Single Arm Trial Identifying Barriers and Facilitators to Mindfulness Practice
Recruiting · NCT07573241 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Washington
View the official record on ClinicalTrials.gov →Interventions studied
MBCT
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- University of Washington - Seattle, Washington, United States