Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

March 30, 2026 updated by: HealthPartners Institute

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-intervention visit to the end of treatment (~8 weeks)
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.
3-month recruitment period
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.
From enrollment to end of study (approximately 16 weeks)
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.
From pre-intervention visit to end of treatment (~8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From pre-intervention visit to end of treatment (~8 weeks)
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
From pre-intervention visit to end of treatment (~8 weeks)
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
From pre-intervention visit to the end of treatment (~8 weeks)
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
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)
Time Frame: From pre-intervention visit to the end of treatment (~8 weeks)
A higher score indicates better mental well-being
From pre-intervention visit to the end of treatment (~8 weeks)
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
From pre-intervention visit to the end of treatment (~8 weeks)
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.
From pre-intervention visit to the end of treatment (~8 weeks)
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
From pre-intervention visit to the end of treatment (~8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Investigators

  • Principal Investigator: Amanda Herrmann, PhD, HealthPartners Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A26-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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