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临床试验/NCT00768781
NCT00768781已完成2 期

Augmenting Behavior Therapy for Insomnia With Mindfulness Meditation

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
54
试验地点
2
主要终点
Pre-Sleep Arousal Scale (PSAS) total score

研究概览

简要总结

The overall goal of this project is to evaluate the evidence for the efficacy of two mindfulness-based interventions, mindfulness-based therapy for insomnia (MBT-I) and mindfulness-based stress reduction (MBSR), for reducing arousal and improving sleep among individuals with psychophysiological insomnia.

Specific Aim 1: To obtain evidence for the relative effects of MBT-I and MBSR compared to a delayed-treatment control condition followed by behavior therapy for insomnia (BT-I) on arousal levels. It is hypothesized that MBSR and MBT-I will be superior to the control condition at reducing arousal levels.

Specific Aim 2: To obtain evidence for the relative effects of MBT-I, MBSR, and the delayed-treatment control on sleep. It is hypothesized that MBT-I will be superior to the MBSR and control conditions at improving sleep parameters.

Specific Aim 3: To investigate the relationship between measures of arousal (self-report and objective measures) and sleep (self-report and objective measures) to enhance the understanding of the role of arousal in psychophysiological insomnia.

详细描述

The conceptual model for this study identifies two possible targets of treatment: arousal and sleep. In this model, BT for insomnia directly targets nighttime symptoms of insomnia (BT pathway), which improves sleep by increasing the homeostatic drive for sleep. Although BT is hypothesized to indirectly reduce arousal, no study has specifically investigated this effect. In contrast, MBSR is an intervention that is hypothesized to target arousal and, as preliminary findings suggest, also improves some symptoms of insomnia (MBSR pathway). It is therefore hypothesized that a combination of BT and mindfulness is superior to each treatment alone as it targets both nighttime symptoms and hyperarousal (Mindfulness + BT pathway). Our preliminary data suggests that this combination treatment has effects on both self-reported arousal and sleep. Conceptually, this novel approach would provide a set of self-regulating skills that could potentially target a broader range of daytime and nighttime symptoms that is characteristic of an insomnia disorder.

To test the conceptual model, this study employs a randomized clinical trial design with three conditions: 1) Mindfulness-Based Therapy for insomnia (MBT-I), 2) mindfulness-based stress reduction (MBSR), and 3) delayed-treatment condition followed by behavior therapy for insomnia (BT-I). Each of the three treatments will be delivered in a group format with 8 weekly sessions spanning an 8-week period.

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
None

入排标准

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

入选标准

  • Meets criteria for psychophysiological insomnia
  • Males and females of age 21 or older

排除标准

  • Unstable medical condition that is known to impact sleep
  • Psychiatric conditions likely to impact the practice of meditation
  • Current active suicidal ideation
  • Presence of a primary sleep disorder other than primary insomnia
  • Evidence of paradoxical insomnia
  • Evidence of idiopathic insomnia
  • Frequent use of alcohol at bedtime
  • Excessive daily caffeine consumption
  • Current use of sleep medications on a regular basis
  • Inadequate proficiency in English
  • Inability to commit to attending therapy sessions due to schedule conflicts
  • Women who are pregnant

结局指标

主要结局

Pre-Sleep Arousal Scale (PSAS) total score

时间窗: Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up

Sleep Diaries (Total Wake Time)

时间窗: Baseline, post-txt, 6 month follow-up

次要结局

  • Actigraphy measures of sleep/wake time(Baseline, during txt, post-txt, 3 month follow-up, 6 month follow-up)
  • Polysomnographic measures of sleep parameters(Baseline, post-txt, 6 month follow-up)
  • Insomnia Severity Index (ISI) total score(Baseline, post-txt, 3 month follow-up, 6 month follow-up)
  • Five Factor Questionnaire (Mindfulness Skills) Total score(Baseline, post-txt, 3 month follow-up, 6 month follow-up)
  • Dysfunctional Beliefs and Attitudes about Sleep (DBAS) score(Baseline, post-txt, 3 month follow-up, 6 month follow-up)
  • Hyperarousal Scale (HAS) score(Baseline, post-txt, 3 month follow-up, 6 month follow-up)
  • Heart Rate variability (HR)(Baseline, post-treatment, 6-month follow-up)

研究者

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

Jason C. Ong, PhD

Assistant Professor

Rush University Medical Center

研究点 (2)

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