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

Boston Medical Center (BMC)

Status: Completed

Conditions: Back Pain; Chronic Pain

Treatments: Other: Group medical visits with mindfulness-based stress reduction; Other: Usual PCP care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04129450

H-39165

4UH3AT010621-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 451 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• Chronic low back pain, which is pain that persists for at least 3-months and has resulted in pain on at least half the days in the past 6 months
• A score ≥ 3 on the PEG
• Willing and able to provide online or telephone informed consent
• Speak English as the intervention manual is currently written in English

Exclusion criteria

• Do not meet the above 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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451 participants in 2 patient groups

Mindfulness Pain Program + Usual PCP Care

Experimental group

Description:

Participants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain.

Treatment:

Other: Usual PCP care

Other: Group medical visits with mindfulness-based stress reduction

Usual PCP Care

Active Comparator group

Description:

Participants will receive usual PCP care for chronic lower back pain.

Treatment:

Other: Usual PCP care