NCT04460027

Brief Summary

The purpose of this study is to test the efficacy of a substance use disorder intervention delivered via a mobile application in an adult population during the COVID-19 pandemic. This study that will test the comparative efficacy of the mobile-app based substance use disorder program to reduce substance use relative to a wait list control condition, and explore between group differences on quality of life indices as well as retention and engagement during COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

June 22, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 21, 2022

Completed
Last Updated

December 21, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

July 1, 2020

Results QC Date

July 19, 2022

Last Update Submit

November 23, 2022

Conditions

Substance Use DisordersAlcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks

    Change in number of substance use occasions in the past 30 days from Baseline to Post-treatment at 8 weeks

    Change from Baseline to Post-treatment at 8 weeks

Secondary Outcomes (12)

  • Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks

    Change from Baseline to Post-treatment at 8 weeks

  • Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks

    Change from Baseline to Post-treatment at 8 weeks

  • Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks

    Change from Baseline to Post-treatment at 8 weeks

  • Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks

    Change from Baseline to Post-treatment at 8 weeks

  • Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks

    Change from Baseline to Post-treatment at 8 Weeks

  • +7 more secondary outcomes

Study Arms (2)

W-SUDs

EXPERIMENTAL
Other: Woebot Substance Use Disorder

Wait List Control

NO INTERVENTION

Interventions

Woebot Substance Use DisorderOTHER

Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.

W-SUDs

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All genders aged 18-65 years
  • Access to a smartphone
  • Available and committed to engage with app and complete assessments
  • Be willing to provide email address (as this is how assessment incentives will be distributed),
  • Literate in English (as W-SUDs conversational and video materials will be in English).

You may not qualify if:

  • Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
  • History of severe drug/alcohol use
  • History of opioid misuse without medication-assisted treatment
  • Suicide attempt within the past year
  • Opioid overdose within the past year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Results Point of Contact

Title
Judith J. Prochaska, PhD
Organization
Stanford Prevention Research Center, Department of Medicine, Stanford University
jpro@stanford.edu
650-724-3608

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

July 7, 2020

Study Start

June 22, 2020

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

December 21, 2022

Results First Posted

December 21, 2022

Record last verified: 2022-11

Locations

US(1)