Skip to main content
OpenTrials
Completed

NCT Number: NCT04096001

Woebot for Substance Use Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Woebot Labs Inc

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Woebot-SUDs (W-SUDs)

Device

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.

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Woebot Health

Industry

Collaborators

  • Stanford University

Registry information

Official study title

RCT of Woebot for Substance Use Disorders Phase 1

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.