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NCT Number: NCT07491861

Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Stroke Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Mindfulness-Based Stress Reduction (MBSR)

Behavioral

MBSR consists of teaching meditation practices through breath and body awareness, 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.

Primary outcomes

  1. Assessment of MBSR Intervention Feasibility by measuring class attendance

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

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

  2. Assessment of MBSR Intervention Feasibility through item 4 of the Client Satisfaction Questionnaire (CSQ-8)

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

    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.

  3. Assessment of Study Feasibility through measurement of participant recruitment

    Time frame: 3-month recruitment period

    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.

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

    Time frame: From enrollment to end of study (approximately 16 weeks)

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

Secondary outcomes

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

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

    Higher scores indicate greater interoceptive awareness

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

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

    Higher scores indicate more symptoms

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

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

    Higher scores indicate more severe depression

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

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

    Higher scores indicate more severe anxiety

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

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

    A higher score indicates better mental well-being

  6. Assessment of Emotional Well-being using the Satisfaction with Life Scale (SWLS)

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

    A higher score indicates greater satisfaction

  7. Assessment of Emotional Wellbeing through the Meaning in Life Questionnaire-Presence

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

    The 5-item presence subscale of the Meaning in Life Questionnaire measures the degree to which individuals feel their lives are full of meaning and purpose. A higher score indicates stronger levels of perceived meaning.

  8. Assessment of Whole Person Health using the Whole Person Health Index (WPHI)

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

    A higher score indicates better or improving health

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

Interoception and Emotional Recovery After Stroke: A Pilot Study of Mindfulness-Based Stress Reduction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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