Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use

Woebot Health2 sites in 1 country20 target enrollmentNovember 3, 2021

ConditionsAlcohol Use Disorder (AUD)Substance Use Disorders

Overview

Phase: N/A
Intervention: Not specified
Conditions: Alcohol Use Disorder (AUD)
Sponsor: Woebot Health
Enrollment: 20
Locations: 2
Primary Endpoint: Change in Number of Substance Use Occasions
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prior to launching a randomized controlled trial, this pilot study will investigate the feasibility and acceptability of the administration of a diagnostic interview and collection of a biomarker test, as well as engagement and preliminary efficacy with W-SUDs and the education arm, among a sample of adults who screen positive for problematic substance use.

Registry

clinicaltrials.gov

Start Date

November 3, 2021

End Date

May 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Woebot Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Have a smartphone
•Endorse a substance use concern
•Be between 18 and 65 years of age
•Be available and committed to engage with the Woebot app
•Be literate in English.(This is required for inclusion because all materials will be in English).

Exclusion Criteria

•Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
•Suicide attempt within the past year (12 months)
•Symptoms of severe drug/alcohol history: History of delirium tremens; Experiencing hypertension, drenching sweats, seizures or confusion after stopping alcohol or drugs; Liver trouble (cirrhosis or hepatitis); Convulsions or GI bleeding due to drug/alcohol use
•Opioid overdose within the past year (12 months)
•Opioid misuse without medication-assisted treatment
•Not residing in the U.S.
•Ever used Woebot

Outcomes

Primary Outcomes

Change in Number of Substance Use Occasions

Time Frame: Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks

Change in number of substance use occasions in the past 30 days

Secondary Outcomes

Working Alliance Inventory (WAI-SR)(Difference between Mid-treatment at 4 weeks and Post-treatment at 8 weeks)
Past Month Average Standard Drinks in a Week(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Short Inventory of Problems- Alcohol and Drugs (SIP-AD)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Stanford Presenteeism Scale (SPS-6)(Change from Baseline to Post-treatment at 8 weeks)
Thoughts About Abstinence (TAA)(Change from Baseline to Post-treatment at 8 weeks)
CAIR Pandemic Impact Questionnaire (C-PIQ)(Change from Baseline to Post-treatment at 8 weeks)
Past Month Average Days Per Week of Drinking Alcohol(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Past Month Number of Binge Days(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Craving Ratings(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Patient Health Questionnaire (PHQ-8)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Past Month Average Standard Drinks in a Day(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Generalized Anxiety Disorder (GAD-7)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Brief Situational Confidence Questionnaire (BSCQ)(Change from Baseline to Mid-Treatment at 4 weeks; Change from Baseline to Post-treatment at 8 weeks; Change from Baseline to 1-Month Follow-up at 12 weeks)
Client Satisfaction Questionnaire (CSQ)(Post-treatment (8 weeks from baseline))
Usage Rating Profile - Intervention (URPI)-Acceptability(Post-treatment (8 weeks from baseline))
Usage Rating Profile Intervention - Intervention (URPI)-Feasibility(Post-treatment (8 weeks from baseline))
Number of Participants Indicating Substance Use(Baseline)
Number of Participants Providing PEth Sample Phosphatidylethanol (PEth)(Baseline and Post-treatment at 8 weeks)
Engagement With Control Condition(Baseline to Post-treatment at 8 weeks)