The Effect of Mindfulness Based Stress Reduction (MBSR) on Patients With Traumatic Brain Injury and Chronic Insomnia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Decrease in total score of Insomnia Severity Index (ISI) scale.
研究概览
简要总结
To evaluate the effects of Mindfulness Based Stress Reduction (MBSR) as an adjunct to usual clinical care for treatment of stress and chronic insomnia for patients with mild to moderate traumatic brain injury (MTBI). MBSR is a standardized protocol of meditation and yoga that has been studied extensively in other populations, however the effects of MBSR have not yet been well studied in the proposed population of service members with a Traumatic Brain Injury (TBI) who are experiencing insomnia.
详细描述
Randomized, controlled trial with 1:1 randomization (n=50). The control group will receive the usual care for TBI through the clinical program with standard providers based on usual patient evaluation and needs. The intervention group will receive MBSR in addition to the usual care through the TBI program.
The usual care pathway will include physician visits, rehabilitation therapies (PT/OT/ST/et al), and other providers as needed based on recommendations by his or her providers. Some variability will exist, but withholding standard of care would be unethical and standardizing care would be impossible. However, providers will be asked that medications, et al that could affect sleep remain unchanged during the trial period (maximum 12 weeks), which is reasonable given that patients have a chronic injury and no emergent/acute needs based on inclusion/exclusion criteria.
Subjects in a control group will be offered complimentary MBSR after 6 month follow up visit is completed.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild-to-moderate TBI (as defined by the DoD criteria)
- •Right-handedness
- •Insomnia Severity Index ≥15
- •DEERS eligible at the time of enrollment
- •Not pregnant
- •Male and female subjects 18 to 60 years old
- •Insomnia disorder per DSM-V criteria
排除标准
- •Inability to speak or understand English (because this is a group intervention, it requires a common language)
- •Patients who require assistance with activities of daily living (ADLs)
- •Active practice of meditation and/or yoga or participation in meditation/yoga classes in the last 6 months prior to enrollment
- •Signs or symptoms of upper motor neuron syndrome, any major systemic illness or unstable condition which could interfere with protocol compliance
- •Active psychiatric disease that would interfere with participation in the trial, psychotic features, agitation, or behavioral problems within the last 3 months that could interfere with protocol compliance
- •A history of alcohol/substance abuse or dependence within the past 6 months
- •Any neurosurgical intervention affecting brain parenchyma
- •Unstable seizure activity
- •Concurrent participation in another clinical research trial with investigational drug or previous participation with the last investigational drug administered less than 4 weeks prior to screening
- •Females who are pregnant or planning to become pregnant in 6 months following screening.
研究组 & 干预措施
MBSR treatment
MBSR will be administered over 8 week period.
干预措施: MBSR (Behavioral)
Control group
Usual care will continue for this group.
结局指标
主要结局
Decrease in total score of Insomnia Severity Index (ISI) scale.
时间窗: Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion
compare change in Insomnia Severity Index (ISI, score range 0-28) scores at baseline, 2 week follow up and 6 month follow up. ISI measures severity of insomnia and calculated by adding the scores for all seven items. Results interpretation: 0-7 = No clinically significant insomnia; 8-14 = Subthreshold insomnia; 15-21 = Clinical insomnia (moderate severity); 22-28 = Clinical insomnia (severe). A 6 point decrease is considered clinically significant improvement in symptoms of insomnia.
次要结局
- Change in cognitive function as measured by NIH toolbox(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in FSS (Fatigue Severity Scale score)(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in RAND-36 (RAND corporation 36 item Health Survey) score(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in PCL-5 (Post Traumatic Stress Disorder Check List-5) score(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in PHQ-9 (Patient Health Questionnaire 9) score(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in MAAS (Mindful Attention Awareness Scale score)(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in PSS (Perceived Stress Scale)(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Change in NSI (Neurobehavioral Symptom Inventory scale) score(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Any changes in blood biomarkers(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)
- Changes in SE- sleep efficiency measured by actigraphy devices and polysomnography.(Change in the score at baseline, 2 week follow up post treatment completion, 6 months follow up post treatment completion)