Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00699660
Other study ID # SDR 06-331
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 2009
Est. completion date September 2011

Study information

Verified date July 2018
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project evaluated the impact of semi-structured, standardized interviews on the initial PTSD C&P on the examination.


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.


Recruitment information / eligibility

Status Completed
Enrollment 406
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

1. Veterans referred to VHA for an Initial PTSD Compensation and Pension Examination

2. Informed consent

Exclusion Criteria:

1. Mentally impaired, not able to give informed consent

2. English speaking

Study Design


Intervention

Behavioral:
CAPS/WHODAS
CAPS/WHODAS structured clinical PTSD interview
Nonstructured Interview
Usual PTSD clinical PTSD interview, not CAPS or SCID

Locations

Country Name City State
United States New Mexico VA Health Care System, Albuquerque, NM Albuquerque New Mexico
United States VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA Boston Massachusetts
United States John D. Dingell VA Medical Center, Detroit, MI Detroit Michigan
United States Memphis VA Medical Center, Memphis, TN Memphis Tennessee
United States Clement J. Zablocki VA Medical Center, Milwaukee, WI Milwaukee Wisconsin
United States Minneapolis VA Health Care System, Minneapolis, MN Minneapolis Minnesota
United States Tennessee Valley Healthcare System Nashville Campus, Nashville, TN Nashville Tennessee
United States Southeast Louisiana Veterans Health Care System, New Orleans, LA New Orleans Louisiana
United States Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR North Little Rock Arkansas
United States VA Palo Alto Health Care System, Palo Alto, CA Palo Alto California
United States VA Connecticut Healthcare System West Haven Campus, West Haven, CT West Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 Str — View Citation

Marx 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.

Marx 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. — View Citation

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. — View Citation

Rosen 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: — View Citation

Sloan 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. — View Citation

Speroff 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 f — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Completeness and Quality of PTSD Interview total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment Post-exam, same day
Secondary 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). Post-exam, same day
Secondary Patient Satisfaction Mean score on satisfaction survey rating scale from 1 to 5 (higher) post-exam, same day
Secondary Resource Utilization time spent administering the exam same day
See also
  Status Clinical Trial Phase
Recruiting NCT04317820 - Deep Brain Reorienting in Post-traumatic Stress Disorder N/A
Completed NCT05112003 - Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot N/A
Recruiting NCT04518267 - Anger and Psychotrauma: Data From Military and Civilians
Completed NCT02502604 - Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder N/A
Terminated NCT02234687 - A mGlu2/3 Agonist in the Treatment of PTSD Phase 1
Completed NCT02256566 - Cognitive Training for Mood and Anxiety Disorders N/A
Completed NCT01738308 - The Effects of Healing Touch on Post Operative Pediatric Patients N/A
Terminated NCT02520726 - PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims Phase 4
Completed NCT02213900 - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy Phase 4
Completed NCT01437891 - Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF) N/A
Completed NCT01517711 - Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD) Phase 4
Completed NCT01199107 - Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD) Phase 3
Completed NCT01998100 - Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD) Phase 3
Completed NCT01231711 - Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention Phase 1
Completed NCT00680524 - Telephone-based Care for OEF/OIF Veterans With PTSD N/A
Completed NCT00838006 - Psychophysiologic Predictors of Post-deployment Mental Health Outcomes N/A
Completed NCT00348036 - Group Intervention for Interpersonal Trauma N/A
Completed NCT00525226 - Evaluating the Effects of Stress in Pregnancy N/A
Completed NCT00158262 - Effect of Propranolol on Preventing Posttraumatic Stress Disorder Phase 4
Completed NCT00183690 - Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents Phase 1