EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMclean Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Written Exposure Therapy

    Behavioral

    Written Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.

  • Neutral Writing Condition

    Behavioral

    The neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Written Exposure TherapyExperimental treatment 1 intervention
Group B: Neutral Writing ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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