W-SUDs for COVID-19

Phase 1

Completed

Conditions: Alcohol Use Disorder
Substance Use Disorders

Interventions: Other: Woebot Substance Use Disorder

Registration Number: NCT04460027

Lead Sponsor: Woebot Health

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 180

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
W-SUDs	Woebot Substance Use Disorder	-

Primary Outcome Measures

Name	Time	Method
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	Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks	Change 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 in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks	Change 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 in Craving Ratings From Baseline to Post-treatment at 8 Weeks	Change 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 in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks	Change 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 in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks	Change 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 in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks	Change 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 in Pain Ratings From Baseline to Post-treatment at 8 Weeks	Change 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.
Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks	Post-treatment (8 weeks from Baseline)	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.
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks	Post-treatment (8 weeks from Baseline)	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.
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks	Post-treatment (8 weeks from Baseline)	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.
Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks	Change 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 in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks	Change 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.