Adjunctive Mindfulness During Opioid Tapering for Patients With Chronic Pain
Overview
- Phase
- Not Applicable
- Intervention
- Mindfulness-Oriented Recovery Enhancement: (MORE) group
- Conditions
- Low Back Pain
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Pain Interference
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
This study is a Randomized Controlled Trial exploring the effects of a Mindfulness interventions in reducing pain interference and opioid dose in patients with Chronic Low Back Pain. A total of 200 opioid-using patients with chronic pain, male and female participants will be enrolled, with a need for 160 completers. Patient will be randomly assigned into the Mindfulness-Oriented Recovery Enhancement or the Psychoeducation comparison control group.
Investigators
Asimina Lazaridou, PhD
Instructor
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •age\>18yo
- •Chronic Low Back Pain as seen on medical history as well as score of \>3 on pain visual analog scale (VAS) at the start of experimental sessions.
- •receiving prescription opioids for three or more months and planning to start tapering their opioids with their provider.
- •willing to be randomized to one of the two behavioral treatment. Patients referred or self-referred to the study from an outside clinic will also be able to participate (we will be in contact with their prescribing provider)
- •able and willing to perform/tolerate pain procedures (e.g., QST)
- •able to communicate fluently in English
- •able to use a smartphone or laptop for the virtual therapy program
Exclusion Criteria
- •Current illicit substance use (e.g marijuana use will be exempted) at screening or during trial as verified by urine toxicology screen and/or self-report for all participants;
- •Medical condition known to influence QST or participation in the MORE intervention; serious psychiatric condition;
- •regular meditation practice
- •cognitive impairment
- •pregnancy
- •lack of English fluency
- •severe OUD
- •inability to provide informed consent.
Arms & Interventions
Mindfulness-Oriented Recovery Enhancement: (MORE) group
Intervention: Mindfulness-Oriented Recovery Enhancement: (MORE) group
Psychoeducation
Intervention: Psychoeducation
Outcomes
Primary Outcomes
Pain Interference
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed by the Brief pain interventory
Opioid Dose
Time Frame: Baseline, 8 weeks, 3 month and 6 month follow up
assessed through their medical record
Secondary Outcomes
- Opioid Misuse(Baseline, 8 weeks, 3 month and 6 month follow up)
- Opioid Craving(Baseline,8 weeks, 3 month and 6 month follow up)
- Opioid Withdrawal(Baseline, 8 weeks, 3 month and 6 month follow up)
- Pain Intensity(Baseline, 8 weeks, 3 month and 6 month follow up)