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

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.

• Depression assessed by the eight-item Patient Health Questionnaire for Depression (PHQ-8) [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Anxiety assessed by the Generalized Anxiety Disorder-7 (GAD-7) [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Pain Self-Efficacy assessed by the Pain Self-Efficacy Questionnaire [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Catastrophizing assessed by the Pain Catastrophizing Scale Short Form [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Quality of Life assessed by the Patient Reported Outcomes Measurement Information System (PROMIS 29) [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Participants' Impression of change [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Mindfulness assessed by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Sleep disturbance assessed by the PROMIS Sleep Disturbance-Short Form 6a [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Pain-Sleep Duration [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Treatment components and effects assessed by the Healing Encounters and Attitudes List-Expectation [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]
• Social support assessed by the Social Network Index [Срок оценки: baseline, 4 weeks, 8 weeks, 4 months, 6 months]