N/A
N=20
Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use
Alcohol Use Disorder (AUD) · Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04974645 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Change in Number of Substance Use Occasions — -0.6; -7.2; -3.9; -6.7 occasions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- W-SUDs (Device); Digitally-delivered Psychoeducation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Woebot Health
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Substance Use Occasions |
-0.6; -7.2; -3.9; -6.7; -4.9; -6.6 | — |
| SECONDARY Past Month Average Days Per Week of Drinking Alcohol |
-0.4; -2.4; -0.2; -1.6; -0.6; -1.4 | — |
| SECONDARY Past Month Average Standard Drinks in a Day |
1.6; -1.0; -0.3; -1.1; -2.4; -0.8 | — |
| SECONDARY Past Month Number of Binge Days |
4; -1.3; 2.0; -7.4; -3.7; -4.1 | — |
| SECONDARY Past Month Average Standard Drinks in a Week |
8.2; -8.0; -2.3; -6.7; -10.3; -4.6 | — |
| SECONDARY Short Inventory of Problems- Alcohol and Drugs (SIP-AD) |
-7.6; -1.1; -7.4; -4.0; -9.6; -4.4 | — |
| SECONDARY Craving Ratings |
-0.1; 0.0; -0.3; -0.1; -0.3; -0.3 | — |
| SECONDARY Working Alliance Inventory (WAI-SR) |
0.14; 0.57; 1.57 | — |
| SECONDARY Stanford Presenteeism Scale (SPS-6) |
2.3; 2.7 | — |
| SECONDARY Thoughts About Abstinence (TAA) |
-0.8; 1.4; 0.4; -0.8; 0.6; -0.6 | — |
| SECONDARY CAIR Pandemic Impact Questionnaire (C-PIQ) |
-1.1; 0.1; -2.8; -1.3 | — |
| SECONDARY Patient Health Questionnaire (PHQ-8) |
-3.9; -2.0; -1.9; -1.2; -1.4; -2.9 | — |
| SECONDARY Generalized Anxiety Disorder (GAD-7) |
-3.4; 0.6; -0.6; -0.2; -2.7; 0.6 | — |
| SECONDARY Brief Situational Confidence Questionnaire (BSCQ) |
10.9; 20.7; 10.9; 18.9; 9.2; 20.7 | — |
| SECONDARY Usage Rating Profile - Intervention (URPI)-Acceptability |
24.1; 27.4 | — |
| SECONDARY Usage Rating Profile Intervention - Intervention (URPI)-Feasibility |
27.4; 34.2 | — |
| SECONDARY Client Satisfaction Questionnaire (CSQ) |
23.4; 26.1 | — |
| SECONDARY Number of Participants Indicating Substance Use |
0; 1; 1; 2; 4; 3 | — |
| SECONDARY Number of Participants Providing PEth Sample Phosphatidylethanol (PEth) |
5; 5; 3; 4 | — |
| SECONDARY Engagement With Control Condition |
6.7 | — |
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
- 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.
- Ever used Woebot
Data sourced from ClinicalTrials.gov (NCT04974645). 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.