measure of acceptability. A 6-item subscale that inquires about intervention acceptability. Responses range from 1 = strongly 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 (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 = strongly 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) | 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) | 
| Short Inventory of Problems- Alcohol and Drugs (SIP-AD) | Measure of substance use problems. 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 Follow-up at 12 weeks | 
| Patient Health Questionnaire (PHQ-8) | 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 Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks | 
| Generalized Anxiety Disorder (GAD-7) | 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 Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks | 
| Brief Situational Confidence Questionnaire (BSCQ) | 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 Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks | 
| Craving Ratings | Measure of craving. A self-reported rating 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 Follow-up at 12 weeks | 
| Quick Drinking Screen (QDS) | Measure of alcohol use. A self-report measure used to assess alcohol use including quantity consumed, frequency of drinking, and binge incidences. | Change from Baseline to Mid-treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to Follow-up at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alcohol Use Disorder, Substance Use Disorder, AUD, SUD, AUD Treatment, SUD Treatment, Smartphone Application, Digital Therapeutic, Alcohol Use Disorder Treatment, Substance Use Disorder Treatment