Interoception and Emotional Recovery After Stroke: A Pilot Study of Mindfulness-Based Stress Reduction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Assessment of MBSR Intervention Feasibility by measuring class attendance
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to consent to study participation
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
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.
干预措施: Mindfulness-Based Stress Reduction (MBSR) (Behavioral)
结局指标
主要结局
Assessment of MBSR Intervention Feasibility by measuring class attendance
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: From enrollment to end of study (approximately 16 weeks)
Retention will be measured by assessing number of recruited participants who complete all study visits.
次要结局
- Assessment of Emotional Wellbeing through the Personal Health Questionnaire 8-item (PHQ-8)(From pre-intervention visit to the end of treatment (~8 weeks))
- Improvement of Interoception as assessed by the Multidimensional Assessment of Interoceptive Awareness (MAIA)(From pre-intervention visit to end of treatment (~8 weeks))
- Assessment of Interoception using the Body Perception Questionnaire short form (BPQ-SF)(From pre-intervention visit to end of treatment (~8 weeks))
- Assessment of Emotional Wellbeing using the Generalized Anxiety Disorder 7-item (GAD-7)(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)(From pre-intervention visit to the end of treatment (~8 weeks))
- Assessment of Emotional Well-being using the Satisfaction with Life Scale (SWLS)(From pre-intervention visit to the end of treatment (~8 weeks))
- Assessment of Emotional Wellbeing through the Meaning in Life Questionnaire-Presence(From pre-intervention visit to the end of treatment (~8 weeks))
- Assessment of Whole Person Health using the Whole Person Health Index (WPHI)(From pre-intervention visit to the end of treatment (~8 weeks))