About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Written Exposure Therapy
BehavioralWritten Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.
Neutral Writing Condition
BehavioralThe neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure.
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
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