Phase 2
N=258
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
Alcohol Use Disorder (AUD) · Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04925570 ↗Enrolled (actual)
258
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Number of Substance Use Occasions — -11.3; -11.2; -13.6; -12.9 occasions
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- W-SUDs (Device); Digitally-delivered Psychoeducation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Woebot Health
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Substance Use Occasions |
-11.3; -11.2; -13.6; -12.9; -15.7; -15.4 | — |
| SECONDARY Drug Abuse Screening Test (DAST-10) |
-1.21; -1.95 | — |
| SECONDARY Working Alliance Inventory (WAI-SR) |
14.8; 14.4; 15.2 | — |
| SECONDARY Stanford Presenteeism Scale (SPS-6) |
-5.42; -4.12 | — |
| SECONDARY Thoughts About Abstinence (TAA): Desire to Quit, Expected Success at Quitting, Expected Difficulty of Quitting Items |
0.21; 0.12; 0.42; 0.53; -0.64; -0.28 | — |
| SECONDARY Thoughts About Abstinence (TAA): Goal Item |
10; 12; 25; 22; 14; 9 | — |
| SECONDARY Usage Rating Profile - Intervention (URPI)-Acceptability |
30.1; 30.3 | — |
| SECONDARY Usage Rating Profile - Intervention (URPI)-Feasibility |
28.0; 29.8 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ-8) |
26.9; 28.1 | — |
| SECONDARY Short Inventory of Problems- Alcohol and Drugs (SIP-AD) |
-8.02; -7.39; -9.02; -9.24; -11.5; -10.9 | — |
| SECONDARY Patient Health Questionnaire (PHQ-8) |
-1.84; -1.44; -2.82; -2.05; -2.83; -2.87 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-7) |
-1.31; -1.56; -1.88; -1.72; -2.09; -2.57 | — |
| SECONDARY Brief Situational Confidence Questionnaire (BSCQ) |
7.3; 10.4; 6.77; 11.6; 11.6; 15.6 | — |
| SECONDARY Craving Ratings |
-0.418; -0.56; -0.66; -0.722; -0.816; -0.892 | — |
| SECONDARY Past Month Number of Binge Days |
-4.26; -2.45; -4.09; -2.51; -5.43; -3.14 | — |
| SECONDARY Past Month Average Standard Drinks in a Week |
-7.62; -6.92; -8.67; -8.18; -11.1; -9.43 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Have a smartphone
- Endorse a substance use concern
- Be between 18 and 65 years of age
- Be available and committed to engage with the Woebot app
- Be literate in English. (This is required for inclusion because all materials will be in English).
Exclusion Criteria
- Pregnancy (as W-SUDs will not be specifically developed to address the unique needs of this population)
- Suicide attempt within the past year (12 months)
- 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
- Opioid overdose within the past year (12 months)
- Opioid misuse without medication-assisted treatment
- Not residing in the U.S.
- Previous Woebot use
Data sourced from ClinicalTrials.gov (NCT04925570). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.