Pilot Study of reSET-O to Treatment-as-usual in Acute Care Settings
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid-use Disorder
- Sponsor
- Johns Hopkins University
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Acceptability as assessed by the System Usability Scale
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18-65 years old
- •Opioid use disorder
- •Eligible for buprenorphine treatment
- •Has reSET-O compatible mobile device
Exclusion Criteria
- •Pregnancy
- •Significant psychiatric comorbidity
Outcomes
Primary Outcomes
Acceptability as assessed by the System Usability Scale
Time Frame: 3 months
Participant responses to the System Usability Scale.
Percentage of approached patients who are eligible for and interested in participation
Time Frame: 3 months
Percentage of approached patients who are eligible for and interested in participation will be used to assess feasibility.
Acceptability as assessed by the Treatment Acceptability Questionnaire
Time Frame: 3 months
Participant responses to the Treatment Acceptability Questionnaire.
Secondary Outcomes
- Percentage of drug-negative urine samples during the 3-month intervention(3 months)
- Attendance at follow-up appointment for on-going buprenorphine treatment within 30 days of discharge(30 days)