Back to resultsW-SUDs for COVID-19
Primary Purpose
Substance Use Disorders, Alcohol Use Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Woebot Substance Use Disorder
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
W-SUDs
Wait List Control
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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 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 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 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 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 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 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 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.
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.
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.
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.
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".
Full Information
NCT ID
NCT04460027
First Posted
July 1, 2020
Last Updated
November 23, 2022
Sponsor
Woebot Health
Collaborators
Stanford University, National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04460027
Brief Title
W-SUDs for COVID-19
Official Title
Woebot for Substance Use Disorders During COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Stanford University, National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Alcohol Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
W-SUDs
Arm Type
Experimental
Arm Title
Wait List Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Woebot Substance Use Disorder
Intervention Description
Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
Primary Outcome Measure Information:
Title
Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
Description
Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Secondary Outcome Measure Information:
Title
Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
Description
A one item, self-reported rating of pain. Scores range from 0-100 where higher scores indicate greater levels of pain.
Time Frame
Change from Baseline to Post-treatment at 8 Weeks
Title
Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment (8 weeks from Baseline)
Title
Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment (8 weeks from Baseline)
Title
Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment (8 weeks from Baseline)
Title
Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
Description
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".
Time Frame
Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
12. IPD Sharing Statement
Learn more about this trial
W-SUDs for COVID-19
We'll reach out to this number within 24 hrs