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Given the high prevalence of post-traumatic stress disorder (PTSD) in veterans and active duty military, the focus of this research study is to test the reliability of two new PTSD assessments, the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) and compare the results between the two new assessments and the previous "gold standard", the Clinician Administered PTSD Scale for DSM-IV (CAPS-IV). Biomarkers believed to be related to PTSD (e.g., biofluid biomarkers, cognitive and physiological markers, and neural activity as measured by EEG) will be collected to inform targeted interventions in specific groups of patients and other large-scale biomarker discovery efforts in the field. Participants will be 950 male and female active duty military and veterans ages 18 or older who have been exposed to at least one traumatic event.
This is a randomized, observational study where participants will be randomized into one of the four study cohorts. The primary goals of this study are to establish the test-retest reliability of the CAPS-5 and the PSSI-5 and to compare these with each other (Cohorts 1 and 2), to test the convergent validity of the CAPS-5 against the PSSI (Cohort 3) and against the CAPS-IV (Cohort 4), and finally to investigate the consistency of response over 12 weeks on CAPS-5 (Cohort 1) and on the PSSI-5 (Cohort 2). In addition, on an exploratory level, possible biomarkers of PTSD and their relationship to each other and to diagnosis of PTSD will be evaluated.
Participants will be 950 males and females recruited from the Cincinnati VA Medical Center (Cincinnati, OH), Trauma Recovery Center, and Tripler Army Medical Center (Honolulu, HI).
the investigators anticipate that understanding the validity and reliability of the PSSI-5 and the CAPS-5 and the biomarkers related to PTSD will provide necessary information for care provided to active duty military and veterans suffering from PTSD. It will also directly inform trial designs and increase the likelihood of technical and regulatory success for new treatments for PTSD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Individuals randomized to Cohort 1 will be assigned to the CAPS-5 and will complete between two and seven research visits. Participants will be administered the CAPS-5 during visit 2, and then will be randomized a second time into groups 1-A and 1-B. Group 1-A will end participation after visit 2. Group 1-B will complete visits 3-7 and will be administered the CAPS-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples. |
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| Cohort 2 | Individuals randomized to Cohort 2 will be assigned to the PSSI-5 and will complete between two and seven research visits. Participants will be administered the PSSI-5 during visit 2, and then will be randomized a second time into groups 2-A and 2-B. Group 2-A will end participation after visit 2. Group 2-B will complete visits 3-7 and will be administered the PSSI-5 at each of these visits along with other measures of cognitive and behavioral functioning, and will provide biofluid samples. |
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| Cohort 3 | Individuals randomized to Cohort 3 will have three office visits and will complete the CAPS-5 and the PSSI-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples. |
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| Cohort 4 | Individuals randomized to Cohort 4 will have three office visits and will complete the CAPS-IV and the CAPS-5 in a counter-balanced order during visits 2 and 3, along with other measures of cognitive and behavioral functioning, and will provide biofluid samples. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAPS-5 | Diagnostic Test | Clinician Administered PTSD Scale for DMS-5 |
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| Measure | Description | Time Frame |
|---|---|---|
| Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score | Concordance of the Clinician Administered PTSD Scale Total Score of at 2 visits. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme) | 7 days (+/- 2) between measurements |
| Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score | To determine the test-retest reliability of Posttraumatic Stress Disorder Symptom Scale Interview-5 within Visits 2-3 for Groups 1-B and 2-B. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme) | 7 days (+/- 2) between measurements |
| Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV) | Correlation coefficient among the totals scores for 3 different PTSD symptom scales | Up to 39 days from the eligibility screen for Cohorts 1-4 |
| Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeks | Change in the DSM-5 Clinician Administered PTSD Scale item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme) | Up to 6 weeks for Group 1-B |
| Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeks | Change in PTSD Symptom Scale for DSM-5 Posttraumatic Stress Disorder Symptom Scale Interview item-level scores over 6 weeks. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme) |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance rate between diagnostic tests | To determine the concordance rate between diagnosis of PTSD using the CAPS-IV and CAPS-5, and the CAPS-5 and PSSI-5. The severity of diagnosed PTSD is determined by the total score. (minimum score of 0 = absent to a maximum score of 80 = extreme) | 7 days (+/- 2) between measurements |
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Inclusion Criteria:
Exclusion Criteria:
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Active duty military personnel and veterans who satisfy the enrollment criteria. Study participants will be active duty personnel or veterans with PTSD symptoms, who may or may not meet diagnostic criteria for PTSD, recruit from up to two military treatment facilities (MTFs) and one VA facility.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Savannah Noppert | Contact | 513-861-3100 | 313262 | savannah.noppert@va.gov |
| Derrell Anderson, MS | Contact | 513-861-3100 | 313309 | derrell.anderson@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen M Chard, PhD | Cincinnati VA Medical Center, University of Cincinnati | Principal Investigator |
| Brian Marx, PhD | National Center for PTSD at VA Boston Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tripler Army Medical Center | Recruiting | Honolulu | Hawaii | 96859 | United States |
Final data sets resulting from this study will be shared outside the study team in de-identified format only. Data will be shared with study collaborators from the following institutions: VA Boston healthcare System, Stanford University, Palo Alto VA Health Care System, Auburn University, and the University of Pennsylvania. Research proposals from other institutions will be reviewed by a group of experienced scientists who will judge each request for its scientific merit, its potential contribution to the understanding of the disease, and for the qualifications of the research team. All data will be identified by a code number.
Starting in March 2020
De-identified, anonymized databases will be shared electronically through the VA network and secure messaging. Only de-identified data will be made available outside the VA. The optional biofluid collection for future exploratory research will only be made available to investigators in a de-identified format with the permission of the sponsor, proper protocol approval, and human participants' protection in place.
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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Whole blood; saliva; PAXgene RNA; plasma; serum; buffy coat (optional)
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| PSSI-5 | Diagnostic Test | PTSD Symptom Scale Interview for DSM-5 |
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| CAPS-IV | Diagnostic Test | Clinician Administered PTSD Scale for DSM-IV |
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| Up to 6 weeks for Group 2-B |
| Cincinnati VA Medical Center - Trauma Recovery Center | Recruiting | Fort Thomas | Kentucky | 41075 | United States |
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| Walter Reed National Military Medical Center | Recruiting | Bethesda | Maryland | 20814 | United States |
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