Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (E-3PTSD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699660
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : October 16, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Post-Traumatic Stress Disorder
Interventions Behavioral: CAPS/WHODAS
Behavioral: Nonstructured Interview
Enrollment 406
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Period Title: Overall Study
Started 190 216
Completed 176 208
Not Completed 14 8
Reason Not Completed
Lost to Follow-up             4             2
missing reports and recording failures             10             6
Arm/Group Title Arm 1 Arm 2 Total
Hide Arm/Group Description

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Total of all reporting groups
Overall Number of Baseline Participants 176 208 384
Hide Baseline Analysis Population Description
Veterans undergoing compensation and pension examination for PTSD
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 176 participants 208 participants 384 participants
60
(41 to 63)
59
(41 to 62)
59
(41 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 208 participants 384 participants
Female
6
   3.4%
13
   6.3%
19
   4.9%
Male
170
  96.6%
195
  93.8%
365
  95.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 208 participants 384 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
44
  25.0%
56
  26.9%
100
  26.0%
White
103
  58.5%
124
  59.6%
227
  59.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
29
  16.5%
28
  13.5%
57
  14.8%
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 208 participants 384 participants
Married 108 130 238
Single 28 35 63
Separated 32 37 69
Other/Missing 8 6 14
1.Primary Outcome
Title Completeness and Quality of PTSD Interview
Hide Description total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Time Frame Post-exam, same day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Overall Number of Participants Analyzed 176 208
Mean (Standard Deviation)
Unit of Measure: percentage of criteria PTSD assessment
completeness of diagnostic assessment 84.8  (17.3) 29.8  (24.4)
completeness of functional assessment 76.2  (24.4) 3.1  (7.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 2
Comments Our sample size calculation yielded 466 for a power of 0.80 to detect a 10% absolute difference in sensitivity and adjusted for intraclass correlation. The number of covariates in regression models was limited to ensure the effective sample size remained ten times greater than the degrees of freedom in the model.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments Comparison of CAPS/WHODAS vs Nonstructured Interview study arms: linear and logistic mixed effects regression with clinical examiner stratified by study group as a random effect and study group as a fixed effect.
Method Regression, Linear
Comments Covariates included experience, use of template,tests,reviewing records,age,education, study site,reviewer, and expert reviewer by group interaction.
2.Secondary Outcome
Title PTSD Diagnosis
Hide Description Number of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Time Frame Post-exam, same day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Overall Number of Participants Analyzed 176 208
Measure Type: Number
Unit of Measure: participants
Uanble to determine clinician PTSD+ diagnosis 49 110
Unable to determine PTSD- diagnosis 14 73
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Patient Satisfaction
Hide Description Mean score on satisfaction survey rating scale from 1 to 5 (higher)
Time Frame post-exam, same day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Overall Number of Participants Analyzed 176 208
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.69  (.44) 4.74  (.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >.05
Comments Descriptive statistics on mean and standard deviation.
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Resource Utilization
Hide Description time spent administering the exam
Time Frame same day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description:

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

Overall Number of Participants Analyzed 176 208
Mean (Standard Deviation)
Unit of Measure: minutes
216.6  (88.6) 157.2  (63.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1, Arm 2
Comments Estimates of the influence on total time and tests of statistical significance were derived from multilevel mixed-effects linear regression (xtmixed in Stata)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .012
Comments 0.05 level based on a two tailed test.
Method Regression, Linear
Comments Covariates included years of experience, use of template, use of tests, age, education, study site.
Method of Estimation Estimation Parameter Slope
Estimated Value 47.3
Parameter Dispersion
Type: Standard Error of the Mean
Value: 18.86
Estimation Comments [Not Specified]
Time Frame Day of disability examination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 Arm 2
Hide Arm/Group Description

PTSD interview using CAPS and WHODAS

Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview

Usual PTSD interview, without CAPS or WHODAS

Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID

All-Cause Mortality
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)   0/208 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 Arm 2
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)   0/208 (0.00%) 
Information external to interview such as psychological testing or charts were not available to the expert reviewers. Another limitation is that Veterans in our study did not undergo a concurrent, independent evaluation for assessment of PTSD.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theodore Speroff PhD
Organization: Veterans Affairs at TVHS
Phone: 615-636-9476
EMail: ted.speroff@va.gov
Publications of Results:
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.
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00699660     History of Changes
Other Study ID Numbers: SDR 06-331
First Submitted: June 12, 2008
First Posted: June 18, 2008
Results First Submitted: September 23, 2014
Results First Posted: October 16, 2014
Last Update Posted: August 16, 2018