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Woebot for Substance Use Disorders

Primary Purpose

Substance Use Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Woebot-SUDs (W-SUDs)
Sponsored by
Woebot Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Woebot Labs Inc

Outcomes

Primary Outcome Measures

Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) 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.
Change in The Drug Abuse Screening Test 10 (DAST-10) 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.
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
The number of days a substance was used the past 30 days

Secondary Outcome Measures

The Client Satisfaction Questionnaire (CSQ-8) at 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.
Usage Rating Profile Intervention (URPI) - Acceptability at 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.
Usage Rating Profile Intervention (URPI) - Feasibility at 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.
Change From 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. 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".
Change Patient Health Questionnaire (PHQ-8) 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.
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
Measure of anxiety. Total score between 0-21, where higher scores indicate greater levels of anxiety.
Change Brief Situational Confidence Questionnaire (BSCQ) 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.
Change Pain Rating From Baseline to Post-Treatment at 8 Weeks
Range from 0-100 (no pain to worst pain imaginable).

Full Information

First Posted
September 16, 2019
Last Updated
August 8, 2022
Sponsor
Woebot Health
Collaborators
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT04096001
Brief Title
Woebot for Substance Use Disorders
Official Title
RCT of Woebot for Substance Use Disorders Phase 1
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 26, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Woebot Health
Collaborators
Stanford University

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Woebot-SUDs (W-SUDs)
Intervention Description
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 Outcome Measure Information:
Title
Change in Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in The Drug Abuse Screening Test 10 (DAST-10) From Baseline to Post-treatment at 8 Weeks
Description
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.
Time Frame
Change from Baseline to Post-treatment at 8 weeks
Title
Change in Number of Days Substance Use From Baseline to Post-treatment at 8 Weeks
Description
The number of days a substance was used the past 30 days
Time Frame
Change from Baseline and Post-treatment at 8 weeks
Secondary Outcome Measure Information:
Title
The Client Satisfaction Questionnaire (CSQ-8) at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment at 8 weeks
Title
Usage Rating Profile Intervention (URPI) - Acceptability at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment at 8 weeks
Title
Usage Rating Profile Intervention (URPI) - Feasibility at Post-treatment at 8 Weeks
Description
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.
Time Frame
Post-treatment at 8 weeks
Title
Change From 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. 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".
Time Frame
Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
Title
Change Patient Health Questionnaire (PHQ-8) From Baseline to Post-Treatment at 8 Weeks
Description
Measure of depression severity. Total score between 0-27, where higher scores indicate greater levels of depression.
Time Frame
Change from Baseline to Post-Treatment at 8 weeks
Title
Change Generalized Anxiety Disorder (GAD-7) From Baseline to Post-Treatment at 8 Weeks
Description
Measure of anxiety. 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 Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-Treatment at 8 Weeks
Description
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 Pain Rating From Baseline to Post-Treatment at 8 Weeks
Description
Range from 0-100 (no pain to worst pain imaginable).
Time Frame
Change from Baseline 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 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
Facility Information:
Facility Name
Woebot Labs Inc
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33755028
Citation
Prochaska JJ, Vogel EA, Chieng A, Kendra M, Baiocchi M, Pajarito S, Robinson A. A Therapeutic Relational Agent for Reducing Problematic Substance Use (Woebot): Development and Usability Study. J Med Internet Res. 2021 Mar 23;23(3):e24850. doi: 10.2196/24850.
Results Reference
derived

Learn more about this trial

Woebot for Substance Use Disorders

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