PTSD
Conditions
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALAcceptance 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
Sponsors
Portland VA Medical Center
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Veterans who have been previously deployed and meet diagnostic criteria for PTSD. Prior traumatic experience(s) does not have to be direct combat (e.g. may include search and rescue of combat operations). Persons previously treated for PTSD will be eligible so long as current diagnostic criteria are present. Specific inclusion criteria are as follows: * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coherence | Pre-treatment (within one week of initiation of PTSD therapy), within one week before initiation of their treatment protocol, within one week after the conclusion of their treatment phase, and about three months after their last therapy session | Coherence describes the degree of electrical activity (EEG) synchrony among brain regions. Coherence is equivalent to correlation coefficient in frequency domain and takes values from 0 (no synchrony) to 1 (perfect synchrony). A detailed description of this method is provided in: Modarres M, Cochran D, Kennedy DN, Frazier JA. Comparison of comprehensive quantitative EEG metrics between typically developing boys and girls in resting state eyes-open and eyes-closed conditions. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Veterans With PTSD Undergoing Therapy PTSD undergoing therapy to be studies before and after treatment | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Veterans With PTSD Undergoing Therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 13.7 |
| Coherence | 0.28 Coherence STANDARD_DEVIATION 0.02 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
Primary
Coherence
Coherence describes the degree of electrical activity (EEG) synchrony among brain regions. Coherence is equivalent to correlation coefficient in frequency domain and takes values from 0 (no synchrony) to 1 (perfect synchrony). A detailed description of this method is provided in: Modarres M, Cochran D, Kennedy DN, Frazier JA. Comparison of comprehensive quantitative EEG metrics between typically developing boys and girls in resting state eyes-open and eyes-closed conditions.
Time frame: Pre-treatment (within one week of initiation of PTSD therapy), within one week before initiation of their treatment protocol, within one week after the conclusion of their treatment phase, and about three months after their last therapy session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PTSD Veterans Undergoing Psychotherap | Coherence | Baseline (Before Initiation of Therapy | 0.28 Coherence | Standard Deviation 0.02 |
| PTSD Veterans Undergoing Psychotherap | Coherence | End ot Therapy | 0.27 Coherence | Standard Deviation 0.02 |
| PTSD Veterans Undergoing Psychotherap | Coherence | 3-Month Follow-up | 0.27 Coherence | Standard Deviation 0.27 |
Comparison: Pair-wise comparison of changes in coherency from baseline (before therapy) to the end of therapy.~Pair-wise comparison of changes in coherency from end of therapy to 3-month follow-upp-value: 0.01Wilcoxon (Mann-Whitney)