Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment

Study Overview
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Brief Summary
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This study will identify unique signatures that people have which can cause pain by evaluating biological, psychological, and social markers using artificial intelligence. These markers can be used to accurately predict the response of diverse individuals with chronic low back pain (cLBP) to Mindfulness-Based Stress Reduction. This will help enhance clinician decision-making and the targeted treatment of chronic pain. The overall objective is to use a unique machine learning (ML) approach to determine the biomarker signature of persons undergoing mindfulness based stress reduction (MBSR) treatment for their chronic low back pain (cLBP). This signature will facilitate clinical prediction and monitoring of patient response to MBSR treatment. The design of the study is a single-arm clinical trial of the evidence-based MBSR program for patients with cLBP.

Detailed Description
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UG3 Phase Overview. The first 24-months of the project will be dedicated to performing machine learning modeling to identify candidate predictive and monitoring markers of cLBP response to MBSR, prior to the full clinical trial in the UH3 phase. We will also refine our procedures such as recruitment and outcomes assessment with 50 persons during the UG3 phase. UH3 Phase Overview. Biopsychosocial markers will be identified of the response of diverse cLBP patients to MBSR (N=300) from comprehensive pain assessment and biopsychosocial data, including pain intensity and pain interference, physical activity, sleep, and heart rate for a 6-month period. Data will be collected and used for training and testing ML models. The MBSR program is evidence-based and meets weekly in a group via Zoom for 8-weeks for 90 minutes per week. Measures to determine biomarkers will be obtained at baseline (T1), four-weeks (T2), program completion (T3), four months (T4), and six months (T5). The main outcome timepoint with be at six months (T5), which allows time for durability of effects to be determined. The PEG (Pain, Enjoyment, General activity), obtained through online self-report surveys is the main outcome measure. Secondary outcomes of physical and psychological function will be self-report and obtained online, or if the patient prefers, by telephone, and physical activity, sleep, and heart rate variability will be collected by Fitbit.

Official Title
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Integrative Mindfulness-Based Predictive Approach for Chronic Low Back Pain Treatment

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Mindfulness meditation
* Other: Perspectives on pain
* Other: Discussion


Participation Criteria
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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 Willing and able to provide online or telephone informed consent Speak English as the intervention manual is currently written in English Exclusion Criteria: Red flags- recent (past month) worsening of pain, unexplained fever, unexplained weight loss Pregnancy Metastatic cancer Not a patient at a participating clinic or persons not planning to continue as a patient at a participating clinic for 6 or more months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness based stress reduction (MBSR) program<br>Participants will be enrolled in a 8-week mindfulness clinical pain program + Primary Care Provider (PCP) Usual Care. | Behavioral: Mindfulness meditation<br>* Ordinary activities like breathing, eating, and walking are turned into a meditation by creating greater awareness of the moment-to-moment sensations, emotions, thoughts and behaviors that arise during these activities.<br>Other: Perspectives on pain<br>* Understanding pain from a mind-body perspective and viewing pain as a stressor on physical sensations, thoughts, emotions, and behavior.<br>Other: Discussion<br>* Discussion on patients' use of mindfulness to work with pain and pain-themed meditations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, Enjoyment, General activity (PEG) composite score | The PEG is a 3-question scale: pain average, interference with general activity and interference with enjoyment of life. Each question is on a 0-10 scale, and total PEG is the average. Scores can range from 0-30 and <12=Mild,12 to <21 = Moderate, 21 to 30 = Severe chronic pain. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8) | The total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12). Total score ≥3 for first 2 questions suggests anxiety. Total score ≥3 for last 2 questions suggests depression. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7) | This is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of not at all, several days, more than half the days, and nearly every day. GAD-7 total score for the seven items ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire | The PSEQ is a 10-question survey that measures the confidence of a person with persistent pain to do a range of activities while in pain. The total score ranges from 0 to 60. High PSEQ scores are strongly associated with clinically- significant functional levels and provide a useful gauge for evaluating outcomes in chronic pain patients. Higher scores (and a higher percentile) represent higher confidence to function with pain. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Catastrophizing assessed by the Pain Catastrophizing Scale Short Form | The Pain Catastrophizing Scale (PCS) measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. It consists of 13 items scored from 0 to 4, with a total range of 0 to 52. Higher scores are less favorable and a score of more than 30 points may indicate clinical relevance. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29) | The PROMIS-29 v2. 0 profile measure assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items for each domain. HIgher scores indicate greater pain intensity. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Participants' Impression of change | Patient Global Impression of Change (PGIC) will be used to assess this outcome. A score of 1=No change (or condition has got worse), 2 = Almost the same, hardly any change at all, 3 = A little better, but no noticeable change, 4 = Somewhat better, but the change has not made any real difference, 5 = Moderately better, and a slight but noticeable change, 6 = Better, and a definite improvement that has made a real and worthwhile difference 7 = A great deal better, and a considerable improvement that has made all the difference. A 2-point change is significant from the last reported score | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) | The CAMS-R is a 12-item measure designed to capture a broad conceptualization of mindfulness with language that is not specific to any particular type of meditation training. Items 2, 6, and 7 are reverse-scored. After appropriate reversals, values for items 1 - 12 are summed. Higher values reflect greater mindful qualities. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a | The PROMIS 6a scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. The first two scale items assess sleep quality and the following 4 items assess domains of restfulness, sleep problems, and difficulty falling asleep. Each question has five response options ranging in value from one to five. To find the total raw score for a short so the range of scores is 6 to 30. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Pain-Sleep Duration | One question assesses sleep duration. This survey measures the impact of pain on the quality of sleep | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation | Six questions ask about treatment expectancy. It assesses participants' attitudes towards and perceptions of treatment components that associated with nont specific treatment effects | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 
| Social support assessed by the Social Network Index | 12 questions that ask about social support in regards to how many people a person sees and talk to regularly. The total score is calculated by finding the sum of the all items with a higher score indicating more social engagement. | baseline, 4 weeks, 8 weeks, 4 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness based stress reduction (MBSR), Machine learning (ML), Biopsychosocial data, PEG (Pain, Enjoyment, General activity), Pain interference, Pain intensity, Depression