Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: MBCT

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erin G Mistretta, PhD; Phone Number: 206-668-4168; Email: emistr@uw.edu
• Study Contact Backup: Name: Dawn Ehde, PhD; Phone Number: 206-744-2811; Email: edhe@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 6 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mindfulness-Based Cognitive Therapy (MBCT); Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 8-10 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.

Behavioral: MBCT; Participants will attend eight, 2-hour group treatment MBCT sessions delivered using free video-conferencing technology. Groups will consist of 8-10 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily Mindfulness Practice	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.	Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of Mindfulness Practice	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.	Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Quality of Mindfulness Practice	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.	Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity	Participant-rated pain severity assessed via the 3-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity scale at pre- and post-intervention.	Pre-intervention and post-intervention (approximately 10 weeks apart)
Pain Interference	The degree to which pain limits a participant's daily activities and functioning, assessed via the 6-item Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference scale at pre- and post-intervention.	Pre-intervention and post-intervention (approximately 10 weeks apart)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Erin Mistretta, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: May 1, 2026
• First Submitted That Met QC Criteria: May 1, 2026
• First Posted (Actual): May 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis
• Other Study ID Numbers: STUDY00023785; 1K23AT013270-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Upon publication, researchers may request a de-identified dataset containing all variables used in the published article. Requestors will receive the published article, a variable list with labels, and the dataset as an SPSS (.sav) file. Although data files will be stripped of identifiers prior to sharing, there remains a small risk that individuals with unusual combinations of characteristics could potentially be re-identified through deduction. To minimize this risk, the investigators will review each dataset prior to sharing and remove or collapse any variables that could increase re-identification risk.
• IPD Sharing Time Frame: The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
• IPD Sharing Access Criteria: The investigators will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No