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

NCT04129450 | Completed Results

• 2 other identifiers: H-391654UH3AT010621-02
• Study Type: interventional
• Target: 451
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Pain; Back Pain

Keywords

Mindfulness-Based Stress Reduction; Medical group visits; Primary care setting

Outcome Measures

Primary Outcomes (1)

• Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score

  The PEG (pain, enjoyment, general activity) composite score will be used to assess pain intensity and interference. The PEG is a 3 item score with potential responses of 0 to 10 with 10 being the most severe pain. The 3 PEG items referring to the past week are: average pain, how pain interfered with enjoyment of life, how pain interfered with general activity To compute the PEG score, add the responses to the questions above, then divide by three to get a final score out of 10.

  Baseline, 8 weeks, 6 months (primary timepoint), 12 months

Secondary Outcomes (12)

• Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months

  Baseline, 8 weeks, 6 months, 12 months

• Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months

  Baseline, 8 weeks, 6 months, 12 months

• Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months

  Baseline, 8 weeks, 6 months, 12 months

• Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months

  Baseline, 8 weeks, 6 months,12 months

• Mindfulness at 12 Months

  12 months

Study Arms (2)

Mindfulness Pain Program + Usual PCP Care

EXPERIMENTAL

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.

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

Usual PCP Care

ACTIVE COMPARATOR

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

Other: Usual PCP care

Interventions

Group medical visits with mindfulness-based stress reduction OTHER

Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits

Mindfulness Pain Program + Usual PCP Care

Usual PCP care OTHER

Usual one on one PCP care for chronic lower back pain

Mindfulness Pain Program + Usual PCP Care; Usual PCP Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Pain, Enjoyment of Life and General Activity (PEG)
• Willing and able to provide online or telephone informed consent
• Speak English as the intervention manual is currently written in English

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• Miller VE, Barnhill J, Greco CM, Castro G, Nguyen TP, Gardiner P, Faurot KR, Gaylord S, Weinberg JM, Thomas HN, Sariahmed K, Morone NE. Prevalence of Chronic Overlapping Pain Conditions in Participants With Chronic Low Back Pain Enrolled in a Pragmatic Trial of Mindfulness-Based Stress Reduction. Eur J Pain. 2025 Oct;29(9):e70119. doi: 10.1002/ejp.70119.

  PMID: 40891220 DERIVED

• Barnhill JL, Castro G, Lathren C, Harr E, Roth I, Baez JE, Rodriguez R, Lawrence S, Gardiner P, Greco CM, Thomas HN, Gaylord SA, Dore G, Bengert A, Morone NE. The Hidden Complexity of Virtual Mindfulness-Based Group Medical Visits: Comfort, Challenge, and the Influence of Social Determinants of Health. Glob Adv Integr Med Health. 2025 Mar 27;14:27536130251326938. doi: 10.1177/27536130251326938. eCollection 2025 Jan-Dec.

  PMID: 40162193 DERIVED

• Greco CM, Gaylord SA, Faurot K, Weinberg JM, Gardiner P, Roth I, Barnhill JL, Thomas HN, Dhamne SC, Lathren C, Baez JE, Lawrence S, Neogi T, Lasser KE, Castro MG, White AM, Simmons SJ, Ferrao C, Binda DD, Elhadidy N, Eason KM, McTigue KM, Morone NE. The design and methods of the OPTIMUM study: A multisite pragmatic randomized clinical trial of a telehealth group mindfulness program for persons with chronic low back pain. Contemp Clin Trials. 2021 Oct;109:106545. doi: 10.1016/j.cct.2021.106545. Epub 2021 Aug 27.

  PMID: 34455111 DERIVED

MeSH Terms

Conditions

Chronic Pain; Back Pain

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Natalia Morone, MD, MS
• Organization: Boston Medical Center

natalia.morone@bmc.org

617-414-6652

Study Officials

• Natalia Morone, MD, MS

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2019
• First Posted: October 16, 2019
• Study Start: May 6, 2021
• Primary Completion: November 6, 2024
• Study Completion: November 6, 2024
• Last Updated: April 8, 2026
• Results First Posted: December 1, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)