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

Part of paid clinical trials in Belmont, Massachusetts.

Sponsor
Mclean Hospital
Study ID
NCT07766798
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Posttraumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

First listed
Aug 17, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Jul 30, 2031
Completion
Sep 30, 2031

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score [ Time Frame: Baseline (Week 0) and post-intervention at Week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Oaks BuildingBelmontMassachusetts02478-

Find similar trials in Belmont, MA

By research site
Oaks Building· Belmont, MA

Related Studies