Stress Disorders, Post-TraumaticNCT04180930
An Evaluation of Two PTSD Assessments in an Active Duty and Military Veteran Sample
An observational study of Stress Disorders, Post-Traumatic, run by U.S. Army Medical Research and Development Command at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress Disorders, Post-Traumatic
- What is being tested?
- CAPS-5, PSSI-5 and CAPS-IV
- Type of treatment
- Injection or infusion
- How many people
- 950 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2019to 30 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Male or female active duty personnel or military veterans, 18 years of age or older
- Competent to give informed consent
- Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)
- Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
Who cannot join
- Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation/Homicidal Ideation screening tool (SI/HI screen)
- Assessment using CAPS or PSSI in the previous 1 year
- Currently receiving psychotherapy or counseling for PTSD
- Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
- Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
Nathalie Jimenez, 202-377-9687, nathalie.t.jimenez.ctr@health.mil
Treven C Pickett, PsyD
- Recruiting
Cincinnati VA Medical Center - Trauma Recovery Center
Fort Thomas, Kentucky, 41075
Savannah Noppert, MS, 513-861-3100 ext. 313262, savnnah.noppert@va.gov
Derrell Anderson, 513-861-3100 ext. 313309, derrell.anderson@va.gov
- Recruiting
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Catherine Uyehara, PhD, 808-433-7163, catherine.yamauchi2.civ@health.mil
Monique Weisman, LSW, 808-433-5067, monique.s.weisman.ctr@health.mil
About this study
Official title: Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample
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.
Read the detailed description
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.
- Conditions
- Stress Disorders, Post-Traumatic
- Being tested
- CAPS-5, PSSI-5, CAPS-IV
- Keywords
- Assessment, Post-Traumatic Stress Disorder, PTSD, Veterans, Military
- 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.
CAPS-5Diagnostic test
Clinician Administered PTSD Scale for DMS-5
PSSI-5Diagnostic test
PTSD Symptom Scale Interview for DSM-5
CAPS-IVDiagnostic test
Clinician Administered PTSD Scale for DSM-IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CAPS-5 | |
| 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. Receives: Diagnostic Test: PSSI-5 | |
| 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. Receives: Diagnostic Test: CAPS-5; Diagnostic Test: PSSI-5 | |
| 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. Receives: Diagnostic Test: CAPS-5; Diagnostic Test: CAPS-IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: Up to 6 weeks for Group 2-B
Secondary outcomes (1)
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)
Measured: 7 days (+/- 2) between measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start15 Apr 2019
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathleen M Chard, PhD, Principal investigator, Cincinnati VA Medical Center, University of CincinnatiBrian Marx, PhD, Principal investigator, National Center for PTSD at VA Boston Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180930
- Sponsor's protocol ID
- 2017-7745
- Status last verified
- Jan 2025
- First submitted
- 25 Jun 2019
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Evaluation of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Symptom Scale Interview for DSM-5 (PSSI-5) in an Active Duty and Military Veteran Sample
- ClinicalTrials.gov ID
- NCT04180930
- Acronym / sponsor ID
- 2017-7745
- Conditions
- Stress Disorders, Post-Traumatic
- Keywords
- Assessment, Post-Traumatic Stress Disorder, PTSD, Veterans, Military
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 29 Nov 2019 (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.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: CAPS-5Individuals 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. |
| Cohort 2 | – | Diagnostic Test: PSSI-5Individuals 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. |
| Cohort 3 | – | Diagnostic Test: CAPS-5, Diagnostic Test: PSSI-5Individuals 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. |
| Cohort 4 | – | Diagnostic Test: CAPS-5, Diagnostic Test: CAPS-IVIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- Male or female active duty personnel or military veterans, 18 years of age or older
- Competent to give informed consent
- Have experienced any Criterion A qualifying traumatic event as defined by the Life Events Checklist for DSM-5 (LEC-5)
- Score a 3 or above on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)
Key exclusion criteria (5 listed)
- Current suicidal or homicidal ideation with a plan, and substance use disorder requiring detoxification currently or in the past month as assessed using the SCID and Suicidal Ideation/Homicidal Ideation screening tool (SI/HI screen)
- Assessment using CAPS or PSSI in the previous 1 year
- Currently receiving psychotherapy or counseling for PTSD
- Moderate to sever cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)
- Meet criteria for unmedicated Bipolar I, Bipolar II, Schizophrenia, or other psychotic disorders in the last month
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 |
|---|---|---|
| CAPS-5Clinician Administered PTSD Scale for DMS-5 | Diagnostic test | Cohort 1, Cohort 3, Cohort 4 |
| PSSI-5PTSD Symptom Scale Interview for DSM-5 | Diagnostic test | Cohort 2, Cohort 3 |
| CAPS-IVClinician Administered PTSD Scale for DSM-IV | Diagnostic test | Cohort 4 |
Primary outcome
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score
Time frame: 7 days (+/- 2) between measurements
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)
Test-retest reliability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) Total Score
Time frame: 7 days (+/- 2) between measurements
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)
Correlation among the total scores of the CAPS-5, PSSI-5, and Clinician Administered PTSD Scale for DSM-IV (CAPS-IV)
Time frame: Up to 39 days from the eligibility screen for Cohorts 1-4
Correlation coefficient among the totals scores for 3 different PTSD symptom scales
Stability of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) item-level scores over 6 weeks
Time frame: Up to 6 weeks for Group 1-B
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)
Stability of PTSD Symptom Scale - Interview for DSM-5 (PSSI-5) item-level scores over 6 weeks
Time frame: Up to 6 weeks for Group 2-B
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)
1 secondary outcome
Concordance rate between diagnostic tests
Time frame: 7 days (+/- 2) between measurements
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 23 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Kathleen M Chard, PhD principal investigator
Cincinnati VA Medical Center, University of Cincinnati
Brian Marx, PhD principal investigator
National Center for PTSD at VA Boston Healthcare System
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Disorders, Post-Traumatic, run by U.S. Army Medical Research and Development Command at 3 sites 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Savannah Noppert (513-861-3100 ext. 313262, savannah.noppert@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test-Retest reliability of Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Total Score (time frame: 7 days (+/- 2) between measurements). The study lists 5 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 23 Jan 2025.