Clinical trial NCT04460027: W-SUDs for COVID-19
Official title: Woebot for Substance Use Disorders During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance Use Disorders
Alcohol Use Disorder
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-07-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Number of Substance Use Occasions in the Past 30 Days From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
Secondary outcomes:
measure: Change in Short Inventory of Problems - Alcohol and Drugs (SIP-AD) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in Drug Abuse Screening Test (DAST-10) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in Brief Situational Confidence Questionnaire (BSCQ) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in Craving Ratings From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in Pain Ratings From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 Weeks
measure: Change in Patient Health Questionnaire-8 (PHQ-8) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in General Anxiety Disorder (GAD-7) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Change in CAIR Pandemic Impact Questionnaire (CAIR-PIQ) From Baseline to Post-treatment at 8 Weeks
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Client Satisfaction Questionnaire (CSQ) at Post-treatment at 8 Weeks
timeFrame: Post-treatment (8 weeks from Baseline)
measure: Usage Rating Profile - Intervention (URPI)-Acceptability at Post-treatment at 8 Weeks
timeFrame: Post-treatment (8 weeks from Baseline)
measure: Usage Rating Profile - Intervention (URPI)-Feasibility at Post-treatment at 8 Weeks
timeFrame: Post-treatment (8 weeks from Baseline)
measure: Change in Working Alliance Inventory (WAI-SR) From Mid-treatment at 4 Weeks to Post-treatment at 8 Weeks
timeFrame: Change from Mid-treatment at 4 weeks to Post-treatment at 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
References: