Trauma Recovery Via EEG and Actigraphy Tracking (TREAT): Biomarkers of Written Exposure Therapy in PTSD
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score
研究概览
简要总结
Posttraumatic stress disorder, or PTSD, can affect emotional health, sleep, daily functioning, and quality of life. Written Exposure Therapy is a brief trauma-focused psychotherapy in which participants complete structured writing exercises about a traumatic experience. However, it is not yet clear which changes in brain activity and sleep occur over the course of treatment or whether these measures can help predict who is most likely to benefit.
This study will enroll approximately 200 adults with PTSD. Participants will be randomly assigned to either Written Exposure Therapy or a neutral writing condition and will complete five weekly writing sessions. The study will collect electroencephalography, or EEG, recordings and actigraphy-based sleep and activity measures at scheduled time points before treatment, during the five-week intervention period, and after treatment. Participants will also complete clinical assessments of PTSD symptoms and related outcomes.
The primary goals are to identify EEG and sleep-related biomarkers associated with improvement in PTSD symptoms, determine how early these biomarkers change during treatment, and evaluate whether baseline measures can help predict individual treatment response.
详细描述
This randomized interventional study will examine neurophysiological and behavioral biomarkers of response to Written Exposure Therapy in adults with PTSD. Approximately 200 participants will be randomly assigned to Written Exposure Therapy or a neutral writing condition. Both conditions will involve five weekly writing sessions.
Participants will undergo repeated EEG assessments to measure brain activity and actigraphy monitoring to characterize sleep and daily activity. These assessments will occur at scheduled time points before treatment, during the five-week intervention period, and after treatment. Clinical assessments will include repeated measures of PTSD symptoms throughout the study and clinician-administered assessments before and after the intervention.
The study has three main objectives. First, it will evaluate changes in EEG and sleep measures from before to after the intervention and determine whether those changes are associated with improvement in PTSD symptoms. Second, it will examine weekly changes to identify the earliest point at which neurophysiological or sleep-related changes can be detected. Third, it will test whether baseline EEG, sleep, and clinical characteristics can predict treatment response and identify subgroups of participants with distinct response patterns.
The study is intended to improve understanding of the biological and behavioral mechanisms associated with Written Exposure Therapy and support the future development of personalized approaches to PTSD treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Clinician-administered outcome assessments will be conducted by assessors who are masked to participants' assigned study condition. Participants and intervention staff will be instructed not to disclose treatment assignment to the outcome assessors.
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
- •Age between 18 and 65
- •History of trauma, with current elevated PTSD symptoms
- •Ability to understand and sign informed consent
- •Ability to read and write in English
- •Stable psychotropic medications for at least six weeks prior to enrollment
排除标准
- •Metal in the head/neck
- •Current unstable medical conditions
- •Head injury with prolonged loss of consciousness (over 30 minutes) within the past 10 years
- •History of major neurological illness
- •History of seizures
- •History of central nervous system (CNS) tumors
- •History of stroke
- •History of cerebral aneurysm
- •Currently receiving trauma-focused therapy
- •Current benzodiazepine use
- •Currently receiving non-pharmacological treatment e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)
- •Current moderate or severe substance use disorder
- •Lifetime Bipolar I or primary psychotic illness
研究组 & 干预措施
Written Exposure Therapy
Participants assigned to this arm will complete five weekly Written Exposure Therapy sessions. In each session, participants will complete structured writing exercises focused on a traumatic experience. EEG, actigraphy, and clinical assessments will be collected at scheduled time points before treatment, during the five-week intervention period, and after treatment.
干预措施: Written Exposure Therapy (Behavioral)
Neutral Writing Condition
Participants assigned to this arm will complete five weekly neutral writing sessions that do not involve trauma-focused exposure. EEG, actigraphy, and clinical assessments will be collected at scheduled time points before the intervention, during the five-week intervention period, and after the intervention.
干预措施: Neutral Writing Condition (Behavioral)
结局指标
主要结局
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score
时间窗: Baseline (Week 0) and post-intervention at Week 6
Posttraumatic stress disorder symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The total severity score ranges from 0 to 80, with higher scores indicating greater symptom severity. Change from baseline to post-intervention will be evaluated and compared between the Written Exposure Therapy and neutral writing conditions.
Change in PTSD Checklist for DSM-5 Total Score
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Posttraumatic stress disorder symptom severity will be assessed using the 20-item PTSD Checklist for DSM-5 (PCL-5). Total scores range from 0 to 80, with higher scores indicating greater symptom severity. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Delta Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG delta relative power will be quantified in the prespecified delta frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Theta Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG theta relative power will be quantified in the prespecified theta frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Alpha Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG alpha relative power will be quantified in the prespecified alpha frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Beta Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG beta relative power will be quantified in the prespecified beta frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Slow Gamma Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG slow gamma relative power will be quantified in the prespecified slow gamma frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Fast Gamma Relative Power
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG fast gamma relative power will be quantified in the prespecified fast gamma frequency band and reported as a percentage of total spectral power. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Functional Connectivity
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG functional connectivity will be quantified using Pearson correlation across channels. Functional connectivity values will be reported as dimensionless connectivity coefficients. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Shannon Entropy
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG Shannon entropy will be quantified from the EEG time series and reported as a dimensionless value. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Rényi Entropy
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG Rényi entropy will be quantified from the EEG time series and reported as a dimensionless value. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Hjorth Mobility
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG Hjorth mobility will be quantified from the EEG time series and reported as a dimensionless value. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Resting-State EEG Hjorth Activity
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Resting-state EEG Hjorth activity will be quantified from the EEG time series. Hjorth activity reflects the variance of the EEG signal and will be reported in squared signal-amplitude units. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Total Sleep Time
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Total sleep time will be estimated from wrist actigraphy and reported in minutes per night. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Sleep Efficiency
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Sleep efficiency will be estimated from wrist actigraphy and reported as the percentage of time in bed spent asleep. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Wake After Sleep Onset
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Wake after sleep onset will be estimated from wrist actigraphy and reported in minutes per night. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Sleep Onset Latency
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Sleep onset latency will be estimated from wrist actigraphy and reported in minutes. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Sleep Fragmentation
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Sleep fragmentation will be estimated from wrist actigraphy and reported as a sleep fragmentation index (dimensionless). Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Approximate Entropy
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Approximate entropy of actigraphy-derived sleep activity will be calculated from wrist actigraphy and reported as a dimensionless value. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
Change in Actigraphy-Derived Sample Entropy
时间窗: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Sample entropy of actigraphy-derived sleep activity will be calculated from wrist actigraphy and reported as a dimensionless value. Change from baseline will be evaluated across study visits and compared between the Written Exposure Therapy and neutral writing conditions.
次要结局
未报告次要终点
研究者
Mohammad Sendi, PhD
Assistant Neuroscientist
Mclean Hospital