Pilot: Digital Therapeutic vs Education for the Management of Problematic Substance Use

Woebot Health

Status: Completed

Conditions: Alcohol Use Disorder (AUD); Substance Use Disorders

Treatments: Other: Digitally-delivered Psychoeducation; Device: W-SUDs

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04974645

62053

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

W-SUDs

Experimental group

Description:

Woebot (W-SUDs), a Conversational Agent (CA) instantaneously available 24 hours per day, 7 days per week, 'checks in' with users. Using conversational tones, it encourages mood tracking and delivers general psychoeducation as well as tailored empathy, cognitive behavior therapy (CBT)-based behavior change tools, and behavioral pattern insight. Woebot's app-based platform and user-centered design philosophy makes it an optimal modality for Substance Use Disorders (SUD) treatment delivery. It offers immediate, evidence-based tailored support in the patient's peak moment of craving.

Treatment:

Device: W-SUDs

Digitally-delivered Psychoeducation

Other group

Description:

Psychoeducation digitally delivers weekly fact sheets that include information on: 1. Alcohol-specific topics; 2. Drug-specific topics; 3. General addiction topics; 4. Statistics relating to alcohol and substance use.

Treatment:

Other: Digitally-delivered Psychoeducation