Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

NCT04974645 | Completed Results DMC

• 1 other identifier: 62053
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Use Disorder (AUD); Substance Use Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Number of Substance Use Occasions

  Change in number of substance use occasions in the past 30 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

Secondary Outcomes (19)

• 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 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

• 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

• 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

Study Arms (2)

W-SUDs

EXPERIMENTAL

Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.

Device: W-SUDs

Digitally-delivered Psychoeducation

OTHER

Psychoeducation digitally delivers weekly fact sheets that include information on: 1. Alcohol-specific topics; 2. Drug-specific topics; 3. General addiction topics; 4. Statistics relating to alcohol and substance use.

Other: Digitally-delivered Psychoeducation

Interventions

W-SUDs DEVICE

Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.

W-SUDs

Digitally-delivered Psychoeducation OTHER

A form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.

Digitally-delivered Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Woebot Health: lead
• Stanford University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Stanford University

Palo Alto, California, 94306, United States

Location

Woebot Health

San Francisco, California, 94103, United States

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Judith J. Prochaska, PhD, MPH
• Organization: Stanford Prevention Research Center, Department of Medicine, Stanford

jpro@stanford.edu

650-724-3608

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 23, 2021
• Study Start: November 3, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2024-01

Locations

US (2)