This randomized controlled pilot study will evaluate feasibility, acceptability, and potential efficacy of an app, reSET-O, for patients being started on buprenorphine in acute care settings.
This randomized controlled pilot study will enroll 60 participants, who will be randomly assigned to a treatment as usual (TAU) group or a reSET-O+TAU group after being started on buprenorphine in acute care settings (e.g., emergency department) and referred to community treatment. Study enrollment will last for 3 months after discharge from the acute care setting. Participants in the reSET-O+TAU group will be provided with the reSET-O app and will be encouraged to engage with the app for the 3 months following discharge from the acute care unit. The app works as an extension of cognitive behavioral therapy, providing psychoeducation related to opioid use disorder. All participants will be assessed at study intake and every month during the 3-month intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
The reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse.
Johns Hopkins Bayivew Emergency Department
Baltimore, Maryland, United States
Percentage of approached patients who are eligible for and interested in participation
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Time frame: 3 months
Acceptability as assessed by the Treatment Acceptability Questionnaire
Participant responses to the Treatment Acceptability Questionnaire.
Time frame: 3 months
Acceptability as assessed by the System Usability Scale
Participant responses to the System Usability Scale.
Time frame: 3 months
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge
Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge will be used to assess Treatment Engagement.
Time frame: 30 days
Percentage of drug-negative urine samples during the 3-month intervention
Percentage of drug-negative urine samples during the 3-month intervention will be used to assess Illicit opioid/other drug use.
Time frame: 3 months
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