ClinicalTrials.gov
ClinicalTrials.gov Menu

Exposure Therapy For Veterans With PTSD And Panic Attacks

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: NCT01033136
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : July 20, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions PTSD
Panic Attacks
Interventions Behavioral: Multiple Channel Exposure Therapy - Veterans
Behavioral: Cognitive Processing Therapy
Enrollment 93

Recruitment Details A total of 93 participants were recruited for the study. Of these participants, 68 met study inclusion criteria and were included in data analyses.
Pre-assignment Details  
Arm/Group Title Multiple Channel Exposure Therapy (MCET-V) Cognitive Processing Therapy (CPT)
Hide Arm/Group Description 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. 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.
Period Title: Baseline Assessment
Started 36 32
Completed 30 26
Not Completed 6 6
Period Title: Post-Treatment (1 Week)
Started 30 26
Completed 16 15
Not Completed 14 11
Period Title: Follow-Up (3 Month)
Started 16 15
Completed 14 13
Not Completed 2 2
Reason Not Completed
Lost to Follow-up             2             2
Arm/Group Title Multiple Channel Exposure Therapy (MCET-V) Cognitive Processing Therapy (CPT) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 36 32 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  91.7%
29
  90.6%
62
  91.2%
>=65 years
3
   8.3%
3
   9.4%
6
   8.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 32 participants 68 participants
42.61  (13.70) 41.56  (13.26) 42.12  (13.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
Female
7
  19.4%
7
  21.9%
14
  20.6%
Male
29
  80.6%
25
  78.1%
54
  79.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 32 participants 68 participants
White
17
  47.2%
12
  37.5%
29
  42.6%
African American
10
  27.8%
13
  40.6%
23
  33.8%
Latino
7
  19.4%
6
  18.8%
13
  19.1%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Other
2
   5.6%
1
   3.1%
3
   4.4%
1.Primary Outcome
Title Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
Hide Description 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.
Time Frame Baseline, 1-week post-treatment and 3-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multiple Channel Exposure Therapy (MCET-V) Cognitive Processing Therapy (CPT)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-Treatment 81.8  (21) 80.5  (19.9)
Post-Treatment (1 week) 67.8  (24.2) 68.1  (26.4)
Follow-Up (3 months) 66.6  (20.4) 66.2  (28.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Multiple Channel Exposure Therapy (MCET-V), Cognitive Processing Therapy (CPT)
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments To test if MCET is equivalent to CPT in decreasing PTSD symptoms, we test the equivalence of the proportion of patients whose CAPS scores decrease by 10 from baseline, by testing whether the difference in proportions between the 2 interventions ≤ to the equivalence margin δb of .20. Results are reported based on 3-month follow-up data.
Statistical Test of Hypothesis P-Value 0.30
Comments The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Change in PDSS Scores Over Time for MCET-V and CPT Groups
Hide Description The 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.
Time Frame Baseline, 1-week post, and 3-month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Multiple Channel Exposure Therapy -Veterans (MCET-V) Cognitive Processing Therapy (CPT)
Hide Arm/Group Description:
Multiple Channel Exposure Therapy -Veterans (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) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.
Overall Number of Participants Analyzed 36 32
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 18.5  (3.84) 16.28  (4.57)
1-week post 12.81  (6.33) 10.20  (5.75)
3-month follow up 10.93  (7.53) 10.62  (6.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Multiple Channel Exposure Therapy -Veterans (MCET-V), Cognitive Processing Therapy (CPT)
Comments Longitudinal analysis of PDSS scores
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments The threshold for statistical significance is p <.05 and is not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments Degrees of freedom: 2, 54
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Multiple Channel Exposure Therapy -Veterans (MCET-V) Cognitive Processing Therapy (CPT)
Hide Arm/Group Description

MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks

Multiple Channel Exposure Therapy-Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.

CPT is a cognitive-behavioral treatment for persons with PTSD

Cognitive-Processing Therapy: Participants will be randomly assigned to receive either MCET-V or cognitive processing therapy (CPT), a standard PTSD treatment. Patients in both the MCET-V and CPT conditions will receive 12, 90-minute sessions of individual therapy twice a week over a 6-week period.

All-Cause Mortality
Multiple Channel Exposure Therapy -Veterans (MCET-V) Cognitive Processing Therapy (CPT)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multiple Channel Exposure Therapy -Veterans (MCET-V) Cognitive Processing Therapy (CPT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Multiple Channel Exposure Therapy -Veterans (MCET-V) Cognitive Processing Therapy (CPT)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/32 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ellen Teng
Organization: Michael E. DeBakey VA Medical Center
Phone: (713) 578-5513
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01033136     History of Changes
Other Study ID Numbers: CDA2-012-09F
First Submitted: December 3, 2009
First Posted: December 16, 2009
Results First Submitted: September 29, 2017
Results First Posted: July 20, 2018
Last Update Posted: September 17, 2018