Trial Outcomes & Findings for Exposure Therapy For Veterans With PTSD And Panic Attacks (NCT NCT01033136)
NCT ID: NCT01033136
Last Updated: 2018-09-17
Results Overview
The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
Baseline, 1-week post-treatment and 3-month follow-up
Results posted on
2018-09-17
Participant Flow
A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.
Participant milestones
| Measure |
Multiple Channel Exposure Therapy (MCET-V)
MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
|
Cognitive Processing Therapy (CPT)
CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
|
|---|---|---|
|
Baseline Assessment
STARTED
|
36
|
32
|
|
Baseline Assessment
COMPLETED
|
30
|
26
|
|
Baseline Assessment
NOT COMPLETED
|
6
|
6
|
|
Post-Treatment (1 Week)
STARTED
|
30
|
26
|
|
Post-Treatment (1 Week)
COMPLETED
|
16
|
15
|
|
Post-Treatment (1 Week)
NOT COMPLETED
|
14
|
11
|
|
Follow-Up (3 Month)
STARTED
|
16
|
15
|
|
Follow-Up (3 Month)
COMPLETED
|
14
|
13
|
|
Follow-Up (3 Month)
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Multiple Channel Exposure Therapy (MCET-V)
MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
|
Cognitive Processing Therapy (CPT)
CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
|
|---|---|---|
|
Follow-Up (3 Month)
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Exposure Therapy For Veterans With PTSD And Panic Attacks
Baseline characteristics by cohort
| Measure |
Multiple Channel Exposure Therapy (MCET-V)
n=36 Participants
MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
|
Cognitive Processing Therapy (CPT)
n=32 Participants
CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
42.61 years
STANDARD_DEVIATION 13.70 • n=5 Participants
|
41.56 years
STANDARD_DEVIATION 13.26 • n=7 Participants
|
42.12 years
STANDARD_DEVIATION 13.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latino
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 1-week post-treatment and 3-month follow-upThe CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Multiple Channel Exposure Therapy (MCET-V)
n=36 Participants
MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
|
Cognitive Processing Therapy (CPT)
n=32 Participants
CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
|
|---|---|---|
|
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Pre-Treatment
|
81.8 units on a scale
Standard Deviation 21
|
80.5 units on a scale
Standard Deviation 19.9
|
|
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Post-Treatment (1 week)
|
67.8 units on a scale
Standard Deviation 24.2
|
68.1 units on a scale
Standard Deviation 26.4
|
|
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Follow-Up (3 months)
|
66.6 units on a scale
Standard Deviation 20.4
|
66.2 units on a scale
Standard Deviation 28.0
|
PRIMARY outcome
Timeframe: Baseline, 1-week post, and 3-month follow-upThe Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.
Outcome measures
| Measure |
Multiple Channel Exposure Therapy (MCET-V)
n=36 Participants
MCET-V is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.
|
Cognitive Processing Therapy (CPT)
n=32 Participants
CPT is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
|
|---|---|---|
|
Change in PDSS Scores Over Time for MCET-V and CPT Groups
Baseline
|
18.5 units on a scale
Standard Deviation 3.84
|
16.28 units on a scale
Standard Deviation 4.57
|
|
Change in PDSS Scores Over Time for MCET-V and CPT Groups
1-week post
|
12.81 units on a scale
Standard Deviation 6.33
|
10.20 units on a scale
Standard Deviation 5.75
|
|
Change in PDSS Scores Over Time for MCET-V and CPT Groups
3-month follow up
|
10.93 units on a scale
Standard Deviation 7.53
|
10.62 units on a scale
Standard Deviation 6.51
|
Adverse Events
Multiple Channel Exposure Therapy -Veterans (MCET-V)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cognitive Processing Therapy (CPT)
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