Randomized Trial of ACT and a Care Management App in Primary Care-based Buprenorphine Treatment
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Hector Perez, MD · PRINCIPAL_INVESTIGATOR · Albert Einstein College of Medicine Montefiore Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Change in Pain InterferenceBaseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Change in Pain Interference on average over the prior 7-day period will be assessed using the Brief Pain Inventory (BPI) pain interference subscale. The BPI pain interference subscale consists of 7 items which asks patients to rate how much pain has interfered with mood, walking ability, work, relations with others, sleep, enjoyment of life, and general activity using a 0-10 numeric rating scale (NRS), where 0 represents "Does not interfere" and 10 represents "Completely interferes" such that higher scores are associate with greater pain interference. Scores from the seven items are averaged to obtain a mean score. Higher scores are indicative of more interference with daily life. Results will be summarized by study arm using basic descriptive statistics.
- Illicit Opioid UseBaseline, 6 weeks, 12 weeks, 24 weeks, and 36 weeks
Illicit opioid use will be a composite outcome defined by self-reported opioid use days over the past 30 days using items from a modified Addiction Severity Index questionnaire. It is defined by the maximum number of days of use of: a) heroin, b) fentanyl \[unprescribed\], and c) prescription opioids or analgesics \[unprescribed\]. The possible range of days is 0-30. Results will be summarized by study arm using basic descriptive statistics.