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临床试验/NCT04253691
NCT04253691进行中(未招募)不适用

Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study

University of Missouri-Columbia2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年2月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
30
试验地点
2
主要终点
Daily Electronic Sleep/Pain Diaries

研究概览

简要总结

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70% of patients reporting sleep difficulties. It is well documented that, alongside a high comorbidity with chronic pain, chronic insomnia also has high comorbidity with, and is a risk factor for, developing an anxiety disorders. This clinical trial will examine the effects of virtual reality (VR) meditation environments on patients with pain- and insomnia-related anxiety. The purpose of this study is to examine the benefits of using VR meditation with patients with chronic pain and chronic sleep disturbance so that clinicians can more effectively treat core causes to symptoms and reduce counterproductive therapies.

Research objectives include:

  1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
  2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
  3. To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
  4. To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).

详细描述

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70% of patients reporting sleep difficulties. It is well documented that, alongside a high comorbidity with chronic pain, chronic insomnia also has high comorbidity with, and is a risk factor for, developing an anxiety disorders. Research has shown that Cognitive Behavioral Therapies (CBT) are efficacious in treating patient with comorbid insomnia and chronic pain (e.g., improvements in sleep parameters, normal sleep efficiency, reductions in pain severity. CBT addresses a number of factors involved in the maintenance of patient sleep and health issues, and a key piece of CBT for insomnia and pain is the reduction of worrisome thoughts, or anxiety related to sleep and pain issues. A common evidence-based strategy used for reducing anxiety and worry is the practice of relaxation. The aim of this study is to investigate the benefits of replacing treatment as usual (TAU) relaxation practices, with Virtual Reality (VR) mediation environments within CBT treatment.

Virtual Reality Meditation for Anxiety

There are few studies in the literature demonstrating a relationship between Virtual Reality (VR) - a computer generated environment that presents the user with a realistic three-dimensional space - and reductions in anxious symptomology. However, the results of those studies are very encouraging. In a case study, Tarrant and Cope treated 4 firefighters who had anxiety and anxiety-based disorders with a Positivity VR Experience. 3 of 4 treated patients exhibited increased left gamma symmetry, associated with approach behavior and increased mood, and 3 of 4 patients showed increases in State-Cheerfulness and Positive Affect. Tarrant and colleagues also conducted a pilot study, where they treated 14 patients who had moderate or higher levels of generalized anxiety with a 5-minute Mindfulness in Nature experience. Patients in the VR meditation group showed both global and regional decreases in Beta activity (i.e., decrease in frequencies associated with qualitatively anxious states and decreased self-reported State Anxiety. Overall, these results seem promising, as they provide preliminary evidence supporting that VR interventions may be a useful and effective tool for the treatment of elevated anxiety symptoms.

In summary, this clinical trial will examine the effects of VR meditation environments on patients with pain- and insomnia-related anxiety. The proposed study design will yield important information about the efficacy of VR meditation practices. The purpose of this study is to examine the benefits of using VR meditation with patients with chronic pain and chronic sleep disturbance so that clinicians can more effectively treat core causes to symptoms and reduce counterproductive therapies.

Ultimately, this research targets two important public health concerns, namely insomnia and chronic pain. Insomnia in the context of chronic pain has been relatively understudied. Thus, the results of the present study will provide unique insights into sleep and chronic pain and will advance knowledge in the fields of both sleep and pain. Although the results of this study will be specific to chronic pain patients, they will have broader implications for other medical populations likely to suffer from chronic pain and insomnia (i.e., cancer patients, older adults). The information gained has the potential to make a significant contribution to behavioral healthcare practices for a wide variety of disorders, not just insomnia and pain. Thus, this research has implications not only for future sleep and pain research but also for other types of treatment-related research.

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

入选标准

  • General inclusion criteria:
  • able to read and understand English,
  • pain and insomnia complaints for 6+ months,
  • diagnosed with (4.1) insomnia based on the criteria below:
  • 4.1) insomnia complaints for 6+ months that:
  • 4.1a) occur despite adequate opportunity and circumstances for sleep, and
  • 4.1b) consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep,
  • 4.1c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,
  • 4.1d) screening ISI score ≥ 11

排除标准

  • unable to provide informed consent,
  • unable to complete forms and implement treatment due to cognitive impairment (MMSE<26),
  • sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI>15], Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour > 15]),
  • bipolar or seizure disorder (due to risk of sleep restriction treatment),
  • other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders),
  • severe untreated psychiatric comorbidity,
  • psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep,
  • participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue or mood outside the current study

研究组 & 干预措施

Virtual Reality Based Relaxation Therapy

Experimental

This is a pilot trial with one treatment condition (VR mediation).

干预措施: Virtual Reality Mediated Relaxation (Device)

结局指标

主要结局

Daily Electronic Sleep/Pain Diaries

时间窗: 6 weeks

Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption

Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset)

时间窗: 6 weeks

Objective wake after sleep onset

Fatigue Severity Scale

时间窗: 6 weeks

Fatigue severity; min:10 max: 73; higher score means higher fatigue severity

Objective Daily Sleep Actiwatch-2 (Sleep Onset Latency)

时间窗: 6 weeks

Objective sleep onset latency

Insomnia Severity Index

时间窗: 6 weeks

Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity

Objective Daily Sleep Actiwatch-2 (Sleep Efficiency)

时间窗: 6 weeks

Objective sleep efficiency

次要结局

  • Computerized Cognitive Assessments - Sternberg tasks(6 weeks)
  • State Trait Anxiety Inventory(6 weeks)
  • Patient centered outcomes questionnaire(6 weeks)
  • Cognitive Failures Questionnaire(6 weeks)
  • Computerized Cognitive Assessments -WCST(6 weeks)
  • Computerized Cognitive Assessments - Stroop Task(6 weeks)
  • List learning-Rey Auditory Learning Test modified for visual presentation(6 weeks)
  • Beck Depression Inventory Second Edition(6 weeks)

研究者

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

Christina McCrae

Professor

University of Missouri-Columbia

研究点 (2)

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