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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Back Pain; Chronic Pain
• Intervention / Treatment: Other: Group medical visits with mindfulness-based stress reduction; Other: Usual PCP care

Detailed Description

The research will be conducted with three health care system (HCS) sites: Boston Medical Center, MA, a safety net health system; UPMC, Pittsburgh, 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 Type: Interventional
• Enrollment (Actual): 451
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natalia Morone, MD, MS; Phone Number: 617-414-6652; Email: natalia.morone@bmc.org
• Study Contact Backup: Name: Jose Baez, MD; Phone Number: 617-414-6999; Email: jose.baez@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 PEG
• Willing and able to provide online or telephone informed consent
• Speak English as the intervention manual is currently written in English

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Active Comparator: Usual PCP Care; Participants will receive usual PCP care for chronic lower back pain.	Other: Usual PCP care; Usual one on one PCP care for chronic lower back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity and interference at Baseline, 8 weeks, 6 months (primary timepoint), & 12 months: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of healthcare resources by participants as documented in the EHR	The electronic health record (EHR) will be reviewed of each participants to ascertain the healthcare resources used.	12 months
Physical function at Baseline, 8 weeks, 6 months, and 12 months	Physical function will be assessed using the 4 items PROMIS (Patient Reported Outcome Measurement Information System) 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.	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.	Baseline, 8 weeks, 6 months, 12 months
Quality of Life at Baseline, 8 weeks, 6 months, & 12 months	Quality of life will be assessed using the PROMIS-29+2 Profile v2.1 (PROPr) at baseline, 8 weeks, 6 months, & 12 months. The PROPr assesses pain intensity using a single 0-10 numeric rating item and eight health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, sleep disturbance, and cognitive function abilities) using four items per domain. Raw scores range from 4 to 20 for each health domain and there are t-scores for each domain. Higher score in physical function, cognitive function, & ability to participate in social roles & activities) indicate good health, and high scores in other domain indicate worse health.	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.	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 scale 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.	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. Higher scores reflect greater mindfulness.	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).	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.	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 part 1 has a response other than "Never" then score this item as positive screening.	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. Respondents are divided into three groups based on their CCI scores: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5.	Baseline
Treatment expectation at baseline	Treatment expectation will be assessed by Treatment Expectancy scale (TEX-Q). The scale consists of 6 items, and each item is rated on a 5-point Likert scale from 1(Not at all) to 5 (Very much). Total raw score is ranged from 6 to 35, and t-score is ranged from 26.1 to 70.8. Higher score indicates higher expectation.	Baseline
Telehealth Usability at Baseline and 8 weeks	The Telehealth Usability Questionnaire short form (TUQ) will be use to assess respondent's experience with telehealth (interface quality, satisfaction, & future use). The scale consists of 7 item, and each item is rated on a 7-point Likert scale from 0 (Strongly Disagree) to 7 (Strongly Agree). The higher the overall average, the higher the usability of the telehealth system.	Baseline, 8 weeks
Anxiety at Baseline	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.	Baseline
Depression at Baseline	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.	Baseline
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.	Baseline, 6 months
Classes of back pain medication	This outcome will be assessed by the count of participants that take the following pain medication classes: Acetaminophen, NSAIDs (Aspirin, Ibuprofen, Motrin), Muscle Relaxants, Antidepressants, and Opioids	Baseline, 8 weeks, 6 months, 12 months
Amount of opioid pain medication	This outcome will be assessed by determining Morphine Milligram Equivalents (MME) for opioid medications.	Baseline, 8 weeks, 6 months, 12 months
Trauma at 8 weeks	Trauma will be assessed by the Life Events Checklist (LEC-5) is a self-report measure that assesses exposure to 17 potentially traumatic events in a respondent's lifetime. Respondents indicate varying levels of exposure to each type of potentially traumatic event included on a 6-point nominal scale, and respondents may endorse multiple levels of exposure to the same trauma type. The LEC-5 does not yield a total score or composite score.	8 weeks
Chronic overlapping pain at 8 weeks	Chronic overlapping pain will be assessed by the Chronic Overlapping Pain Conditions Screener (COPCs), an assessment tool that helps in the identification of different COPCs that may co-exist within a given individual. The screener consists of 10 COPC conditions and identifies the number of conditions co-occur within a given individual.	8 weeks
Dietary supplement and natural products use at 1 month	Dietary supplement and natural product use will be assessed by a 10-item questionnaire. The questionnaire identifies if the respondents may have used any dietary supplement and natural products for chronic low back pain management in the past 30 days.	Once at any timepoint

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Natalia Morone, MD, MS, Boston Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness-Based Stress Reduction; Medical group visits; Primary care setting
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Chronic Pain
• Other Study ID Numbers: H-39165; 4UH3AT010621-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No