Multiple Sclerosis
Conditions
Brief summary
This observational study will examine what emotional, physical, and environmental factors make it easier or harder for people with multiple sclerosis (MS) and chronic pain to practice mindfulness daily while participating in a group-based Mindfulness-Based Cognitive Therapy (MBCT) program.
Detailed description
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.
Interventions
BEHAVIORALMBCT
Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 6-12 people who also have MS and chronic pain. Participants will be asked to practice skills learned in session between sessions. MBCT integrates mindfulness meditation practices within a CBT-oriented framework to address not only unhelpful pain cognitions and behaviors but also attentional control, decoupling of attention from emotion, mindful cognitions, and meditative behavior.
Sponsors
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have an MS diagnosis of any subtype per record review * Average pain intensity in past week of at least moderate severity (\>3 on the 0-10 numerical rating scale) * Report pain \>50% of days in the past 3 months. * Are able to comply with study procedures and complete measures independently via self-report (on mobile phone)
Exclusion criteria
* Less than 18 years of age * Score greater than 8 on the Expanded Disability Status Scale * Have significant cognitive impairment as indicated by 1 or more errors on the 6-item Cognitive Screener * Change in disease modifying medications in the past 3 months assessed via self-report (although participants will be considered eligible after the 3-month window) * History of MS relapse within the last 30 days prior to screening assessed via self-report (although participants will be considered eligible after the 3-month window) * Current suicidal ideation with intent or plan as indicated by a score of 1 or higher on the Patient Health Questionnaire-9 suicide item and further assessment with the Columbia-Suicide Severity Rating Scale (although individuals with suicidal ideation but no intent or plan will be considered eligible) * Currently engaged in psychotherapy for pain assessed via self-report * Currently have a "regular" mindfulness practice defined as \> 3 days per week assessed via self-report * Inability to read or speak English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Mindfulness Practice | Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program) | Whether a participant engaged in any formal (for example, sitting meditation) or informal (for example, mindfully engaging in a daily task) mindfulness practice since the last check-in, assessed via a single yes or now question delivered twice daily through the smartphone app. This will also be tracked passively by indicating whether participants accessed a guided meditation in the app itself. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type of Mindfulness Practice | Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program) | Whether the mindfulness practice completed since the last check-in was formal (for example, sitting meditation using a guided audio recording) or informal (for example, mindfully engaging in a daily task), assessed via a single multiple choice question delivered twice daily through the smartphone app. |
| Quality of Mindfulness Practice | Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program) | A participant's self-rated quality of their most recent mindfulness practice since the last check-in, assessed via the 1-item Practice Quality-Mindfulness (PQM) scale delivered twice daily through the smartphone app. A higher score indicates higher self-report practice quality. |
Countries
United States
Contacts
CONTACTErin G Mistretta, PhD
CONTACTDawn Ehde, PhD
PRINCIPAL_INVESTIGATORErin Mistretta, PhD
University of Washington
Outcome results
None listed