Clinical trial NCT04925570: The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
Official title: Woebot for Substance Use Disorders Phase 2 RCT: Digitally Delivered Intervention for Reducing Problematic Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder (AUD)
Substance Use Disorders
Keywords: Alcohol Use Disorder
Substance Use Disorder
AUD
SUD
AUD Treatment
SUD Treatment
Smartphone Application
Digital Therapeutic
Alcohol Use Disorder Treatment
Substance Use Disorder Treatment
Lead sponsor: Woebot Health
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2021-06-14
Enrollment: 258
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: 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.

Detailed description: Phase II will evaluate the efficacy of W-SUDs in a large scale RCT relative to a psychoeducation control condition. Primary outcomes will be measures of the quantity and frequency of substance use including number of substance use occasions, heavy drinking days (if applicable) and percent reduction in substance use occasions. Additionally, Phase II will evaluate whether W-SUDs results in a greater reduction in substance-related problems compared to a psychoeducation control group and explore if engagement with W-SUDs, relative to psychoeducation control,

1. improves symptoms of depression and anxiety;
2. improves work productivity (i.e. reduce presenteeism/absenteeism);
3. reduces cravings;
4. improves situational confidence to resist 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. Previous Woebot use

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 Follow-up at 12 weeks
Secondary outcomes:
measure: Drug Abuse Screening Test (DAST-10)
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Working Alliance Inventory (WAI-SR)
timeFrame: 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): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items
timeFrame: Change from Baseline to Post-treatment at 8 weeks
measure: Thoughts About Abstinence (TAA): Goal Item
timeFrame: Baseline and Post-treatment at 8 weeks
measure: Usage Rating Profile - Intervention (URPI)-Acceptability
timeFrame: Post-treatment at 8 weeks
measure: Usage Rating Profile - Intervention (URPI)-Feasibility
timeFrame: Post-treatment at 8 weeks
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment at 8 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 Follow-up at 12 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 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 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 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 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 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 Follow-up at 12 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Judith Prochaska, PhD
role: PRINCIPAL_INVESTIGATOR
References: