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Exposure Therapy For Veterans With PTSD And Panic Attacks

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

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) in two phases. The second phase of the study will examine the effectiveness of MCET-V by comparing it to Cognitive Processing Therapy, a standard PTSD treatment.

Condition or disease Intervention/treatment Phase
PTSD Panic Attacks Behavioral: Multiple Channel Exposure Therapy - Veterans Behavioral: Cognitive Processing Therapy Not Applicable

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 second phase 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
Masking: Single (Outcomes Assessor)
Masking Description: Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
Primary Purpose: Treatment
Official Title: Exposure Therapy for Veterans With PTSD and Panic Attacks
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : January 1, 2017

Arm Intervention/treatment
Experimental: MCET-V
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.
Behavioral: Multiple Channel Exposure Therapy - Veterans
MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.
Other Name: MCET-V

Active Comparator: CPT
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.
Behavioral: Cognitive Processing Therapy
CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.
Other Name: CPT




Primary Outcome Measures :
  1. Rate of Decrease in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups [ Time Frame: Baseline, 1-week post-treatment and 3-month follow-up ]
    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.

  2. Change in PDSS Scores Over Time for MCET-V and CPT Groups [ Time Frame: Baseline, 1-week post, and 3-month follow-up ]
    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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01033136


Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ellen Teng, PhD Michael E. DeBakey VA Medical Center, Houston, TX

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01033136     History of Changes
Other Study ID Numbers: CDA2-012-09F
First Posted: December 16, 2009    Key Record Dates
Results First Posted: July 20, 2018
Last Update Posted: July 20, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders