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Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 week
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The primary outcome is whether a participant practiced mindfulness between each EMA survey."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at what makes daily mindfulness practice easier or harder for people with multiple sclerosis (MS) and ongoing pain. Mindfulness means paying attention to the present moment. People in the study take part in a group program called Mindfulness-Based Cognitive Therapy (MBCT).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have any type of MS confirmed by your medical records.
  • Have average pain above 3 on a 0–10 scale over the past week.
  • Have pain on more than half of the days in the past 3 months.
  • Can follow study steps and answer questions on your own using a mobile phone.

Who can't join

  • Are under 18, or cannot read or speak English.
  • Score above 8 on the Expanded Disability Status Scale, which measures disability from MS.
  • Make 1 or more errors on a 6-question test of memory and thinking.
  • Changed medicines that affect the course of MS in the past 3 months. You may qualify after 3 months.
  • Had an MS relapse (a flare-up of symptoms) within 30 days before screening. The listing says you may qualify after a 3-month waiting period.
  • Have current thoughts of suicide with a plan or intent to act, based on screening and further assessment. Thoughts without a plan or intent do not rule you out.
  • Are currently getting talk therapy for pain.
  • Currently practice mindfulness more than 3 days a week.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

WA