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临床试验/NCT02800720
NCT02800720已完成不适用

Meditation Awareness Training for the Treatment of Fibromyalgia Syndrome: A Randomised Controlled Trial

Nottingham Trent University0 个研究点目标入组 148 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
主要终点
Short Form McGill Pain Questionnaire

研究概览

简要总结

A Randomised Controlled Trial to evaluate the effectiveness of a Second-Generation Mindfulness-Based Intervention known as Meditation Awareness Training (MAT) for treating fibromyalgia syndrome.

详细描述

Background: Fibromyalgia syndrome (FMS) is a chronic pain disorder that frequently leads to poor quality of life. The need for more effective FMS treatments has prompted empirical investigations into the applications of mindfulness for treating the condition. However, studies have predominantly focused on first-generation mindfulness-based interventions (FG-MBIs). To date, a randomised controlled trial (RCT) assessing the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating FMS has not been undertaken. SG-MBIs are distinct from FG-MBIs because they are overtly spiritual in nature and employ (i) a greater range of (normally secularised) meditative/spiritual techniques, (ii) ethics as a key component of the taught programme, and (iii) an instructor training programme that typically requires several years of supervised mindfulness practice.

Aims: To evaluate the effectiveness of Meditation Awareness Training (MAT) - an SG-MBI - for treating FMS.

Method: Adults with FMS will receive MAT or an active control intervention known as Cognitive-Behavioural Therapy for Groups. Assessments will be performed at pre-intervention, post-intervention, and follow-up phases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current diagnosis of fibromyalgia syndrome
  • Aged between 18 and 65 years
  • Able to read and write using the English language
  • Available to complete an eight-week intervention and six-month follow-up assessment

排除标准

  • Currently undergoing formal psychotherapy
  • Changes in psychopharmacology type or dosage one-month prior to intervention
  • Currently practicing mindfulness or meditation

结局指标

主要结局

Short Form McGill Pain Questionnaire

时间窗: 8 weeks

Scale Reference: Melzack (1987)

Depression Anxiety and Stress Scale

时间窗: 8 weeks

Scale Reference: Lovibond \& Lovibond (1995)

Revised Fibromyalgia Impact Questionnaire

时间窗: 8 weeks

Scale Reference: Bennett, Friend, Jones, Ward, Han \& Ross (2009)

Pittsburgh Sleep Quality Index

时间窗: 8 weeks

Scale Reference: Buysse, Reynolds Monk, Berman, \& Kupfer (1989)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Van Gordon

Principal Investigator

Nottingham Trent University

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