Comprehensive CBT (Cognitive Behavioral Therapy) Via Reset for a Hub and Spoke MAT (Medication Assisted Treatment) System of Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Retention in treatment on MAT for 6 months after enrolling in the study
Study Overview
Brief Summary
This research is being done to find out whether an app based cognitive behavior therapy called reSET improves the adherence to and outcome of buprenorphine treatment for opioid use disorder (OUD) in the setting of a Hub and Spoke implementation system.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
N/A at this time. This trial is a pilot study seeking an N of 15 participants. All participants will be assigned the "treatment," which is accessing an mobile app, re-SET, for cognitive behavioral therapy extension that is to be used with MAT (Buprenorphine only at this time).
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Starting outpatient treatment for OUD within the PACMAT Hub and Spoke system (either the Hub or one of the Spokes)
- •Planning maintenance treatment with buprenorphine
- •Willing to participate in the study
- •Can read, write and comprehend English
Exclusion Criteria
- •Planning an outpatient detoxification, or treatment other than buprenorphine maintenance (e.g. methadone maintenance, Vivitrol, or counseling with no medication)
- •Judged by the evaluating physician or allied clinician to need a higher level of care (e.g. residential or inpatient treatment)
- •Unwilling to participate in the study
- •Under the age of 18
- •Unable to read, write and comprehend English
Outcomes
Primary Outcomes
Retention in treatment on MAT for 6 months after enrolling in the study
Time Frame: 6 months
ReSET is a mobile app designed to provide extended cognitive behavioral therapy for patients initiating medication assisted treatment (MAT) for opioid use disorder (OUD). This pilot trial is evaluating the acceptability and feasibility of the app, reSET. The first outcome being measure is treatment retention. We want to examine if participants enrolled in the study will maintain on MAT for 6 months after enrollment. This will be evaluated based on the number of appointments attended by the research participants. Data mining through our systems electronic medical record (EMR) will be conducted in order to count the number of attended appointments for study participants to gauge their treatment retention.
Secondary Outcomes
- Opioid and other substance abuse as assessed through biological specimen(6 months)
- Opioid and other substance abuse as assessed through participant self-report(6 months)
- Health status as assessed by the EuroQol(6 months)
- Overall mental health symptoms related to depression and anxiety as assessed by the K-10(6 months)
- HIV Risk as assessed by the SERBAS(6 months)
- Cravings to use drugs as assessed by the reSET app(6 months)
- Coping strategies as assessed by the CSS(6 months)
- Satisfaction of using reSET as a form of treatment as measured by a qualitative interview(6 months)
- Mental health symptoms specific to depression as assessed by the PHQ-9(6 months)
- Mental health symptoms related to PTSD as assessed by the PCL-C(6 months)
- Social Connectedness as assessed by the SCS(6 months)
- Effectiveness of the reSET app content as measured by the IAFF(6 months)
Investigators
Sarah Kawasaki
Assistant Professor
Milton S. Hershey Medical Center