Clinical trial NCT04974645: Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use
Official title: Pilot: Randomized Controlled Trial of an Digital Therapeutic Versus Education for the Management of Problematic Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Substance Use Disorders
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
name: National Institute on Drug Abuse (NIDA)
First posted: 2021-07-23
Enrollment: 20
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: 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.


Eligibility criteria: Inclusion Criteria:

1. Have a smartphone
2. Endorse a substance use concern
3. Be between 18 and 65 years of age
4. Be available and committed to engage with the Woebot app
5. Be literate in English.(This is required for inclusion because all materials will be in English).

Exclusion Criteria:

1. Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
2. Suicide attempt within the past year (12 months)
3. 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
4. Opioid overdose within the past year (12 months)
5. Opioid misuse without medication-assisted treatment
6. Not residing in the U.S.
7. Ever used Woebot

Primary outcomes:
measure: Change in Number of Substance Use Occasions
timeFrame: 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:
measure: Past Month Average Days Per Week of Drinking Alcohol
timeFrame: 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
measure: Past Month Average Standard Drinks in a Day
timeFrame: 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
measure: Past Month Number of Binge Days
timeFrame: 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
measure: Past Month Average Standard Drinks in a Week
timeFrame: 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
measure: Short Inventory of Problems- Alcohol and Drugs (SIP-AD)
timeFrame: 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
measure: Craving Ratings
timeFrame: 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
measure: Working Alliance Inventory (WAI-SR)
timeFrame: Difference between Mid-treatment at 4 weeks and Post-treatment at 8 weeks
measure: Stanford Presenteeism Scale (SPS-6)
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Thoughts About Abstinence (TAA)
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: CAIR Pandemic Impact Questionnaire (C-PIQ)
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Patient Health Questionnaire (PHQ-8)
timeFrame: 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
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 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
measure: Brief Situational Confidence Questionnaire (BSCQ)
timeFrame: 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
measure: Usage Rating Profile - Intervention (URPI)-Acceptability
timeFrame: Post-treatment (8 weeks from baseline)
measure: Usage Rating Profile Intervention - Intervention (URPI)-Feasibility
timeFrame: Post-treatment (8 weeks from baseline)
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-treatment (8 weeks from baseline)
measure: Number of Participants Indicating Substance Use
timeFrame: Baseline
measure: Number of Participants Providing PEth Sample Phosphatidylethanol (PEth)
timeFrame: Baseline and Post-treatment at 8 weeks
measure: Engagement With Control Condition
timeFrame: Baseline to Post-treatment at 8 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: Woebot Health
state: California
Study officials:
References: