Trial Outcomes & Findings for Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder (NCT NCT00539279)
NCT ID: NCT00539279
Last Updated: 2015-08-19
Results Overview
The PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.
COMPLETED
NA
87 participants
Pre-treatment, post-treatment, and 6-month follow-up
2015-08-19
Participant Flow
Participant milestones
| Measure |
Prolonged Exposure Therapy (PE)
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Treatment
STARTED
|
41
|
46
|
|
Treatment
COMPLETED
|
30
|
38
|
|
Treatment
NOT COMPLETED
|
11
|
8
|
|
Post-Treatment Assessment
STARTED
|
30
|
38
|
|
Post-Treatment Assessment
COMPLETED
|
18
|
29
|
|
Post-Treatment Assessment
NOT COMPLETED
|
12
|
9
|
|
6-Month Follow-Up Assessment
STARTED
|
18
|
29
|
|
6-Month Follow-Up Assessment
COMPLETED
|
17
|
22
|
|
6-Month Follow-Up Assessment
NOT COMPLETED
|
1
|
7
|
Reasons for withdrawal
| Measure |
Prolonged Exposure Therapy (PE)
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Treatment
Withdrawal by Subject
|
10
|
8
|
|
Treatment
Death
|
1
|
0
|
|
Post-Treatment Assessment
Lost to Follow-up
|
12
|
9
|
|
6-Month Follow-Up Assessment
Lost to Follow-up
|
1
|
7
|
Baseline Characteristics
Treatment of Older Veterans With Chronic Posttraumatic Stress Disorder
Baseline characteristics by cohort
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.51 Years
STANDARD_DEVIATION 6.21 • n=5 Participants
|
64.44 Years
STANDARD_DEVIATION 4.49 • n=7 Participants
|
65.54 Years
STANDARD_DEVIATION 5.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
69 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
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=5 Participants
|
46 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
PTSD Checklist (PCL)
|
57.46 units on a scale
STANDARD_DEVIATION 12.66 • n=5 Participants
|
59.98 units on a scale
STANDARD_DEVIATION 11.80 • n=7 Participants
|
58.28 units on a scale
STANDARD_DEVIATION 12.36 • n=5 Participants
|
|
Patient Health Questionnaire Depression Subscale (PHQ-9)
|
12.13 units on a scale
STANDARD_DEVIATION 6.57 • n=5 Participants
|
15.12 units on a scale
STANDARD_DEVIATION 5.17 • n=7 Participants
|
13.28 units on a scale
STANDARD_DEVIATION 6.20 • n=5 Participants
|
|
Clinician-Administered PTSD Scale Severity Score (CAPS)
|
66.02 units on a scale
STANDARD_DEVIATION 14.85 • n=5 Participants
|
72.98 units on a scale
STANDARD_DEVIATION 14.64 • n=7 Participants
|
67.11 units on a scale
STANDARD_DEVIATION 17.83 • n=5 Participants
|
|
Posttraumatic Cognitions Inventory (PTCI)
|
3.14 units on a scale
STANDARD_DEVIATION 1.07 • n=5 Participants
|
3.78 units on a scale
STANDARD_DEVIATION 1.07 • n=7 Participants
|
3.45 units on a scale
STANDARD_DEVIATION 1.13 • n=5 Participants
|
|
State-Trait Anxiety Inventory State Scale (STAI-S)
|
44.46 units on a scale
STANDARD_DEVIATION 5.46 • n=5 Participants
|
41.67 units on a scale
STANDARD_DEVIATION 6.13 • n=7 Participants
|
43.08 units on a scale
STANDARD_DEVIATION 5.96 • n=5 Participants
|
|
Sheehan Disability Scale (SDS)
|
18.15 units on a scale
STANDARD_DEVIATION 8.03 • n=5 Participants
|
18.83 units on a scale
STANDARD_DEVIATION 7.95 • n=7 Participants
|
18.19 units on a scale
STANDARD_DEVIATION 8.09 • n=5 Participants
|
|
Global Neuropsychological Deficits (Standardized, Composite)
|
.32 standardized units on a scale
STANDARD_DEVIATION .33 • n=5 Participants
|
.42 standardized units on a scale
STANDARD_DEVIATION .41 • n=7 Participants
|
.38 standardized units on a scale
STANDARD_DEVIATION .38 • n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe PTSD Checklist is a self-report questionnaire about PTSD symptoms. The version used in this study is called the PCL-S, which denotes a specific traumatic event for subjects to respond to. There are 17 items, each with response categories from 1 to 5. Thus, the total score ranges from 17 to 85. Higher scores reflect higher levels of PTSD symptoms, and a score of 50 or above is commonly interpreted to designate clinically significant PTSD symptoms.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
PTSD Checklist (PCL)
Baseline
|
57.46 units on a scale
Standard Deviation 12.66
|
59.98 units on a scale
Standard Deviation 11.80
|
|
PTSD Checklist (PCL)
Post-Treatment
|
47.00 units on a scale
Standard Deviation 18.91
|
58.06 units on a scale
Standard Deviation 12.31
|
|
PTSD Checklist (PCL)
6-Month Follow-Up
|
58.37 units on a scale
Standard Deviation 13.77
|
58.31 units on a scale
Standard Deviation 10.88
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe PHQ-9 is a self-report questionnaire about depressive symptoms. There are 9 scored items, each with response categories from 0 (zero) to 3. Thus, the total score ranges from 0 to 27. Higher scores reflect higher levels of depressive symptoms, with interpretation as follows: 0 (zero) No depression 1-4 Minimal depression 5-9 Mild depression 10-14 Moderate depression 15-19 Moderately severe depression 20-27 Severe depression
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Patient Health Questionnaire Depression Subscale (PHQ-9)
Baseline
|
12.13 units on a scale
Standard Deviation 6.57
|
15.12 units on a scale
Standard Deviation 5.17
|
|
Patient Health Questionnaire Depression Subscale (PHQ-9)
Post-Treatment
|
10.88 units on a scale
Standard Deviation 7.67
|
14.80 units on a scale
Standard Deviation 5.75
|
|
Patient Health Questionnaire Depression Subscale (PHQ-9)
6-Month Follow-Up
|
13.12 units on a scale
Standard Deviation 6.15
|
13.92 units on a scale
Standard Deviation 6.42
|
PRIMARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe CAPS is a clinician-administered interview about PTSD symptoms. There are 17 scored items for PTSD severity, each with response categories from 0 (zero) to 4 separately for both frequency and severity. Thus, each item can receive a score of 0 (zero) to 8, and the total severity score ranges from 0 to 136. Higher scores reflect higher levels of PTSD symptoms. Scores of 60 or above are generally considered clinically significant, and changes of 10 points or more (e.g., between pre-treatment and post-treatment) are considered clinically significant changes.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Clinician-Administered PTSD Scale Severity Score (CAPS)
Baseline
|
66.02 units on a scale
Standard Deviation 14.85
|
72.98 units on a scale
Standard Deviation 14.64
|
|
Clinician-Administered PTSD Scale Severity Score (CAPS)
Post-Treatment
|
48.48 units on a scale
Standard Deviation 24.58
|
64.45 units on a scale
Standard Deviation 15.32
|
|
Clinician-Administered PTSD Scale Severity Score (CAPS)
6-Month Follow-Up
|
29.16 units on a scale
Standard Deviation 34.20
|
37.40 units on a scale
Standard Deviation 32.74
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe PTCI is a self-report questionnaire about thoughts following traumatic events. There are 33 scored items, each with response categories from 1 (Totally Disagree) to 7 (Totally Agree), summed to create the total score. Thus, the total score ranges from 7 to 231. Higher scores reflect higher levels of negative cognitions.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Posttraumatic Cognitions Inventory (PTCI)
Baseline
|
3.14 units on a scale
Standard Deviation 1.07
|
3.78 units on a scale
Standard Deviation 1.07
|
|
Posttraumatic Cognitions Inventory (PTCI)
Post-Treatment
|
2.80 units on a scale
Standard Deviation 1.08
|
3.72 units on a scale
Standard Deviation 1.04
|
|
Posttraumatic Cognitions Inventory (PTCI)
6-Month Follow-Up
|
3.44 units on a scale
Standard Deviation 1.09
|
3.84 units on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe STAI-S is a self-report questionnaire about state (present state) anxiety. There are 20 scored items, each with response categories from 1 (Not at All) to 4 (Very Much So). Some items (e.g., "I feel calm") are reversed scored so that the total score appropriately reflects state anxiety. Thus, the total score ranges from 20 to 80. Higher scores reflect higher levels of state anxiety.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
State-Trait Anxiety Inventory State Scale (STAI-S)
Baseline
|
44.46 units on a scale
Standard Deviation 5.46
|
41.67 units on a scale
Standard Deviation 6.13
|
|
State-Trait Anxiety Inventory State Scale (STAI-S)
Post-Treatment
|
42.64 units on a scale
Standard Deviation 5.81
|
43.75 units on a scale
Standard Deviation 5.10
|
|
State-Trait Anxiety Inventory State Scale (STAI-S)
6-Month Follow-Up
|
43.72 units on a scale
Standard Deviation 5.96
|
42.63 units on a scale
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatment, and 6-month follow-upThe SDS is a self-report questionnaire about functioning. There are 3 scored items (Work/School; Social Life; and Family Life/Home Responsibilities), each with response categories from 0 (zero; Not at All) to 10 (Extremely). Thus, the total score ranges from 0 to 30. Higher scores reflect lower (poorer) levels of functioning.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
6-Month Follow-Up
|
21.06 units on a scale
Standard Deviation 7.44
|
17.71 units on a scale
Standard Deviation 7.10
|
|
Sheehan Disability Scale (SDS)
Baseline
|
18.15 units on a scale
Standard Deviation 8.03
|
18.83 units on a scale
Standard Deviation 7.95
|
|
Sheehan Disability Scale (SDS)
Post-Treatment
|
15.31 units on a scale
Standard Deviation 8.89
|
18.77 units on a scale
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: Pre-treatment, post-treatmentAmong our battery of seven neuropsychological tests, we worked with our neuropsychologist to choose 13 key scales. We used a conversion system to equally weight areas where there were large deficits, even if there were only one or two deficits, to prevent such scores from being minimized among the large range of T scores for the other scales. We converted T scores as follows: \>40 = 0; 35-39 = 1; 30-34 = 2; 25-29 = 3; 20-24 = 4; \< 20 = 5. Higher scores mean a higher global cognitive deficit.
Outcome measures
| Measure |
Prolonged Exposure Therapy (PE)
n=41 Participants
Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
|
Relaxation Training (RT)
n=46 Participants
Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
|
|---|---|---|
|
Global Neuropsychological Deficits (Standardized, Composite)
Baseline
|
.32 standardized units on a scale
Standard Deviation .33
|
.42 standardized units on a scale
Standard Deviation .41
|
|
Global Neuropsychological Deficits (Standardized, Composite)
Post-Treatment
|
.35 standardized units on a scale
Standard Deviation .42
|
.40 standardized units on a scale
Standard Deviation .42
|
Adverse Events
Prolonged Exposure Therapy (PE)
Relaxation Training (RT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Steven R. Thorp, Ph.D., ABPP
VA San Diego Healthcare System
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place