Mindfulness Interventions and Chronic Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Feasibility and retention
研究概览
简要总结
The primary objective of this study to determine the feasibility and acceptability of a mindfulness intervention for adolescents with juvenile fibromyalgia/ chronic widespread pain and other similar chronic symptoms.
详细描述
The primary objective is to test the feasibility, safety, tolerability and acceptability of a mindfulness meditation intervention for adolescents with juvenile fibromyalgia/chronic widespread pain.
The purpose of the program is to test how effective an 8-week meditation and stress reduction class is in helping adolescents with chronic symptoms (including but not limited to fibromyalgia or chronic widespread pain, irritable bowel syndrome, joint pain, chronic fatigue, and others).
Participants will attend group sessions led by an instructor experienced in MBSR in an academic setting. The mindfulness meditation group sessions will take place at the Yale School of Medicine.
Participants will attend 90-minute weekly group sessions and a 4-hour retreat with approximately 6-8 other study participants at Yale School of Medicine. Participants are asked to practice at home by listening to pre-recorded 15-20 minute guided meditations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2010 American College of Rheumatology (ACR) criteria based on the Widespread Pain Index (WPI) and Symptom Severity (SS) checklist.
- •Functional Disability Score ≥13 indicating at least moderate disability
- •Average pain intensity in the past week ≥ 4 on a 0-10 cm Visual Analog Scale.
- •Access to mobile telephone/smartphone with text messaging plan in order to receive survey questions.
- •Chronic symptoms such as fatigue, pain, bowel dysfunction, perceived cognitive impairment, or other non-specific symptoms persisting for 3-months or more, severe enough to have led to more than one visit to a medical provider. These symptoms must have not been found to be due to a definable general medical disorder despite adequate evaluation.
排除标准
- •Diagnosis of an autoimmune or rheumatologic disease
- •Current regular mindfulness meditation activity
- •Serious illness (including mental illness/psychopathology) within 90 days prior to screening
- •Inability or unwillingness of a parent to give consent/permission or child to assent
- •Current use of opioid analgesics
- •Current prescription for antidepressant medications
- •Screening positive on the Columbia Suicide Screen (CSS)
- •Active participation (weekly or more often) in a fibromyalgia or chronic disease support group
结局指标
主要结局
Feasibility and retention
时间窗: 8 weeks
Feasibility and retention will be assessed after each cohort completes the group sessions. Feasibility of the intervention will be assessed by the proportion of eligible patients approached for the study who consent to participate and the proportion of the weekly sessions that are attended.
次要结局
- Program Practicality(8 weeks)
- Program Adherence(8 weeks)
- Program Use(8 weeks)
- Functional Disability Inventory (FDI)(8 weeks)
- Juvenile Revised Fibromyalgia/Symptom Impact Questionnaire (FIQR/SIQR)(8 weeks)
- Pediatric Quality of Life Inventory (PedsQL) 4.0 (Adolescent Form)(8 weeks)
- Perceived Stress Scale (PSS)(8 weeks)