Group-based Mindfulness for Chronic Pain in the Primary Care Setting
NCT ID: NCT04129450
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
451 participants
INTERVENTIONAL
2021-05-06
2024-11-06
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mindfulness Pain Program + Usual PCP Care
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.
Group medical visits with mindfulness-based stress reduction
Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
Usual PCP care
Usual one on one PCP care for chronic lower back pain
Usual PCP Care
Participants will receive usual PCP care for chronic lower back pain.
Usual PCP care
Usual one on one PCP care for chronic lower back pain
Interventions
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Group medical visits with mindfulness-based stress reduction
Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
Usual PCP care
Usual one on one PCP care for chronic lower back pain
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Natalia Morone, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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H-39165
Identifier Type: -
Identifier Source: org_study_id