Identifying what helps or hinders mindfulness practice for people with multiple sclerosis and chronic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm study embedded in a larger project to create a phone-based just-in-time support tool for mindfulness in people with MS and chronic pain. Eight weeks of group-based MBCT will be delivered via telehealth to 80 participants, while real-time self-reports are collected twice daily through a smartphone app to identify barriers and facilitators to home practice. Data will inform development of a JITAI to improve adherence and potential benefits of mindfulness practice. The study uses ecological momentary assessment to capture fluctuations in mood, fatigue, pain, and environment in daily life. This initial aim focuses on understanding practice patterns, rather than directly measuring clinical outcomes of MBCT in this protocol.

Why it matters

Who can join: the full rules

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 it's running

• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Erin Mistretta, PhD — University of Washington
• Study coordinator: Erin G Mistretta, PhD
• Email: emistr@uw.edu
• Phone: 206-668-4168

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.