Self-compassion for People with Multiple Sclerosis: an Exploratory Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
The goal of this clinical trial is to develop and investigate a compassion-based intervention (Mindful Self-Compassion course) in people with multiple sclerosis. The main objectives are:
- Explore feasibility of trial processes including recruitment, adherence, retention, and follow-up
- Explore experiences of people with multiple sclerosis with the Compassion-based intervention, including perceived effects, barriers and facilitators to participation, suggestions for improvement
- Determine potential effects on stress, anxiety, depression, emotion regulation, illness adjustment, and self-compassion.
Participants will be asked to take part in an 8-week online Mindful Self-Compassion course and report changes in levels of stress, anxiety, depression, self-compassion, adjustment, emotion, and quality of life from pre- to post-intervention and at 3-month follow-up. Additionally, participants will be asked to take part in a semi-structured interview to explore their experiences with the course, perceived effects, and suggestions for improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- •Aged 18 years or older
- •Able to understand spoken and written English
- •Have a neurologist-confirmed diagnosis of multiple sclerosis
- •Willing to take place in an Mindful Self Compassion course
排除标准
- •Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- •Severe active mental health impairment (psychosis, suicidality)
结局指标
主要结局
Adherence
时间窗: 4 months
The investigators will measure the number of participants who completed the mindful self-compassion course.
Recruitment
时间窗: 4 months
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
时间窗: 4 months
The investigators will measure the percentage of participants who complete outcome data.
Follow-up rates
时间窗: 4 months
The investigators will measure the percentage of participants who complete outcome measures pre-intervention, post-intervention, and at 3 months post-intervention.
次要结局
- Anxiety(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Depression(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Stress(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Self-compassion(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Emotion Regulation(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Adjustment(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
- Participant Experiences and Perspectives(Measured at baseline, 8-week follow-up, and 3-month follow-up.)
研究者
Robert Simpson
Investigator
Unity Health Toronto