Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

June 15, 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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Saint Paul, Minnesota, United States, 55130
        • HealthPartners Neuroscience Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HealthPartners Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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