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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
200
Written Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.
The neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure.
Oaks Building
Belmont, Massachusetts, United States
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score
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.
Time frame: Baseline (Week 0) and post-intervention at Week 6
Change in PTSD Checklist for DSM-5 Total Score
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Delta Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Theta Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Alpha Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Beta Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Slow Gamma Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Fast Gamma Relative Power
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Functional Connectivity
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Shannon Entropy
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Rényi Entropy
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Hjorth Mobility
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Hjorth Activity
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Total Sleep Time
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Efficiency
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Wake After Sleep Onset
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Onset Latency
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Fragmentation
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Approximate Entropy
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sample Entropy
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.
Time frame: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
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