Group-based Mindfulness for Chronic Pain in the Primary Care Setting (OPTIMUM)

  • STATUS
    Recruiting
  • End date
    Aug 12, 2024
  • participants needed
    450
  • sponsor
    Boston Medical Center
Updated on 4 October 2022
cancer
chronic pain
back pain
low back pain

Summary

The purpose of this pragmatic clinical trial (PCT) research is to determine whether a group-visit approach modeled on Mindfulness-Based Stress Reduction can improve function for persons with chronic low back pain. This will be done by an embedded PCT within the evidence-based "OPTIMUM" (Optimizing Pain Treatment In Medical settings Using Mindfulness) program.

Description

The research will be conducted with three health care system (HCS) sites: Boston Medical Center, MA, a safety net health system; UPMC, Pittsburgh, PA, a large health system; and Piedmont Health Services, NC, a network of federally funded health centers in partnership with the University of North Carolina (UNC), Chapel Hill.

As per NIH protocol for the funding, the first 12 month (Phase 1) of this PCT will be a pilot to plan and test the group-based mindfulness program for chronic pain program in each of the three sites with 5 participants/site. Once completed the Phase 2 will be conducted to integrate and test the group-based mindfulness program compared to standard of care for patients with chronic low back pain (cLBP) in the primary care setting at each collaborating site.

Eligible consenting participants will be randomized to either: the primary care providers (PCP) usual care group, or the group with both PCP usual care and the 8 weeks mindfulness clinical pain group. Participants will be asked to complete baseline and follow-up surveys about pain, function, pain medicine use, mood and anxiety symptoms, and quality of life. The surveys will take up to an hour to complete.

Details
Condition Chronic Pain, Back Pain
Treatment Group medical visits with mindfulness-based stress reduction, Usual PCP care
Clinical Study IdentifierNCT04129450
SponsorBoston Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss
Pregnancy
Metastatic cancer
First-degree relatives (parents, siblings, child) of someone who has participated or is participating in the OPTIMUM study
Members of the same household
Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 12 or more months
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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