Posttraumatic Stress Disorder (PTSD)
Conditions
Keywords
Written Exposure Therapy, Electroencephalography, Actigraphy, Treatment Response, Biomarkers
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALWritten Exposure Therapy
Written Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.
BEHAVIORALNeutral 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
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinician-administered outcome assessments will be conducted by assessors who are masked to participants' assigned study condition. Participants and intervention staff will be instructed not to disclose treatment assignment to the outcome assessors.
Intervention model description
Participants will be randomly assigned in parallel to either Written Exposure Therapy or a neutral writing condition. Both groups will complete five weekly writing sessions and undergo EEG, actigraphy, and clinical assessments at scheduled time points before treatment, during the five-week intervention period, and after treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 65 2. History of trauma, with current elevated PTSD symptoms 3. Ability to understand and sign informed consent 4. Ability to read and write in English 5. Stable psychotropic medications for at least six weeks prior to enrollment
Exclusion criteria
1. Metal in the head/neck 2. Current unstable medical conditions 3. Head injury with prolonged loss of consciousness (over 30 minutes) within the past 10 years 4. History of major neurological illness 5. History of seizures 6. History of central nervous system (CNS) tumors 7. History of stroke 8. History of cerebral aneurysm 9. Currently receiving trauma-focused therapy 10. Current benzodiazepine use 11. Currently receiving non-pharmacological treatment e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT) 12. Current moderate or severe substance use disorder 13. Lifetime Bipolar I or primary psychotic illness 14. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Resting-State EEG Alpha Relative Power | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Beta Relative Power | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Slow Gamma Relative Power | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Fast Gamma Relative Power | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Functional Connectivity | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Shannon Entropy | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Rényi Entropy | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Hjorth Mobility | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Resting-State EEG Hjorth Activity | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Total Sleep Time | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Sleep Efficiency | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Wake After Sleep Onset | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Sleep Onset Latency | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Sleep Fragmentation | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Approximate Entropy | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Actigraphy-Derived Sample Entropy | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
| Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score | Baseline (Week 0) and post-intervention at Week 6 | 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 | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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 | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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 | Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6 | 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. |
Countries
United States
Contacts
CONTACTMohammad Sendi, PhD
Outcome results
None listed