NCT07573241 · University of Washington
Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
MBCT
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.
Primary outcome measures
Daily Mindfulness Practice
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Seattle, Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations