W-SUDs for COVID-19

NCT ID: NCT04460027

Last Updated: 2022-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2020-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Substance Use Disorders Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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W-SUDs

Group Type EXPERIMENTAL

Woebot Substance Use Disorder

Intervention Type OTHER

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

Wait List Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Woebot Substance Use Disorder

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Woebot Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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4R44DA048712-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

56439

Identifier Type: -

Identifier Source: org_study_id