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Woebot for Substance Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096001
Recruitment Status : Completed
First Posted : September 19, 2019
Results First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Woebot Health

Study Description
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Brief Summary:
Phase 1 of this study aims to develop a digitally-delivered substance use disorder program through the Woebot app-based platform (W-SUDs) and evaluate the effectiveness of, patient satisfaction with and the acceptability of W-SUDs as a substance use management tool.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Device: Woebot-SUDs (W-SUDs) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RCT of Woebot for Substance Use Disorders Phase 1
Actual Study Start Date : March 26, 2020
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020
Arms and Interventions
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Intervention Details:
  • Device: Woebot-SUDs (W-SUDs)
    Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.

Outcome Measures
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Primary Outcome Measures :
  1. Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-treatment at 8 weeks ]
    The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.

  2. Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-treatment at 8 weeks ]
    The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. The range is 0-10, where higher scores indicate greater severity.

  3. Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks [ Time Frame: Change from Baseline and Post-treatment at 8 weeks ]
    The number of days a substance was used the past 30 days


Secondary Outcome Measures :
  1. The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks [ Time Frame: Post-treatment at 8 weeks ]
    The CSQ-8 is an 8-item self-report scale measuring satisfaction with treatment. Scores from 8 to 32, with higher values indicating higher satisfaction.

  2. Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks [ Time Frame: Post-treatment at 8 weeks ]
    URPI-Acceptability Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Acceptability inquires about intervention acceptability. Responses range from 1= "slightly disagree" to 6="strongly agree". Scores are averages, with greater scores indicating greater intervention acceptability.

  3. Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks [ Time Frame: Post-treatment at 8 weeks ]
    URPI-Feasibility Subscale is 6-item subscale from the URP Intervention Revised (URP-IR) scale. The URPI-Feasibility 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.

  4. Change From Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks [ Time Frame: 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. Scores range from 15-60, 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".

  5. Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-Treatment at 8 weeks ]
    Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.

  6. Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-Treatment at 8 weeks ]
    Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.

  7. Change Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-treatment at 8 weeks ]
    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.

  8. Change Pain Rating From Baseline to Post-Treatment at 8 Weeks [ Time Frame: Change from Baseline to Post-treatment at 8 weeks ]
    Range from 0-100 (no pain to worst pain imaginable).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All genders
  • 18-65 years
  • Must have access to a smartphone and able to download the W-SUDs app
  • Committed to engage with app and complete assessments
  • Be willing to provide email address (to distribute incentives)
  • Be literate in English (as W-SUDs conversational and video materials will be in English)
  • Endorse a substance use concern according to the DAST-10 and/or AUDIT-C scale cutoffs for problematic use

Exclusion Criteria:

  • Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  • Suicide attempt or within the past year
  • Drug or alcohol overdose within the past year
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096001


Locations
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United States, California
Woebot Labs Inc
San Francisco, California, United States, 94107
Sponsors and Collaborators
Woebot Health
Stanford University
  Study Documents (Full-Text)

Documents provided by Woebot Health:
Study Protocol  [PDF] March 24, 2020
Statistical Analysis Plan  [PDF] March 23, 2021
Informed Consent Form  [PDF] April 28, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Woebot Health
ClinicalTrials.gov Identifier: NCT04096001    
Other Study ID Numbers: 1R44DA048712-01 ( U.S. NIH Grant/Contract )
First Posted: September 19, 2019    Key Record Dates
Results First Posted: August 31, 2022
Last Update Posted: August 31, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders