Novel EEG Coherence Biomarkers for PTSD Assessment

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-12-31

Brief Summary

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Current practice for diagnosing and managing PTSD relies primarily on subjective clinical assessments by clinicians as well as patient self-report. An independent, objective and neuro-physiology based method for directly assessing brain function is not available, but is much needed to improve diagnosis and management of PTSD. To address this critical need, the investigators propose to test a set of novel biomarkers which are based on measures of coherent activity among the regions of cerebral cortex during sleep. In preliminary studies on EEG acquired during sleep from Veterans with PTSD alone as well as other co-morbidities, the investigators have shown that the neuromarkers were highly sensitive/specific to the presence of PTSD, and highly sensitive to the severity of symptoms in PTSD group. The overall goal of this project is to further validate these novel neurophysiology marker in retrospective and prospective studies

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Detailed Description

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This is a prospective study with PTSD (n=50) at multiple times during the Veterans ongoing clinical treatment for PTSD. Sleep EEG measures will be collected at pretreatment, after first session of therapy, immediately after completion of therapy, and at 3-month post therapy.

Methodology:

N=50 Veterans with PTSD symptoms undergoing the Veterans clinical treatment at the Bedford VA will be recruited and the following data will be acquired: Sleep-EEG, Demographic, Medical History, and Use of Medications forms, The Beck Depression Inventory, Pittsburgh Sleep Quality Index, Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form, NIH PROMIS, PCL-5, and Clinician-Administered PTSD Scale (CAPS-5). Primary independent variable will be changes in the Neuromarker and the dependent variables will consist of the functional and quality of life measures.

Conditions

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PTSD

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PTSD Undergoing Psycho-therapy

Veterans with PTSD seeking treatment and undergoing psycho-therapy

Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS)

Intervention Type BEHAVIORAL

ACT is an evidence-based treatment that focuses on identifying a person's valued life goals and explicitly targets experiential avoidance to assist clients in committing to behavior change aligned with their values and becoming more psychologically flexible

Interventions

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Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD ( ACT-SS)

ACT is an evidence-based treatment that focuses on identifying a person's valued life goals and explicitly targets experiential avoidance to assist clients in committing to behavior change aligned with their values and becoming more psychologically flexible

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Current (past month) diagnosis of PTSD as determined from the 30-item CAPS (score \>45).
* History of deployment and combat-related exposure stated as the principal reason for seeking treatment (based on self-report).
* Ability to read and speak English to complete surveys and participate in therapy.
* Explicit denial of suicidal or homicidal ideation or intent, which will be corroborated by reviewing the patient chart.

Exclusion Criteria

* Brain injury prohibiting speech, writing, and purposeful actions.
* Identified to have current suicidal or homicidal ideation (immediate referral to a crisis center/hospital).
* Major confounding psychiatric disorder; i.e. assessment indicates presence of:

* Major mental health disorder that involves psychosis
* Otherwise in the state of psychological crisis (appropriate referral to occur)
* Current or recent (within 1 month of study entry) DSM-5 substance use disorder
* Individuals who are taking either illicit or prescribed Rx that could interfere with EEG, including benzodiazepines and certain mood stabilizers (e.g., Lithium)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes