Chronic Stroke PatientsNCT07491861
Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Chronic Stroke Patients, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Stroke Patients
- What is being tested?
- Mindfulness-Based Stress Reduction (MBSR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Neuroscience Center
Saint Paul, Minnesota, 55130
About this study
Official title: 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).
- Conditions
- Chronic Stroke Patients
- Being tested
- Mindfulness-Based Stress Reduction (MBSR)
- Keywords
- Mindfulness, MBSR, Chronic Stroke, Interoception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress Reduction (MBSR)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness-Based Stress Reduction (MBSR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of MBSR Intervention Feasibility by measuring class attendance
Feasibility of the MBSR intervention will be assessed by measuring attendance of the sessions
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Assessment of MBSR Intervention Feasibility through item 4 of the Client Satisfaction Questionnaire (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.
Measured: 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.
Measured: 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.
Measured: 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)
Higher scores indicate greater interoceptive awareness
Measured: From pre-intervention visit to end of treatment (~8 weeks)
Assessment of Interoception using the Body Perception Questionnaire short form (BPQ-SF)
Higher scores indicate more symptoms
Measured: From pre-intervention visit to end of treatment (~8 weeks)
Assessment of Emotional Wellbeing through the Personal Health Questionnaire 8-item (PHQ-8)
Higher scores indicate more severe depression
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Assessment of Emotional Wellbeing using the Generalized Anxiety Disorder 7-item (GAD-7)
Higher scores indicate more severe anxiety
Measured: 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)
A higher score indicates better mental well-being
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Assessment of Emotional Well-being using the Satisfaction with Life Scale (SWLS)
A higher score indicates greater satisfaction
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Assessment of Emotional Wellbeing through the Meaning in Life Questionnaire-Presence
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.
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Assessment of Whole Person Health using the Whole Person Health Index (WPHI)
A higher score indicates better or improving health
Measured: From pre-intervention visit to the end of treatment (~8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start9 Apr 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Herrmann, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491861
- Sponsor's protocol ID
- A26-010
- Status last verified
- Jun 2026
- First submitted
- 18 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoception and Emotional Recovery After Stroke: A Pilot Study of Mindfulness-Based Stress Reduction
- ClinicalTrials.gov ID
- NCT07491861
- Acronym / sponsor ID
- A26-010
- Conditions
- Chronic Stroke Patients
- Keywords
- Mindfulness, MBSR, Chronic Stroke, Interoception
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Start | Other | Behavioral: Mindfulness-Based Stress Reduction (MBSR)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. |
| Delayed Start (Waitlist Control) | Other | Behavioral: Mindfulness-Based Stress Reduction (MBSR)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Delayed Start (Waitlist Control), Immediate Start |
Primary outcome
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
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.
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.
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.
8 secondary outcomes
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)
Assessment of Interoception using the Body Perception Questionnaire short form (BPQ-SF)
Time frame: 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)
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)
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)
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)
Assessment of Emotional Wellbeing through the Meaning in Life Questionnaire-Presence
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda Herrmann, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stress Reduction (MBSR) in people with Chronic Stroke Patients, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of MBSR Intervention Feasibility by measuring class attendance (time frame: From pre-intervention visit to the end of treatment (~8 weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.