Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

N/AActive Not RecruitingNCT07491861

HealthPartners Institute28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Chronic Stroke Patients

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Assessment of MBSR Intervention Feasibility by measuring class attendance

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Secondary Outcomes

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

Higher scores indicate greater interoceptive awareness

Time frame: 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

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)

Higher scores indicate more severe depression

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)

Higher scores indicate more severe anxiety

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)

A higher score indicates better mental well-being

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)

A higher score indicates greater satisfaction

Time frame: 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.

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)

A higher score indicates better or improving health

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

Mindfulness-Based Stress Reduction for Emotional Recovery After Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes