Implementation of Online Mindfulness-Based Stress Reduction Tailored for People with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Adherence
研究概览
简要总结
This project aims to implement and investigate a mindfulness-based stress reduction (MBSR) in people with multiple sclerosis (PwMS). The main objective is to implement MBSR intervention for PwMS in a major tertiary care clinic for PwMS. We will iteratively refine the intervention as required based on stakeholder feedback and any other emergent contextual findings.
Participants will be asked to take part in an 8-week MBSR course and report changes in anxiety, depression, quality of life, emotional regulation, self-compassion, mindfulness, and health services use.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 years </= 60 years
- •Diagnosis of MS or related condition (Clinically Isolated Syndrome, Neuromyelitis Optica Spectrum Disorder, Chronic Inflammatory Demyelinating Neuropathy)
- •Able to understand spoken and written English
- •Willing to take part in an MBSR course
排除标准
- •Cognitive impairment (<26 on the Montreal Cognitive Assessment)
- •Severe active mental health impairment (psychosis, suicidality)
- •Medical instability (terminal/life threatening inter-current illness)
结局指标
主要结局
Adherence
时间窗: 24 months
The investigators will measure the number of participants who completed the mindfulness-based stress reduction course.
Recruitment
时间窗: 24 months
The investigators will measure the number of participants eligible for and recruited to the study.
Retention
时间窗: 24 months
The investigators will measure the percentage of participants who complete outcome data.
Follow-up rates
时间窗: 24 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
- Quality of Life using the Multiple Sclerosis Impact Scale (MSIS-29)(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Anxiety(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Sleep(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Pain Effects(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Quality of Life using the EuroQol (EQ-5D-5L)(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Health services use(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)
- Depression(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)
- Mindfulness(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Climate(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Therapeutic alliance(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Fatigue(Measured at baseline, 8-week follow-up, and 3-month follow-up)
- Cognitive function(Measured at baseline, 8-week follow-up, and 3-month follow-up)
研究者
Robert Simpson
Investigator
Unity Health Toronto