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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Behavioral
Primary Purpose
Treatment
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness-Oriented Recovery Enhancement: (MORE) group
  • Behavioral: Mindfulness-Oriented Recovery Enhancement: (MORE) group
    Mindfulness-Oriented Recovery Enhancement (MORE) is a novel social work intervention and mental training program that unites complementary aspects of mindfulness training.
Placebo Comparator
Psychoeducation
  • Behavioral: Psychoeducation
    Education on the neurobiology of pain, healthy eating, diet, sleep and stress

Recruiting Locations

Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
Contact:
Marie Curiel
617-732-9578
MCURIEL@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.