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Purpose

The goal of this pilot study is to examine the feasibility, acceptability, and preliminary effects of mindfulness-based stress reduction (MBSR) on interoception (your understanding of your body's internal senses), emotional well-being, and whole person health. A total of 30 people with chronic stroke will be enrolled in this study to participate in an MBSR course, consisting of a 30-minute intake visit, 8 sessions lasting 2.5 hours plus a 1-day 7-hour retreat. Participants will be randomized into either the first MBSR course (immediate start) or the second MBSR course (delayed start/waitlist control).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ability to consent to study participation - Age 18+ - Diagnosis of stroke ≥6 months prior to enrollment - A score of 5 or more on the Kessler Psychological Distress Scale (K6) - Reliable and consistent internet access and a device with video conferencing (e.g. Zoom) capabilities (e.g., smart phone, tablet, or laptop/computer) for the duration of the study - Able to attend an 8-week mindfulness course on Friday afternoons, starting approximately in mid-May or mid-July

Exclusion Criteria

  • Non-English speaking - Prior completion of an MBSR course - Active participation or past participation ≤3 months in any other interventional research study - History of any serious/uncontrolled neurological, psychiatric, or substance use disorder that would impact study participation - Any other clinically relevant finding that would pose a safety risk to the subject as determined by the investigator

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This study uses a waitlist control design where an immediate start arm receives the intervention immediately, and a delayed start arm receives the intervention approximately 8 weeks later.
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Immediate Start 		Individuals in the immediate start arm will receive the intervention (MBSR course) immediately upon enrolling, followed by an 8-week post intervention follow-up period.
  • Behavioral: Mindfulness-Based Stress Reduction (MBSR)
    MBSR consists of teaching meditation practices through breath and body awarness, awareness of movement through Yoga postures, and psychoeducation on stress reduction. The course will be offered online through video conferencing and will consist of a 30-minute intake visit, 8 weekly 2.5-hour sessions, and a 7-hour retreat.
Other
Delayed Start (Waitlist Control) 		Individuals in the delayed start arm will be waitlisted for approximately 8 weeks upon enrolling, followed by the MBSR course for an additional 8 weeks after the delay.
  • Behavioral: Mindfulness-Based Stress Reduction (MBSR)
    MBSR consists of teaching meditation practices through breath and body awarness, awareness of movement through Yoga postures, and psychoeducation on stress reduction. The course will be offered online through video conferencing and will consist of a 30-minute intake visit, 8 weekly 2.5-hour sessions, and a 7-hour retreat.

Recruiting Locations

HealthPartners Neuroscience Center
Saint Paul, Minnesota 55130
Contact:
Meghan O'Brien, MPH
651-493-6363
Meghan.E.Obrien@HealthPartners.com

More Details

Status
Recruiting
Sponsor
HealthPartners Institute

Study Contact

Meghan O'Brien, MPH
651-495-6363
Meghan.E.Obrien@HealthPartners.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.