NCT04925570

Brief Summary

This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder program (W-SUDs) to reduce substance use relative to a psychoeducation control condition, which has no cognitive behavioral therapy and the content is not delivered through a conversational user interface.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
258

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

November 14, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2023

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 24, 2024

Completed
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

9 months

First QC Date

May 25, 2021

Results QC Date

February 20, 2024

Last Update Submit

October 21, 2024

Conditions

Alcohol Use Disorder (AUD)Substance Use Disorders

Keywords

Alcohol Use DisorderSubstance Use DisorderAUDSUDAUD TreatmentSUD TreatmentSmartphone ApplicationDigital TherapeuticAlcohol Use Disorder TreatmentSubstance Use Disorder Treatment

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 Follow-up at 12 weeks

Secondary Outcomes (15)

  • Drug Abuse Screening Test (DAST-10)

    Change from Baseline to Post-treatment at 8 weeks

  • Working Alliance Inventory (WAI-SR)

    Post-treatment at 8 weeks

  • Stanford Presenteeism Scale (SPS-6)

    Change from Baseline to Post-treatment at 8 weeks

  • Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items

    Change from Baseline to Post-treatment at 8 weeks

  • Thoughts About Abstinence (TAA): Goal Item

    Baseline and Post-treatment at 8 weeks

  • +10 more secondary outcomes

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 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-SUDsDEVICE

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 PsychoeducationOTHER

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • Previous Woebot use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

Related Publications (2)

  • Moore JB, Chieng A, Pirner MC, Pajarito S, Vogel EA, Bowdring MA, Bullard L, Robinson A, Prochaska JJ. Mitigating fraud in a fully decentralized clinical trial of a digital health intervention. Ann Behav Med. 2025 Jan 4;59(1):kaaf047. doi: 10.1093/abm/kaaf047.

    PMID: 40548528DERIVED

  • Prochaska JJ, Vogel EA, Chieng A, Baiocchi M, Pajarito S, Pirner M, Darcy A, Robinson A. A relational agent for treating substance use in adults: Protocol for a randomized controlled trial with a psychoeducational comparator. Contemp Clin Trials. 2023 Apr;127:107125. doi: 10.1016/j.cct.2023.107125. Epub 2023 Feb 20.

    PMID: 36813084DERIVED

MeSH Terms

Conditions

AlcoholismSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersChemically-Induced DisordersMental 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

Study Officials

  • Judith Prochaska, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2021

First Posted

June 14, 2021

Study Start

November 14, 2022

Primary Completion

August 17, 2023

Study Completion

August 17, 2023

Last Updated

October 24, 2024

Results First Posted

October 24, 2024

Record last verified: 2024-10

Locations

US(1)