Posttraumatic Stress Disorder (PTSD)TREATNCT07766798
EEG and Actigraphy Biomarkers of Written Exposure Therapy for Posttraumatic Stress Disorder
A study testing Written Exposure Therapy and Neutral Writing Condition in people with Posttraumatic Stress Disorder (PTSD), run by Mclean Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- Written Exposure Therapy and Neutral Writing Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Stable psychotropic medications for at least six weeks prior to enrollment
Who cannot join
- 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
- History of seizures
- History of central nervous system (CNS) tumors
Show all 14Show fewer
- History of stroke
- History of cerebral aneurysm
- Currently receiving trauma-focused therapy
- Current benzodiazepine use
- Currently receiving non-pharmacological treatment e.g. transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)
- Current moderate or severe substance use disorder
- Lifetime Bipolar I or primary psychotic illness
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Trauma Recovery Via EEG and Actigraphy Tracking (TREAT): Biomarkers of Written Exposure Therapy in PTSD
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- Written Exposure Therapy, Neutral Writing Condition
- Keywords
- Written Exposure Therapy, Electroencephalography, Actigraphy, Treatment Response, Biomarkers
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written Exposure TherapyBehavioural
Written Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience.
Neutral Writing ConditionBehavioural
The neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure.
| Study group | Role | What they receive |
|---|---|---|
| Written Exposure Therapy | Experimental | 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. Receives: Behavioral: Written Exposure Therapy |
| Neutral Writing Condition | Active comparator | 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. Receives: Behavioral: Neutral Writing Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) and post-intervention at Week 6
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Alpha Relative Power
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Beta Relative Power
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Slow Gamma Relative Power
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Fast Gamma Relative Power
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Functional Connectivity
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Shannon Entropy
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Rényi Entropy
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Hjorth Mobility
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Resting-State EEG Hjorth Activity
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Total Sleep Time
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Efficiency
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Wake After Sleep Onset
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Onset Latency
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sleep Fragmentation
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Approximate Entropy
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Change in Actigraphy-Derived Sample Entropy
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.
Measured: Baseline (Week 0), treatment Weeks 1, 2, 3, 4, and 5, and post-intervention at Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jul 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sendi, PhD, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766798
- Sponsor's protocol ID
- 2026P001981
- Acronym
- TREAT
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared through the National Institute of Mental Health (NIMH) Data Archive (NDA) in accordance with participant consent, institutional requirements, and applicable National Institutes of Health (NIH) data-sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Recovery Via EEG and Actigraphy Tracking (TREAT): Biomarkers of Written Exposure Therapy in PTSD
- ClinicalTrials.gov ID
- NCT07766798
- Acronym / sponsor ID
- TREAT / 2026P001981
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- Written Exposure Therapy, Electroencephalography, Actigraphy, Treatment Response, Biomarkers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jul 2031 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Written Exposure Therapy | Experimental | Behavioral: Written Exposure TherapyParticipants 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. |
| Neutral Writing Condition | Active comparator | Behavioral: Neutral Writing ConditionParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Stable psychotropic medications for at least six weeks prior to enrollment
Key exclusion criteria (14 listed)
- 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
- History of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written Exposure TherapyWritten Exposure Therapy consists of five weekly sessions in which participants complete structured writing exercises focused on a traumatic experience. | Behavioural | Written Exposure Therapy |
| Neutral Writing ConditionThe neutral writing condition consists of five weekly sessions in which participants complete structured writing exercises that do not involve trauma-focused exposure. | Behavioural | Neutral Writing Condition |
Primary outcome
Change in Clinician-Administered PTSD Scale for DSM-5 Total Severity Score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Change in Resting-State EEG Alpha Relative Power
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared through the National Institute of Mental Health (NIMH) Data Archive (NDA) in accordance with participant consent, institutional requirements, and applicable National Institutes of Health (NIH) data-sharing policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Written Exposure Therapy and Neutral Writing Condition in people with Posttraumatic Stress Disorder (PTSD), run by Mclean Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Sendi, PhD (617-855-4236, msendi@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.