Evaluating a Novel Sleep-focused Mind-body Rehabilitative Program for Veterans With mTBI and Other "Polytrauma" Symptoms: An Randomized Controlled Trial (RCT) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in latency to sleep onset using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
研究概览
简要总结
The broad aim of the proposed study is to evaluate the comprehensive benefit of a novel mind-body therapeutic intervention, Mind-Body Bridging (MBB), in Veterans who suffer from mTBI and sleep disturbance co-morbid with PTSD and/or pain at the VA Salt Lake City Health Care System (VASLCHCS). Evidence for comprehensive benefit includes, but is not limited to, the average difference in outcomes between MBB and an active control, sleep education (SED), both integrated with the usual care for mTBI Veterans. The long-term goal of the proposed project is to introduce, implement and establish mind-body intervention programs as a behavioral health intervention modality that would serve as a generally sustainable health care intervention program before, during, and after deployment for military personnel.
详细描述
Traumatic brain injury represents a dynamic spectrum of physiologic and cognitive dysfunction that exerts effects at multiple levels of human health. Mild traumatic brain injury (mTBI) is a multi-factorial illness that is an increasingly serious public health issue for military and civilian personnel. The assessment of neurocognitive deficits in mTBI has been suggested to be less conclusive, presumably because of the predominating influence of PTSD and other co-morbid factors. Recent research suggests that psychological factors play a substantial role in TBI-related impairments in self-reported health and cognition function. Furthermore, research has shown that TBI is rarely an isolated finding in military combat settings and that persistent post-concussive symptoms are commonly associated with post-traumatic stress disorder and chronic pain, a constellation of findings that has been termed the "polytrauma clinical triad". Indeed, significant numbers of returning Veterans of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) display the polytrauma clinical triad (PCT) of pain, posttraumatic stress disorder (PTSD), and traumatic brain injury. The proposed project will: 1) elucidate best practices for treating mTBI with co-occurring symptoms (pain, sleep disturbance, PTSD) encompassing cognitive, emotional, and psychological functioning; and 2) address psychosocial aspects of managing pain and co-morbidities associated with mTBI through integrative and complementary and alternative approaches.
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 (Outcomes Assessor)
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
- 否
入选标准
- •Veteran from OEF/OIF
- •has been diagnosed with mTBI
- •has current sleep disturbance as indicated by a score of 35 or greater on the MOS-Sleep Scale (MOS-SS)
排除标准
- •serious psychiatric comorbidity
- •active intense suicidal intent
- •inpatient admission to psychiatric ward in the last 3 month
- •the presence of co-occurring progressive/advanced neurodegenerative disease
- •terminally ill
- •unstable chronic medical conditions
- •untreated sleep apnea
- •presence of substance dependence disorder
- •narcolepsy
- •frequent nocturia
- •delayed sleep phase syndrome
- •advanced sleep phase syndrome
研究组 & 干预措施
Mind-Body Bridging Program
The Mind-Body Bridging Program (MBBP) is an awareness training program (ATP) to help individuals improve their health condition and attain a state of well-being. Bridging is the primary technique that facilitates the healing process, by bringing one back to the present moment to experience thoughts, emotions and physical sensations. Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
干预措施: Mind-Body Bridging Program (Behavioral)
Supportive Education
Supportive Education program will provide educational lectures on disability, sleep hygiene, and current research on depression and non-directive, supportive discussions about these topics.
干预措施: Supportive Education (Behavioral)
结局指标
主要结局
Change in latency to sleep onset using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
时间窗: Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.
Change in self-reported measures of sleep using Medical Outcomes Study -Sleep Scale, from baseline (Pre) to 6 months follow-up
时间窗: Pre (within one month before Intervention week 1), Intervention week 1, Intervention week 2, Intervention week 3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The Medical Outcomes Study Sleep Scale (MOS-SS) provides an index of sleep problems and incorporates six sleep scale scores: 1) sleep disturbance, 2) sleep adequacy, 3) daytime somnolence, 4) snoring, 5) waking up short of breath with a headache, and 6) quantity of sleep. The MOS-SS is similar to the Pittsburgh Sleep Quality Index (PSQI) developed at the same time, which includes more questions about sleep disturbance with seven more items overall. The 1-week assessment is adapted from the normal 4-week retrospective assessment.
Change in self-reported mTBI symptoms using the Neurobehavioral Symptom Inventory (NSI), from baseline (Pre) to 6 months follow-up.
时间窗: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The NSI is a self-report measure of post-concussive symptoms comprising 22-items. Participants rate the degree of symptom severity on a five-point scale ranging from 0 (none) to 4 (very severe) over the past 2 weeks. The NSI total score is the sum of severity ratings of the 22 symptoms, and ranges from 0 to 88. The NSI reflects a 9 symptom cluster model, which can be validly reduced to 3 clusters, namely, cognitive, affective, and somatic/sensory symptoms.
Change in self-reported Quality of Life using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) for Veterans (MOS SF-36V), from baseline (Pre) to 6 months follow-up.
时间窗: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The MOS SF-36V is a well-established standard measure of quality of life (QOL) scale, to assess mental and physical health as well as functional status, adapted for Veterans. The MOS SF-36V consists of the same eight sections as the civilian version, MOS SF-36. Higher scores indicate better quality of life. The instrument provides a global score, as well as the following subscale scores: functional capacity, physical aspects, pain, general health condition, vitality, social aspects and emotional aspects, and mental health.
Change in duration of sleep using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
时间窗: Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.
Change in number of awakenings using the Sleep Diary, from baseline (Pre) to 6 months follow-up.
时间窗: Pre (within one month before Intervention week 1), Intervention week 2, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up
The Sleep Diary is a commonly used self-reported sleep assessment measure. Participants will be asked to complete a sleep diary for seven days. In the sleep diary, participants will record different daily events and activities (e.g., the number of times they wake up during the night, whether they have been drinking caffeinated beverages, or exercising). Sleep-related entries include recording when they go to bed, when they think they fell asleep, duration of sleep, and naps during the day.
Change in physical activity during sleep for assessment of sleep quality using a heart rate and motion detection device, from baseline (Pre) to 3 months follow-up
时间窗: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
The non-invasive heart rate and motion detection device will be used to quantify physical activity during sleep for assessment of sleep quality as a measure of sleep disturbance. Each participant will be asked to wear the device for 2 consecutive days of home assessment.
Change in heart rate variability for assessment of sleep quality using a heart rate and motion detection device, from baseline (Pre) to 3 months follow-up
时间窗: Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up
The non-invasive heart rate and motion detection device will be used to quantify heart rate variability for assessment of sleep quality as a measure of sleep disturbance. Each participant will be asked to wear the device for 2 consecutive days of home assessment.
次要结局
- Change in self-reported pain symptoms using the Brief Pain Inventory (BPI), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported depression symptoms using the Center for Epidemiologic Studies Depression Scale (CES-D), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported PTSD using the PTSD Checklist - Military Version (PCL-M), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported resilience using the Connor-Davidson Resilience Scale (CD-RISC), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported perceived stress symptoms using the Perceived Stress Scale (PSS), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), InterventionWeek1, InterventionWeek2, InterventionWeek3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported self-compassion using the Self-Compassion Scale (SCS), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported mindfulness using the Five Facet Mindfulness Questionnaire (FF-MQ), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), InterventionWeek1, InterventionWeek2, InterventionWeek3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported suicidal ideation using the Beck Scale for Suicide Ideation (BSI), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness (MAIA), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in sustained attention using the Computerized Cognitive Assessment, from baseline (Pre) to 3 months follow-up(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up)
- Change in self-reported well-being using the Well-Being Index (WBI), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), InterventionWeek1, InterventionWeek2, InterventionWeek3, Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in self-reported type D (distressed) symptoms using the Type D Scale-14 (TYPE-D), from baseline (Pre) to 6 months follow-up.(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up, 6 month Follow-up)
- Change in diurnal salivary cortisol levels, from baseline (Pre) to 3 months follow-up(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up)
- Change in diurnal salivary α-amylase levels, from baseline (Pre) to 3 months follow-up(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up)
- Change in salivary cortisol awakening response, from baseline (Pre) to 3 months follow-up(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up)
- Change in salivary α-amylase awakening response, from baseline (Pre) to 3 months follow-up(Pre (within one month before Intervention week 1), Post (one week after Intervention week 3), 3 month Follow-up)
研究者
Yoshio Nakamura
Research Associate Professor
University of Utah