Reward-Based Recovery Outcomes Management for Opioid Use Disorder
- Conditions
- Opioid Use Disorder
- Interventions
- Behavioral: PROCare
- Registration Number
- NCT04669249
- Lead Sponsor
- Medical Decision Logic, Inc.
- Brief Summary
A randomized pilot study assessing feasibility, acceptability, and preliminary effectiveness of a reward-based recovery management platform (PROCare) designed to enhance participation in outcomes monitoring, engagement in treatment care, and adherence to medication for opioid use disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
- 18 years of age or older
- access to internet-enabled smartphone device
- primary DSM-5 opioid use disorder diagnosis
- receiving medication treatment for opioid use disorder with buprenorphine
- English language proficient
- active suicidal ideation or psychotic symptoms
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PROCare PROCare Technology-enabled, reward-based recovery platform
- Primary Outcome Measures
Name Time Method Percentage of Participants Completing Outcomes Monitoring Surveys 4-week Assessed by % of participants completing assessment surveys during study period with higher values indicating greater survey participation.
Percentage of Participants Fully-Adherent to Care Plan 4-week Assessed by % of participants fully-adherent to weekly outpatient individual therapy visits, community-based mutual-help recovery support meetings, and other scheduled appointments attended during study period with higher values indicating greater care plan adherence.
Percentage of Participants Fully-Adherent to Buprenorphine 4-week Assessed by % of participants fully-adherent to daily doses during study period with higher values indicating greater buprenorphine adherence.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Using Opioids 4-week Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period.
Change in Quality of Life as Assessed by EUROHIS-QOL 8-item Index From Baseline to 4-Week Follow-up 4-week The EUROHIS-QOL (European Health Interview Survey-Quality of Life) 8-item index is an efficient, valid, and reliable measure of four quality of life domains (physical, psychological, environmental, and social). Items are rated on a 5-point Likert-type scale and summed to produce a total quality of life score (Range: 8-40) with higher scores indicating a higher level of satisfaction with their current quality of life. Change in scores from baseline to 4-week follow-up was examined with a higher change score indicating a greater increase in participant quality of life.
Change in Opioid Craving as Assessed by Opioid Craving Scale (OCS) From Baseline to 4-Week Follow-up 4-week OCS is a 3-item measure of opioid craving with acceptable internal consistency, reliability, and concurrent/predictive validity. Participants rate their level of craving in reference to three situations (current, past week, and high-risk environment) on a scale ranging from 0-10 to produce a total score ranging from 0-30 with higher scores indicating greater reduction in craving. Change in OCS scores from baseline to 4-week follow-up was examined to determine reductions in craving.
Percentage of Participants Using Other Substances (Non-opioids) 4-week Assessed by participant self-report and positive urine drug screens completed at routine clinic visits during study period for non-opioids substances (alcohol, cannabis, methamphetamine, amphetamines, cocaine, benzodiazepines).
Motivation as Assessed by Readiness Ruler 4-week Readiness Ruler is a valid and reliable 2-item measure of motivation and readiness to change. Participants rate their perceived "Importance" of making a change to their drug use behaviors, and their perceived "Confidence" in their ability to successfully achieve their goal (range: 0-100) with higher scores indicating greater motivation. Perceived "Importance" and "Confidence" scores are averaged to indicate a total Motivation score at 4-week follow-up (Range: 0-100).
Change in Opioid Use Disorder Impairment From Baseline to 4-Week Follow-up 4-week Participant self-report will be used to determine frequency counts of the 11 opioid use disorder diagnostic criteria per Diagnostic \& Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with higher counts indicating a greater number of symptoms/opioid-related impairment present and higher opioid use disorder severity. Total score indicating the total number of positive diagnostic criteria ranges from 0-11. Change in the number of diagnostic criteria endorsed from baseline to 4-week follow-up was examined to determine reduction in opioid-related impairment with higher scores indicating a greater reduction in symptoms over time.
Change in Self-Efficacy as Assessed by Brief Situational Confidence Questionnaire (BSCQ) From Baseline to 4-Week Follow-up 4-week BSCQ is an 8-item measure of self-efficacy for resisting the urge to use drugs in 8 high-risk situations based on the relapse prevention model (unpleasant emotions, physical discomfort, pleasant emotions, testing control, urges/temptations, interpersonal conflict, social pressure, and pleasant times with others). Patients rate their confidence in resisting the urge to use drugs in each of the 8 situations on a scale ranging from 0 (Not at all Confident) to 100 (Extremely Confident). Scores for each of the 8 situations are averaged to produce a total self-efficacy score (Range: 0-100). Change in scores from baseline to 4-week follow-up was examined with higher scores indicating a greater increase in self-efficacy.
Trial Locations
- Locations (1)
South Florida Behavioral Health Network, Inc.
🇺🇸Miami, Florida, United States