Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

NCT07491861 | Recruiting

• 1 other identifier: A26-010
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Stroke Patients

Keywords

Mindfulness; MBSR; Chronic Stroke; Interoception

Outcome Measures

Primary Outcomes (4)

• Assessment of MBSR Intervention Feasibility by measuring class attendance

  Feasibility of the MBSR intervention will be assessed by measuring attendance of the sessions

  From pre-intervention visit to the end of treatment (~8 weeks)

• Assessment of MBSR Intervention Feasibility through item 4 of the CSQ-8

  Satisfaction with the course will be measured using item 4 of the CSQ-8, which asks whether the participant would recommend the course to others.

  From pre-intervention visit to end of treatment (~8 weeks)

• Assessment of Study Feasibility through measurement of participant recruitment

  Recruitment feasibility will be assessed by measuring the number of participants recruited within the 3-month recruitment window compared to the recruitment goals of the study.

  3-month recruitment period

• Assessment of Study Feasibility through measurement of participant study completion (retention)

  Retention will be measured by assessing number of recruited participants who complete all study visits.

  From enrollment to end of study (approximately 16 weeks)

Secondary Outcomes (8)

• Improvement of Interoception as assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA)

  From pre-intervention visit to end of treatment (~8 weeks)

• Assessment of Interoception using the Body Perception Questionnaire short form (BPQ-SF)

  From pre-intervention visit to end of treatment (~8 weeks)

• Assessment of Emotional Wellbeing through the Personal Health Questionnaire 8-item (PHQ-8)

  From pre-intervention visit to the end of treatment (~8 weeks)

• Assessment of Emotional Wellbeing using the Generalized Anxiety Disorder 7-item (GAD-7)

  From pre-intervention visit to the end of treatment (~8 weeks)

• Assessment of Emotional Well-being using the World Health Organization Wellbeing Index (WHO-5)

  From pre-intervention visit to the end of treatment (~8 weeks)

Study Arms (2)

Immediate Start

OTHER

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)

Delayed Start (Waitlist Control)

OTHER

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)

Interventions

Mindfulness-Based Stress Reduction (MBSR) BEHAVIORAL

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.

Delayed Start (Waitlist Control); Immediate Start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

RECRUITING

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Amanda Herrmann, PhD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meghan O'Brien, MPH

CONTACT

651-495-6363; Meghan.E.Obrien@HealthPartners.com

Bethany Crouse, PhD

CONTACT

bethany.k.crouse@healthpartners.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

US (1)