Trial Outcomes & Findings for Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment (NCT NCT00699660)
NCT ID: NCT00699660
Last Updated: 2018-08-16
Results Overview
total completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
406 participants
Primary outcome timeframe
Post-exam, same day
Results posted on
2018-08-16
Participant Flow
Participant milestones
| Measure |
Arm 1
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
216
|
|
Overall Study
COMPLETED
|
176
|
208
|
|
Overall Study
NOT COMPLETED
|
14
|
8
|
Reasons for withdrawal
| Measure |
Arm 1
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
2
|
|
Overall Study
missing reports and recording failures
|
10
|
6
|
Baseline Characteristics
Enhancing Equitable and Effective (E-3) Post Traumatic Stress Disorder (PTSD) Disability Assessment
Baseline characteristics by cohort
| Measure |
Arm 1
n=176 Participants
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
n=208 Participants
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
Total
n=384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
59 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
170 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
365 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
103 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Marital Status
Married
|
108 participants
n=5 Participants
|
130 participants
n=7 Participants
|
238 participants
n=5 Participants
|
|
Marital Status
Single
|
28 participants
n=5 Participants
|
35 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Marital Status
Separated
|
32 participants
n=5 Participants
|
37 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Marital Status
Other/Missing
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-exam, same daytotal completeness of diagnostic assessment score, range from 0 to 100% and completeness of functional assessment
Outcome measures
| Measure |
Arm 1
n=176 Participants
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
n=208 Participants
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
Completeness and Quality of PTSD Interview
completeness of diagnostic assessment
|
84.8 percentage of criteria PTSD assessment
Standard Deviation 17.3
|
29.8 percentage of criteria PTSD assessment
Standard Deviation 24.4
|
|
Completeness and Quality of PTSD Interview
completeness of functional assessment
|
76.2 percentage of criteria PTSD assessment
Standard Deviation 24.4
|
3.1 percentage of criteria PTSD assessment
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: Post-exam, same dayNumber of participants who were unable to receive a conclusive clinician PTSD diagnosis for positive or negative PTSD symptoms (unable to determine clinician diagnosis).
Outcome measures
| Measure |
Arm 1
n=176 Participants
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
n=208 Participants
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
PTSD Diagnosis
Uanble to determine clinician PTSD+ diagnosis
|
49 participants
|
110 participants
|
|
PTSD Diagnosis
Unable to determine PTSD- diagnosis
|
14 participants
|
73 participants
|
SECONDARY outcome
Timeframe: post-exam, same dayMean score on satisfaction survey rating scale from 1 to 5 (higher)
Outcome measures
| Measure |
Arm 1
n=176 Participants
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
n=208 Participants
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
Patient Satisfaction
|
4.69 units on a scale
Standard Deviation .44
|
4.74 units on a scale
Standard Deviation .38
|
SECONDARY outcome
Timeframe: same daytime spent administering the exam
Outcome measures
| Measure |
Arm 1
n=176 Participants
PTSD interview using CAPS and WHODAS
Clinician Assessment of PTSD Symptoms (CAPS): CAPS/WHODAS structured clinical PTSD interview
|
Arm 2
n=208 Participants
Usual PTSD interview, without CAPS or WHODAS
Nonstructured Interview: Usual PTSD clinical PTSD interview, not CAPS or SCID
|
|---|---|---|
|
Resource Utilization
|
216.6 minutes
Standard Deviation 88.6
|
157.2 minutes
Standard Deviation 63.8
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place