W-SUDs for COVID-19

Alcohol Use Disorder Clinical Trial

Official title:

Woebot for Substance Use Disorders During COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460027
• Other study ID #: 56439
• Secondary ID: 4R44DA048712-02
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2020
• Est. completion date: November 30, 2020

Study information

• Verified date: November 2022
• Source: Woebot Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Disease
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• Woebot Substance Use Disorder
Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (3)

Lead Sponsor	Collaborator
Woebot Health	National Institute on Drug Abuse (NIDA), Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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