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临床试验/NCT02478307
NCT02478307已完成1 期

Mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for Low Back Pain

The University of Queensland2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
69
试验地点
2
主要终点
Pain interference PROMIS scale

研究概览

简要总结

Up to 80% of Australians experience back pain and 10% have significant disability as a result. There is a critical need for the development and evaluation of innovative treatments that have the capacity to target the multidimensional nature of chronic low back pain. This study will compare the effects and mechanisms of Mindfulness Meditation, Cognitive Therapy, and Mindfulness-Based Cognitive Therapy for chronic low back pain. Results will ultimately lead to streamlined interventions designed to efficiently maximise benefit.

详细描述

Up to 80% of Australians experience back pain and 10% have significant disability as a result. This translates into substantial economic cost with far reaching psychological, emotional and social implications. Unfortunately, the treatment options for chronic low back pain (CLBP) are limited and typical medical/pharmacological approaches entail potentially serious side-effects (e.g., opioid addiction). There is a critical need for the development and evaluation of innovative interventions that have the capacity to target the multidimensional nature of CLBP.

Research indicates that psychosocial interventions for CLBP are viable treatment approaches that entail few (if any) deleterious side effects and can have benefit beyond pain reduction. Cognitive Therapy (CT) and Mindfulness Meditation (MM) have both been found to be feasible and effective for CLBP. A promising recently developed treatment that combines aspects of CT and MM is Mindfulness-Based Cognitive Therapy (MBCT). MBCT has been successfully applied to problems such as depression and headache; however, this approach has not been investigated for CLBP.

Thus, the current study is a randomised controlled trial (RCT) designed to examine the effects and mechanisms (i.e., how and for whom do these treatments work) of CT, MM, and MBCT for CLBP. Brain state data (electroencephalogram (EEG)) as well as self-report data will be examined to investigate the potential unique and shared mechanisms underlying treatment effects. Furthering the field's understanding of these treatments and their mechanisms will lead to the development of streamlined interventions designed to efficiently maximise benefit for individuals with CLBP, and that optimise relief from suffering.

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 (Participant)

入排标准

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

入选标准

  • ≥18 years of age
  • Chronic pain of the low back (≥3 months) that is the primary source of reported pain
  • Average pain intensity of ≥4 on a 10-point scale
  • If currently taking analgesic or psychotropic medications, they must have been stabilised for ≥4 weeks prior to this study
  • Be able to read, speak and understand English
  • Be able to attend a weekly 2-hour therapy session for 8 concurrent weeks

排除标准

  • Cognitive impairment, uncontrolled psychotic symptoms or current elevated suicidal ideation as this may interfere with group-delivered therapy (as evidenced by the 6-item screener)
  • Chronic pain due to malignancy
  • History of a medical condition that could produce an abnormal EEG and interfere with the tests of the effects of treatment on EEG (e.g., epilepsy, history of traumatic brain injury)
  • Currently receiving other psychosocial pain treatment

研究组 & 干预措施

Cognitive Therapy

Active Comparator

Eight, 2-hours sessions of group delivered cognitive therapy.

干预措施: Cognitive Therapy (Other)

Mindfulness Meditation

Active Comparator

Eight, 2-hours sessions of group delivered mindfulness meditation.

干预措施: Mindfulness Meditation (Other)

Mindfulness-Based Cognitive Therapy

Active Comparator

Eight, 2-hours sessions of group delivered mindfulness-based cognitive therapy

干预措施: Mindfulness-Based Cognitive Therapy (Other)

结局指标

主要结局

Pain interference PROMIS scale

时间窗: pre to post-treatment (at least 8 weeks)

Participants are assessed pre-treatment and then following the 8-week treatment (post-treatment); change in pain interference is assessed via the PROMIS scale

次要结局

  • Psychological functioning PROMIS scale(pre to post-treatment (at least 8 weeks))
  • Physical functioning PROMIS scale(pre to post-treatment (at least 8 weeks))
  • Delta, theta, alpha, beta, and gamma bands assessed via EEG(pre to post-treatment (at least 8 weeks))
  • Pain intensity assessed via the numerical rating scale (NRS)(pre to post-treatment (at least 8 weeks))
  • Pain catastrophizing assessed via the Pain Catastrophizing Scale(pre to post-treatment (at least 8 weeks))
  • Mindfulness assessed via the FFMQ(pre to post-treatment (at least 8 weeks))
  • Pain acceptance assessed via the CPAQ(pre to post-treatment (at least 8 weeks))
  • Emotional functioning PROMIS scale(pre to post-treatment (at least 8 weeks))

研究者

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

Dr Melissa Day

NHMRC Early Career Fellow

The University of Queensland

研究点 (2)

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