Characterization of Sleep With Trauma Nightmares Using Ambulatory Sleep Measurement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in Actigraphy-derived sleep efficiency (SE)
研究概览
简要总结
Trauma-related nightmares in Veterans are associated with poor clinical outcomes, greater substance use, and increased risk of suicide. In spite of an urgent need to reduce the burden of trauma-related nightmares, the underlying physiological changes associated with them are poorly understood, and there are no clear evidence-based recommendations for their treatment. Limitations of current assessment procedures represent a barrier to improved care. In-laboratory sleep studies rarely capture nightmares, limiting the knowledge about them and their response to treatment. This study addresses these limitations by using extended, in-home sleep monitoring to capture sleep data associated with nightmare reports in Veterans, and assessing how these features are altered throughout a cognitive-behavioral nightmare treatment. Results from this study will increase understanding of trauma-related nightmares, and advance strategies for personalizing symptom management for Veterans.
详细描述
There is a critical need for continued research to better understand trauma-related nightmares with the goal of developing personalized treatment plans. Limitations of current assessment procedures present a significant barrier to improved care. In-laboratory sleep studies rarely capture nightmares and cannot assess change over time, reducing the knowledge of phenotypic markers of nightmares to guide treatment. Therefore, there is a need to assess sleep over multiple nights in the home environment, where nightmares occur. This study aims to significantly enrich knowledge about trauma-related nightmares by using a zero-burden, multi-night, objective sleep measurement method within Veterans' usual sleeping environment prior to and during an evidence-based cognitive-behavioral intervention for nightmares. This study has two primary aims: 1) to identify, with greater precision than previously possible, objective features of sleep associated with trauma-related nightmare occurrences; and 2) to use the treatment for nightmares as interventional probes to determine whether and how changes in sleep physiological parameters identified in Aim 1 covary with changes in subjective nightmare frequency and severity.
The study will include 80 trauma-exposed Veterans reporting with trauma-related nightmares. Eligible participants will monitor their sleep for a week using a multi-night mattress actigraphy implemented in their home. Mattress actigraphy, which measures movements using accelerometers embedded in a mattress topper, employs no body surface sensors. Therefore, this system represents a truly zero-burden method for obtaining intensive longitudinal sleep measurement. During the week of sleep monitoring, participants also will complete one-night of polysomnography (PSG) sleep assessment to calibrate the actigraphic sleep efficiency and to identify untreated sleep apnea. These methods will be used to investigate candidate physiological parameters associated with trauma-related nightmares. After establishing the levels of these candidate markers, this project will assess the impact of a cognitive-behavioral treatment, Exposure, Relaxation, and Rescripting Therapy (ERRT), on the subset of markers which can be measured continuously over the course of the treatment. Participants will be randomized to five weeks of active treatment (ERRT; n = 40) or to five weeks of the comparison treatment (sleep and nightmare management; n = 40). Throughout the course of treatment, participants will continue to sleep while monitored by the mattress actigraphy system. Upon completion of treatment, a post-treatment and follow-up assessment will assess subjective symptom change. Results from this study will provide important information to facilitate increased understanding of the phenomenology, pathophysiology, and treatment of nightmares in trauma-exposed Veterans.
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)
盲法说明
Assessors at the post-treatment and follow-up assessment will not be aware of what treatment the participants received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a Veteran enrolled to receive VA medical care at the Minneapolis VA Health Care System
- •Have stable housing for the duration of the study period
- •Have experienced any traumatic event meeting Criterion A for PTSD at least three months before the baseline assessment
- •Meet criteria for a current PTSD diagnosis or subthreshold PTSD diagnosis
- •Self-report experiencing trauma-related nightmares at least once per week for the past month, that are mostly-remembered and that cause awakening
- •Self-report global sleep disturbance indicated by a score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI)
- •Be stable on any psychoactive medications for a minimum of two weeks before the baseline assessment
排除标准
- •Inability to provide fully-informed written consent to participate and/or a bed partner does not agree to mattress recording during the in-home portion of the study
- •Medical conditions that limit ability to apply the treatment e.g., needing a health aide or caregiver to record sleep diaries, unable to get out of bed without assistance
- •Current pregnancy and/or birth of a child within the previous 6 months
- •Current alcohol or illicit substance use disorders or early remission (at least 3 months abstinent)
- •Active suicidal or homicidal ideation
- •A history of any bipolar disorder spectrum disorder or psychotic disorder
- •Hospitalization for a mental health disorder in the past 2 months
- •Enrolled in current PTSD-focused treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure), current nightmare treatment or a history of treatment failure with a cognitive-behavioral nightmare intervention
- •Veterans may also be excluded from participation if they have been identified by the local VA disruptive behavior committee to have displayed disruptive, threatening and/or violent behavior
研究组 & 干预措施
Exposure, Relaxation, and Rescripting Therapy (ERRT)
Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately one hour per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, sleep behavior modification, Progressive Muscle Relaxation, diaphragmatic breathing, exposure to the trauma-nightmare, rescription, and treatment maintenance planning.
干预措施: Exposure, Relaxation, and Rescripting Therapy (Behavioral)
Sleep and Nightmare Management
This treatment protocol has amounts of therapist contact, handouts, and homework between sessions equivalent to those in ERRT. The protocol contains psychoeducation about sleep disturbances and trauma-related nightmares, including their distressing nature, chronicity, and impact on sleep and daytime functioning. Additionally, basic sleep behavior modification are presented. No nightmare content or rescripting will be explicitly discussed, and the diaphragmatic breathing techniques will be omitted from this protocol.
干预措施: Sleep and Nightmare Management (Behavioral)
结局指标
主要结局
Change in Actigraphy-derived sleep efficiency (SE)
时间窗: Nightly up to 7 weeks (Baseline through 1-week post treatment assessment)
Mattress actigraphy will be continuously recorded during the study period. Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period. Lower sleep efficiency indicates worse sleep.
Change in Actigraphy-derived respiratory sinus arrhythmia (RSA)
时间窗: Nightly (Baseline until 1-week post treatment assessment; 7 weeks)
Mattress actigraphy will be continuously recorded during the study period. RSA is the high frequency powers of heart period variability (0.15-0.4 Hz). Lower RSA indicates more cardiac vagal withdrawal.
Change in Nightmare Frequency
时间窗: Baseline past week; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period
This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Nightly reports will be collected from daily sleep diaries and pushes to event markers during the night.
Actigraphy-derived Sleep Efficiency (SE) Percentage
时间窗: Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment
Sleep efficiency will be calculated per night from a mattress actigraphy system and averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Sleep efficiency is defined as the ratio of the aggregate duration of quiescent sleep periods divided by the duration of the total in bed period multiplied by 100 to convert sleep efficiency to percentage points. Lower sleep efficiency indicates more disrupted sleep.
Actigraphy-derived Respiratory Sinus Arrhythmia (RSA)
时间窗: Week from mattress installation to first treatment session; Week from last treatment session to 1-week post-5-week-treatment assessment
Respiratory sinus arrhythmia (RSA) was computed in the 0.15-0.40 Hz band, using median values from high-quality inter-beat-intervals segments, each night. These data were averaged for two time-periods (the week between mattress installation and the first treatment session; the week between the last treatment session to the 1-week post-5-week treatment assessment). Lower RSA indicates more cardiac vagal withdrawal.
Change in Nightmare Frequency
时间窗: Baseline past week; post-5-week-treatment past week; 3-month follow-up past week
This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following 5-week treatment, and three months following treatment).
次要结局
- Change in PTSD Symptom Severity(Baseline, 1-week post-treatment, 3-month follow-up)
- Change in Nightmare Severity(Baseline; Nightly during baseline; 1-week post-treatment; 3-month follow-up treatment period)
- Change in Total PTSD Symptom Severity(Baseline, 1-week post-5-week-treatment, 3-month follow-up)
- Change in Nightmare Severity(Baseline past week; post-5-week-treatment past week; 3-month follow-up past week)