Post-Traumatic Stress DisorderE-3PTSDNCT00699660
Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment
A study testing CAPS/WHODAS and Nonstructured Interview in people with Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 11 sites in United States.
Trial summary
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- CAPS/WHODAS and Nonstructured Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
- Informed consent
Who cannot join
- Mentally impaired, not able to give informed consent
- English speaking
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, 87108-5153
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201
Memphis VA Medical Center, Memphis, TN
Memphis, Tennessee, 38104
Clement J. Zablocki VA Medical Center, Milwaukee, WI
Milwaukee, Wisconsin, 53295-1000
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
Nashville, Tennessee, 37212-2637
Southeast Louisiana Veterans Health Care System, New Orleans, LA
New Orleans, Louisiana, 70112
Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
North Little Rock, Arkansas, 72114-1706
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516
About this study
Official title: Enhancing Equitable and Effective PTSD Disability Assessment
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination.
Read the detailed description
Our objective is to compare the process and outcomes of C\&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C\&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C\&P examination process, 2) develop research tools, instruments and methods for C\&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C\&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- CAPS/WHODAS, Nonstructured Interview
- Keywords
- Disability Examination, Clinician Administered PTSD Scale, Quality of Care
- 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/WHODASBehavioural
CAPS/WHODAS structured clinical PTSD interview
Nonstructured InterviewBehavioural
Also called Usual Clinical Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID
| Study group | Role | What they receive |
|---|---|---|
| CAPS/WHODAS | Experimental | PTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview Receives: Behavioral: CAPS/WHODAS |
| Nonstructured Interview | Active comparator | Usual clinical interview to assess PTSD, without CAPS or WHODAS Receives: Behavioral: Nonstructured Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness and Quality of PTSD Interview
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Measured: Post-exam, same day
Secondary outcomes (3)
PTSD Diagnosis
Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Measured: Post-exam, same day
Patient Satisfaction
Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Measured: post-exam, same day
Resource Utilization
time spent administering the exam
Measured: same day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startMay 2009
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Theodore Speroff, PhD, Principal investigator, Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699660
- Sponsor's protocol ID
- SDR 06-331
- Acronym
- E-3PTSD
- Status last verified
- Jul 2018
- First submitted
- 12 Jun 2008
- Last updated
- 16 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Rosen MI, Afshartous D, Marx BP. Did microinsults and microaggressions play a role?: in reply. Psychiatr Serv. 2013 Jul 1;64(7):713. doi: 10.1176/appi.ps.640703. No abstract available.
PubMed 23821175Rosen MI, Afshartous DR, Nwosu S, Scott MC, Jackson JC, Marx BP, Murdoch M, Sinnott PL, Speroff T. Racial differences in veterans' satisfaction with examination of disability from posttraumatic stress disorder. Psychiatr Serv. 2013 Apr 1;64(4):354-9. doi: 10.1176/appi.ps.201100526.
PubMed 23318842Speroff T, Sinnott PL, Marx B, Owen RR, Jackson JC, Greevy R, Sayer N, Murdoch M, Shane AC, Smith J, Alvarez J, Nwosu SK, Keane T, Weathers F, Schnurr PP, Friedman MJ. Impact of evidence-based standardized assessment on the disability clinical interview for diagnosis of service-connected PTSD: a cluster-randomized trial. J Trauma Stress. 2012 Dec;25(6):607-15. doi: 10.1002/jts.21759.
PubMed 23225029Marx BP, Jackson JC, Schnuff PP, Murdoch M, Sayer NA, Keane TM, Friedman MJ, Greevy RA, Owen RR, Sinnott PL, Speroff T. The reality of malingered PTSD among Veterans: Reply to McNally and Frueh. Journal of traumatic stress. 2012 Aug 1; 25(4):457-60.
Jackson JC, Sinnott PL, Marx BP, Murdoch M, Sayer NA, Alvarez JM, Greevy RA, Schnurr PP, Friedman MJ, Shane AC, Owen RR, Keane TM, Speroff T. Variation in practices and attitudes of clinicians assessing PTSD-related disability among veterans. J Trauma Stress. 2011 Oct;24(5):609-13. doi: 10.1002/jts.20688. Epub 2011 Sep 12.
PubMed 21913226Marx BP, Marshall PJ, Castro F. The moderating effects of stimulus valence and arousal on memory suppression. Emotion. 2008 Apr;8(2):199-207. doi: 10.1037/1528-3542.8.2.199.
PubMed 18410194Sloan DM, Marx BP, Epstein EM, Dobbs JL. Expressive writing buffers against maladaptive rumination. Emotion. 2008 Apr;8(2):302-6. doi: 10.1037/1528-3542.8.2.302.
PubMed 18410204
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Equitable and Effective PTSD Disability Assessment
- ClinicalTrials.gov ID
- NCT00699660
- Acronym / sponsor ID
- E-3PTSD / SDR 06-331
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Disability Examination, Clinician Administered PTSD Scale, Quality of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- May 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 18 Jun 2008 (estimated)
- Results
- Posted 16 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C\&P on the examination.
Detailed description
Our objective is to compare the process and outcomes of C\&P exams for PTSD conducted with CAPS and WHODAS-II interviews versus the PTSD exams conducted without the CAPS and WHODAS-II interviews. This project will conduct a randomized controlled trial on 688 veterans to evaluate the effects of the CAPS/WHODAS instruments on the initial PTSD C\&P examination process. Study outcomes include variation in assessing the DSM-IV components of PTSD, diagnostic accuracy, veteran perception of the exam process, VBA rater utility and resource utilization. This project will 1) demonstrate the feasibility of conducting program evaluation and intervention studies on the PTSD C\&P examination process, 2) develop research tools, instruments and methods for C\&P evaluation, 3) provide data on the value-added contribution of CAPS and WHODAS-II to the PTSD assessment process and examination report, and 4) inform the business case of utilizing the CAPS and WHODAS-II in the PTSD C\&P process. The ultimate aim is to improve the reproducibility, consistency and validity of the PTSD examination process while maintaining a level of efficiency and cost restraint that provides veterans with an exam process that is fair, accurate and equitable across VHA.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPS/WHODAS | Experimental | Behavioral: CAPS/WHODASPTSD assessed using Clinical Assessment of PTSD Symptoms (CAPS) and WHODAS functional impairment structured evidence-based interview |
| Nonstructured Interview | Active comparator | Behavioral: Nonstructured InterviewUsual clinical interview to assess PTSD, without CAPS or WHODAS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination
- Informed consent
Key exclusion criteria (2 listed)
- Mentally impaired, not able to give informed consent
- English speaking
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/WHODASCAPS/WHODAS structured clinical PTSD interview | Behavioural | CAPS/WHODAS |
| Nonstructured InterviewAlso: Usual Clinical InterviewUsual PTSD clinical PTSD interview, not CAPS or SCID | Behavioural | Nonstructured Interview |
Primary outcome
Completeness and Quality of PTSD Interview
Time frame: Post-exam, same day
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
3 secondary outcomes
PTSD Diagnosis
Time frame: Post-exam, same day
Patient Satisfaction
Time frame: post-exam, same day
Resource Utilization
Time frame: same day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23821175Rosen MI, Afshartous D, Marx BP. Did microinsults and microaggressions play a role?: in reply. Psychiatr Serv. 2013 Jul 1;64(7):713. doi: 10.1176/appi.ps.640703. No abstract available.
- Results publication: PubMed 23318842Rosen MI, Afshartous DR, Nwosu S, Scott MC, Jackson JC, Marx BP, Murdoch M, Sinnott PL, Speroff T. Racial differences in veterans' satisfaction with examination of disability from posttraumatic stress disorder. Psychiatr Serv. 2013 Apr 1;64(4):354-9. doi: 10.1176/appi.ps.201100526.
- Results publication: PubMed 23225029Speroff T, Sinnott PL, Marx B, Owen RR, Jackson JC, Greevy R, Sayer N, Murdoch M, Shane AC, Smith J, Alvarez J, Nwosu SK, Keane T, Weathers F, Schnurr PP, Friedman MJ. Impact of evidence-based standardized assessment on the disability clinical interview for diagnosis of service-connected PTSD: a cluster-randomized trial. J Trauma Stress. 2012 Dec;25(6):607-15. doi: 10.1002/jts.21759.
- Results publicationMarx BP, Jackson JC, Schnuff PP, Murdoch M, Sayer NA, Keane TM, Friedman MJ, Greevy RA, Owen RR, Sinnott PL, Speroff T. The reality of malingered PTSD among Veterans: Reply to McNally and Frueh. Journal of traumatic stress. 2012 Aug 1; 25(4):457-60.
- Results publication: PubMed 21913226Jackson JC, Sinnott PL, Marx BP, Murdoch M, Sayer NA, Alvarez JM, Greevy RA, Schnurr PP, Friedman MJ, Shane AC, Owen RR, Keane TM, Speroff T. Variation in practices and attitudes of clinicians assessing PTSD-related disability among veterans. J Trauma Stress. 2011 Oct;24(5):609-13. doi: 10.1002/jts.20688. Epub 2011 Sep 12.
- Results publication: PubMed 18410194Marx BP, Marshall PJ, Castro F. The moderating effects of stimulus valence and arousal on memory suppression. Emotion. 2008 Apr;8(2):199-207. doi: 10.1037/1528-3542.8.2.199.
- Results publication: PubMed 18410204Sloan DM, Marx BP, Epstein EM, Dobbs JL. Expressive writing buffers against maladaptive rumination. Emotion. 2008 Apr;8(2):302-6. doi: 10.1037/1528-3542.8.2.302.
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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. This study is not recruiting at the moment.
Theodore Speroff, PhD principal investigator
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPS/WHODAS and Nonstructured Interview in people with Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 11 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
Yes. Results are posted in the registry (first posted 16 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completeness and Quality of PTSD Interview (time frame: Post-exam, same day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699660, which also lists 7 linked publications.
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 16 Aug 2018.