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.
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.
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.
- Conditions
- Chronic Pain, Back Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Usual PCP care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted16 Oct 2019
- Study start6 May 2021
- Primary completion6 Nov 2024
- Study completion6 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Natalia Morone, MD, MS, Principal investigator, Boston Medical Center
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 42525540Morone 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 42371634Miller 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 40891220Barnhill 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 40162193Greco 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Mindfulness for Patients With Chronic Low Back Pain in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT04129450
- Acronym / sponsor ID
- OPTIMUM / H-39165
- Conditions
- Chronic Pain, Back Pain
- Keywords
- Mindfulness-Based Stress Reduction, Medical group visits, Primary care setting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 6 Nov 2024 (actual)
- First posted
- 16 Oct 2019 (actual)
- Results
- Posted 1 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Pain Program + Usual PCP Care | Experimental | Other: Group medical visits with mindfulness-based stress reduction, Other: Usual PCP careParticipants will undergo 8 weekly 90 minute sessions of Mindfulness-Based Stress Reduction in addition to receiving usual PCP care for chronic lower back pain. |
| Usual PCP Care | Active comparator | Other: Usual PCP careParticipants will receive usual PCP care for chronic lower back pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group medical visits with mindfulness-based stress reductionEight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits | Other | Mindfulness Pain Program + Usual PCP Care |
| Usual PCP careUsual one on one PCP care for chronic lower back pain | Other | Mindfulness Pain Program + Usual PCP Care, Usual PCP Care |
Primary outcome
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
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.
12 secondary outcomes
Physical Function at Baseline, 8 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 8 weeks, 6 months, 12 months
Sleep Disturbance at Baseline, 8 Weeks, 6 Months, & 12 Months
Time frame: Baseline, 8 weeks, 6 months, 12 months
Opioid Prescription Use at Baseline, 8 Weeks, 6 Months, and 12 Months
Time frame: Baseline, 8 weeks, 6 months, 12 months
Mindfulness at Baseline, 8 Weeks, 6 Months, & 12 Months
Time frame: Baseline, 8 weeks, 6 months,12 months
Mindfulness at 12 Months
Time frame: 12 months
Patient Impression of Change at 8 Weeks, 6 Months, & 12 Months
Time frame: 8 weeks, 6 months,12 months
Pain Catastrophizing at Baseline, 8 Weeks, 6 Months, & 12 Months
Time frame: Baseline, 8 weeks, 6 months, 12 months
Tobacco, Alcohol, Prescription Medications, and Other Substance Use at Baseline and 12 Months
Time frame: Baseline and 12 months
Comorbidity at Baseline
Time frame: Baseline
Anxiety at Baseline, 6 Months, & 12 Months
Time frame: Baseline, 6 Months, 12 Months
Depression at Baseline, 6 Months, & 12 Months
Time frame: Baseline, 6 Months, 12 Months
Sleep Duration at Baseline and 6 Months
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42525540Foster 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.
- Derived from this study: PubMed 42371634Morone 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.
- Derived from this study: PubMed 40891220Miller 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.
- Derived from this study: PubMed 40162193Barnhill 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.
- Derived from this study: PubMed 34455111Greco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Natalia Morone, MD, MS principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
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.