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Chronic PainOPTIMUMNCT04129450

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

A study testing Group medical visits with mindfulness-based stress reduction and Usual PCP care in people with Chronic Pain and Back Pain, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain, Back Pain
What is being tested?
Group medical visits with mindfulness-based stress reduction and Usual PCP care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
451 participants
Where
1 siteUnited States
Study dates
6 May 2021to 6 Nov 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site
  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Group medical visits with mindfulness-based stress reduction, Usual PCP care
Keywords
Mindfulness-Based Stress Reduction, Medical group visits, Primary care setting
Medical subject headings
Chronic Pain, Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group medical visits with mindfulness-based stress reductionOther

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

  • Usual PCP careOther

    Usual one on one PCP care for chronic lower back pain

Study groups in NCT04129450
Study groupRoleWhat they receive
Mindfulness Pain Program + Usual PCP CareExperimentalParticipants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain.
Receives: Other: Group medical visits with mindfulness-based stress reduction; Other: Usual PCP care
Usual PCP CareActive comparatorParticipants will receive usual PCP care for chronic lower back pain.
Receives: Other: Usual PCP care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (12)
  1. Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months

    Physical function will be assessed using the 4 items Patient Reported Outcome Measurement Information System (PROMIS) at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back). For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 22.5 to 57. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 21 to 59. Higher scores are more favorable.

    Measured: Baseline, 8 weeks, 6 months, 12 months

  2. Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months

    Sleep disturbance will be assessed using the 4 items PROMIS at 8 weeks and 12 months and the 6 items PROMIS assessment at baseline and 6 months. It assesses self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. For the 4 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 4 to 20, and t-scores range from 32 to 73.3. For the 6 items PROMIS, each question usually has five response options ranging in value from one to five. Raw scores range from 6 to 30, t-scores range from 31.7 to 76.1. Higher scores indicate worsen sleep disturbance.

    Measured: Baseline, 8 weeks, 6 months, 12 months

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

    The Current Opioid Misuse Measure® (COMM) will be used to assess opioid prescription use. It is a 17-item, patient self-assessment measure designed to identify individuals taking opioids. Scoring is based on a Likert 5-point scale from 0 (never) to 4 (very often). A score of 9 or above is a positive indicator, ie, participant has been identified as misusing his/her medication and is at an increased risk of abuse.

    Measured: Baseline, 8 weeks, 6 months, 12 months

  4. Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months

    Mindfulness will be assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R). 12-item questionnaire with a total score range of 12 to 48 that measures everyday mindfulness, and focuses on the degree to which respondents experience their thoughts and feelings. Items are rated on a 4-point Likert scale from 1 (rarely/not at all) to 4 (almost always). Scores on the scale are summed. Higher scores reflect greater mindfulness.

    Measured: Baseline, 8 weeks, 6 months,12 months

  5. Mindfulness at 12 Months

    Mindfulness will be assessed by the Global Mindfulness Measure at 12 months. Items are rated on a 5-point Likert scale from 1 (rarely/not at all) to 5 (very much). Scores on the scale are summed and converted to a t-score, with a total t-score range of 23 to 75.7. The scale provides T-scores that standardize results to a mean of 50 and a standard deviation (SD) of 10, based on the U.S. general population. Higher scores reflect greater mindfulness.

    Measured: 12 months

  6. Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months

    Patient impression of change is assessed by the self-report measure Patient Global Impression of Change (PGIC) reflects a respondent's belief about the efficacy of treatment to their pain. This single-item scale is rated on a 6-point Likert scale from 0 (very much improved) to 6 (very much worse).

    Measured: 8 weeks, 6 months,12 months

  7. Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months

    Pain catastrophizing will be assessed by the Pain Catastrophizing Scale short form, a 6-item self-report questionnaire that assesses how catastrophic thinking about low back pain affects respondents. Respondents are asked to indicate the degree to which they have the above thoughts and feelings when they are experiencing pain using the 0 (not at all) to 4 (all the time) scale. A total score is ranged from 0-24, and the higher score indicates greater pain catastrophizing.

    Measured: Baseline, 8 weeks, 6 months, 12 months

  8. Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months

    The Tobacco, Alcohol, Prescription medications, and other Substance (TAPS-1) Tool consists of a 4-item screening for tobacco use, alcohol use, prescription medication misuse, and illicit substance use in the last 12 months. Each item is rated on a 5-point Likert scale from 0 (daily to almost daily) to 4 (never). If any item in the TAPS-1 has a response other than "Never" then score this item as positive screening.

    Measured: Baseline and 12 months

  9. Comorbidity at Baseline

    Comorbidity will be assessed by the Charlson Co-Morbidity Index (CCI) with 20 items about different health conditions. The CCI ranges from 0 to 37, with higher scores indicating a higher burden of comorbidity.

    Measured: Baseline

  10. Anxiety at Baseline, 6 Months, & 12 Months

    Anxiety will be assessed by the Generalized Anxiety Disorder 2-item (GAD-2), a brief screening tool for generalized anxiety disorder (GAD) and other common anxiety disorders, such as panic disorder, social anxiety disorder, and posttraumatic stress disorder. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The total GAD-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the GAD-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population.

    Measured: Baseline, 6 Months, 12 Months

  11. Depression at Baseline, 6 Months, & 12 Months

    Depression will be assessed by the Patient Health Questionnaire 2-item (PHQ-2), a brief screening tool for depression. Each item is ranged from 0 (not at all) to 3 (Nearly every day). The PHQ-2 score ranges from 0-6, and the cut-off point is 3. A score of ≥ 3 on the PHQ-2 has been identified as an acceptable cut-off for identifying clinically significant anxiety symptoms in the general population.

    Measured: Baseline, 6 Months, 12 Months

  12. Sleep Duration at Baseline and 6 Months

    Sleep duration will be assessed by a single-item survey asking the amount of actual sleep the respondent got at night per night in the last month in hours and minutes.

    Measured: Baseline, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2019
  2. Study start6 May 2021
  3. Primary completion6 Nov 2024
  4. Study completion6 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
451 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04129450
Sponsor's protocol ID
H-39165
Other IDs
4UH3AT010621-02
Acronym
OPTIMUM
Status last verified
Mar 2026
First submitted
14 Oct 2019
Last updated
8 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Foster MV, Nguyen PT, Weinberg J, Faurot KR, Morone N. The Impact of Telehealth Use Experience on Recruitment of Underserved Populations Into a Telehealth-Delivered Mindfulness-Based Trial for Patients With Chronic Low Back Pain: Cross-Sectional Survey. JMIR Mhealth Uhealth. 2026 Jul 29;14:e82093. doi: 10.2196/82093.

    PubMed 42525540
  • Morone NE, Faurot KR, Weinberg J, McTigue K, Roth I, Barnhill J, Gardiner P, Thomas HN, Lathren CR, Castro MG, Baez J, Lawrence S, Harr E, Elhadidy N, White AM, Nguyen PT, Dore G, Rodriguez R, Gaylord SA, Greco CM. Mindfulness-Based Group Medical Visits for Persons With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2026 Jun 29:e262186. doi: 10.1001/jamainternmed.2026.2186. Online ahead of print.

    PubMed 42371634
  • 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.

    PubMed 40891220
  • 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.

    PubMed 40162193
  • 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.

    PubMed 34455111

Questions about this trial

What is this clinical trial studying?

A study testing Group medical visits with mindfulness-based stress reduction and Usual PCP care in people with Chronic Pain and Back Pain, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity and Interference at Baseline, 8 Weeks, 6 Months (Primary Timepoint), & 12 Months: Pain, Enjoyment, General Activity (PEG) Score (time frame: Baseline, 8 weeks, 6 months (primary timepoint), 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04129450, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.

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