Online Mindfulness-based Stress Reduction Intervention for Chronic Pain in Individuals Waiting for Health Care Services: a Study Protocol for a Pilot Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Participants retention rate
研究概览
简要总结
The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
It is not possible to blind the participants to group allocation due to the nature of the mindfulness-based stress reduction intervention; however, the outcome assessor, who will administer the outcome questionnaires to the participants will be blinded to the participants' group allocation as well the investigator and the data analyst who will conduct the analysis ensuring neutrality of the outcome assessment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18-85
- •Self-reported diagnosis of chronic non-cancer pain
- •Chronic non-cancer pain duration of 3 months or more
- •Chronic non-cancer pain experienced during 4 days or more per week
- •Average pain intensity of 4 or more out of 10 in the last seven days
- •French or English fluency
- •Access to Wi-Fi
- •Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks
排除标准
- •Cancer-related chronic pain
- •Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
- •Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
- •Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
结局指标
主要结局
Participants retention rate
时间窗: 2 months
The percentage of participants who have completed the 8 online MBSR sessions
Participants participation rate
时间窗: 12 months
The percentage of participants on waiting lists who agreed to participate in the intervention
次要结局
- Patient-Reported Outcomes Measurement Information System 29(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
- French-Canadian Chronic Pain Self-Efficacy Scale(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
- Global Rating of Change Scale(3-month follow-up (week 21))
- Chronic Pain Acceptance Questionnaire(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
- Pain Disability Index(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
- Patient-Reported Outcomes Measurement Information System Global-10(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
- Pain Catastrophizing Scale(Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21))
研究者
Diana Zidarov
site researcher
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal