Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice
2 other identifiers
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Jul 2026
Typical duration for not_applicable multiple-sclerosis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2026
CompletedFirst Posted
Study publicly available on registry
May 7, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
May 7, 2026
May 1, 2026
1.5 years
May 1, 2026
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Type of Mindfulness Practice
Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Quality of Mindfulness Practice
Twice daily for approximately 10 weeks (1 week before, 8 weeks during, and 1 week after the MBCT program)
Other Outcomes (2)
Pain Intensity
Pre-intervention and post-intervention (approximately 10 weeks apart)
Pain Interference
Pre-intervention and post-intervention (approximately 10 weeks apart)
Study Arms (1)
Mindfulness-Based Cognitive Therapy (MBCT)
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erin Mistretta, PhD
University of Washington
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor: Department of Rehabilitation Medicine
Study Record Dates
First Submitted
May 1, 2026
First Posted
May 7, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
May 7, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.