Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice

Chronic pain affects about half of people with multiple sclerosis (PwMS), and standard drug treatments often provide limited relief. Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week program that combines mindfulness practices with cognitive and behavioral coping skills and has shown positive effects on pain severity, pain interference, and pain catastrophizing in PwMS. However, daily home practice is essential to achieving these benefits, and adherence is poor. People with chronic pain complete less than 40 out of every 100 recommended practice sessions. PwMS face unique barriers to practice including pain, fatigue, cognitive difficulties, and mood changes that can fluctuate within a single day. Understanding what drives or interferes with daily practice in this population is critical to improving MBCT outcomes.

This single-arm trial is the first aim of a research project designed to develop and optimize a smartphone-based just-in-time adaptive intervention (JITAI) to support mindfulness practice in PwMS during MBCT for chronic pain (1K23AT013270-01A1, Mistretta, PI). In this aim, 80 PwMS will participate in an 8-week group-based MBCT program delivered via telehealth. Ecological momentary assessment (EMA), a method of collecting real-time self-report data via smartphone, will be used to capture emotional, physical, and environmental factors as they naturally occur in daily life. Participants will complete twice-daily EMA surveys using an EMA smartphone app for 1 week before the program, during the 8-week program, and for 1 week after the program ends. Patient-reported outcome measures will be collected before and after the program.

The primary outcome is whether a participant practiced mindfulness between each EMA survey. Secondary outcomes include minutes practiced, type of practice (formal or informal), and self-rated quality of practice. Time-varying predictors assessed via EMA include positive and negative affect, stress, pain severity, pain interference, fatigue, sleep, location, social context, and time of day. Time-invariant predictors assessed at baseline include pain severity, pain interference, fatigue, pain catastrophizing, dispositional mindfulness, sleep, self-efficacy, depression, and cognitive functioning.

Multilevel modeling will be used to account for the nested data structure (assessments within days, within participants). A two-part modeling approach will assess both whether practice occurred on a given day and, on days when practice did occur, how much practice was completed. Three sets of models will examine same-day, longitudinal, and lagged relationships between predictors and practice outcomes. Predictors demonstrating at least a medium within-person effect on mindfulness practice will be considered as tailoring variables for the JITAI developed in the next phase of this project.

• Type of Mindfulness Practice [Срок оценки: Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)]
• Quality of Mindfulness Practice [Срок оценки: Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)]