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

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.

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

Population: Persons with chronic low back pain 18 years old or older.

This outcome will be assessed by determining Morphine Milligram Equivalents (MME) for opioid medications.

Time frame: Baseline, 8 weeks, 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.

Time frame: Baseline

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.

Time frame: 8 weeks

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

Time frame: Baseline, 8 weeks, 6 months, 12 months

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.

Time frame: 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.

Time frame: Baseline

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.

Time frame: Once at any timepoint

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.

Time frame: 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.

Time frame: Baseline, 8 weeks, 6 months,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.

Time frame: 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.

Time frame: Baseline, 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).

Time frame: 8 weeks, 6 months,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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline, 8 weeks, 6 months, 12 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.

Time frame: Baseline, 6 months

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.

Time frame: Baseline, 8 weeks

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.

Time frame: Baseline and 12 months

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.

Time frame: 8 weeks

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.

Time frame: Baseline

The electronic health record (EHR) will be reviewed of each participants to ascertain the healthcare resources used.

Time frame: 12 months