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

NCT07766798 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-17

No results posted yet for this study

Summary

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.

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Interventions

BEHAVIORAL

Written Exposure Therapy

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

BEHAVIORAL

Neutral Writing Condition

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

Sponsors & Collaborators

  • Mclean Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2031-07-30
Completion
2031-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07766798 on ClinicalTrials.gov