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

NCT04129450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2026-04-08

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    collaborator NIH

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Natalia Morone, MD, MS · Boston Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-06
Primary Completion
2024-11-06
Completion
2024-11-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04129450 on ClinicalTrials.gov