Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exposure Therapy For Veterans With PTSD And Panic Attacks

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01033136
First received: December 3, 2009
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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 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 Intervention
PTSD
Panic Attacks
Behavioral: Multiple Channel Exposure Therapy-Veterans
Behavioral: Cognitive-Processing Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exposure Therapy for Veterans With PTSD and Panic Attacks

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • CAPS [ Time Frame: 1-week post-treatment and 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADIS [ Time Frame: Baseline and 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: January 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Behavioral: 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.
Other Name: MCET-V
Behavioral: 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.
Other Name: CPT
Active Comparator: Arm 2
CPT is a cognitive-behavioral treatment for persons with PTSD
Behavioral: 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.
Other Name: CPT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033136

Contacts
Contact: Adriana Osegueda, BS (713) 791-1414 ext 26384 adriana.osegueda@va.gov

Locations
United States, Texas
Michael E DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Adriana Osegueda, BS    713-791-1414 ext 26384    adriana.osegueda@va.gov   
Principal Investigator: Ellen Teng, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Ellen Teng, PhD Michael E DeBakey VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01033136     History of Changes
Other Study ID Numbers: CDA2-012-09F
Study First Received: December 3, 2009
Last Updated: October 21, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014