NCT04129450

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

Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The research will be conducted with three health care system (HCS) sites: Boston Medical Center (BMC), Massachusetts (MA), a safety net health system; University of Pittsburgh Medical Center (UPMC), Pittsburgh, Pennsylvania (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.

Conditions

• Chronic Pain
• Back Pain

Interventions

Type	Name	Description
OTHER	Group medical visits with mindfulness-based stress reduction	Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
OTHER	Usual PCP care	Usual one on one PCP care for chronic lower back pain

Timeline

• Start date: 2021-05-06
• Primary completion: 2024-11-06
• Completion: 2024-11-06
• First posted: 2019-10-16
• Last updated: 2026-04-08
• Results posted: 2025-12-01

Locations

1 site across 1 country: United States