Back to resultsExposure Therapy For Veterans With PTSD And Panic Attacks
Primary Purpose
PTSD, Panic Attacks
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multiple Channel Exposure Therapy - Veterans
Cognitive Processing Therapy
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
Eligibility Criteria
Inclusion Criteria:
- being a Veteran of any era;
- being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD;
- being stable on psychotropic medication for 4 weeks before study participation; and
- being at least 18 years of age.
Exclusion Criteria:
- active substance dependence, or bipolar or psychotic disorders;
- severe depression and [active suicidal ideation and intent] (based on ADIS-IV & BDI-II);
- cognitive impairment as indicated by the SLUMS; and
- Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
Sites / Locations
- Michael E. DeBakey VA Medical Center, Houston, TX
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MCET-V
CPT
Arm 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.
Outcomes
Primary Outcome Measures
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
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.
Change in PDSS Scores Over Time for MCET-V and CPT Groups
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01033136
First Posted
December 3, 2009
Last Updated
August 17, 2018
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01033136
Brief Title
Exposure Therapy For Veterans With PTSD And Panic Attacks
Official Title
Exposure Therapy for Veterans With PTSD and Panic Attacks
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the feasibility, acceptability and effectiveness of Multiple Channel Exposure Therapy-Veterans (MCET-V) as a treatment for returning service members with comorbid PTSD and panic disorder (PD). This study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.
Detailed Description
With the increasing number of Operations Iraqi Freedom and Enduring Freedom (OIF/OEF) Veterans returning from war-zone areas, many will experience anxiety disorders such as PTSD and comorbid problems. Currently, about one in every six OIF/OEF Veterans experiences PTSD and co-occurring PD. Although effective treatments exist for treating one or the other, we do not yet have treatments that can simultaneously target PTSD and PD. Thus, recent attention has focused on the development of multi-component treatments that simultaneously address PTSD and PD. This study is the first systematic investigation of a time-limited, multi-component cognitive-behavioral treatment for Veterans with specific comorbid anxiety problems. The purpose of the study is to evaluate the effectiveness of the multi-component cognitive-behavioral treatment in comparison to standard PTSD treatment in military personnel returning from active duty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Panic Attacks
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
Masking
Outcomes Assessor
Masking Description
Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MCET-V
Arm Type
Experimental
Arm 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.
Arm Title
CPT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Multiple Channel Exposure Therapy - Veterans
Other Intervention Name(s)
MCET-V
Intervention Description
MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
Primary Outcome Measure Information:
Title
Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups
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
Title
Change in PDSS Scores Over Time for MCET-V and CPT Groups
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being a Veteran of any era;
being enrolled in the TRP at the MEDVAMC, with a current diagnosis of PTSD and PD;
being stable on psychotropic medication for 4 weeks before study participation; and
being at least 18 years of age.
Exclusion Criteria:
active substance dependence, or bipolar or psychotic disorders;
severe depression and [active suicidal ideation and intent] (based on ADIS-IV & BDI-II);
cognitive impairment as indicated by the SLUMS; and
Veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exposure Therapy For Veterans With PTSD And Panic Attacks
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