EXPOSURE THERAPY FOR VETERANS WITH PTSD AND PANIC ATTACKS - Full Text View

Sponsor:	Department of Veterans Affairs
Information provided by (Responsible Party):	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT01033136

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: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADIS [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment:	62
Study Start Date:	January 2013
Estimated Study Completion Date:	July 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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: 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

Arms

Assigned Interventions

Experimental: 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: 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 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

being an OIF/OEF veteran, defined as having received the Global War on Terrorism Expeditionary or Service Medal and/or being involved in combat after November 11, 1998;
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 SCID & BDI-II);
cognitive impairment as indicated by the SLUMS; and
veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.

Contacts and Locations

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

Contacts

Contact: Ken L Woods, BA	(713) 791-1414 ext 2247	kenw@bcm.tmc.edu
Contact: Emily L Hiatt	(713) 791-1414 ext 6408	emily.hiatt@va.gov

Locations

United States, District of Columbia
VA Central Office - HSR&D, Washington, DC	Not yet recruiting
Washington, District of Columbia, United States, 20420
Contact: Ken L Woods, BA 713-791-1414 ext 2247 kenw@bcm.tmc.edu
United States, Texas
Michael E DeBakey VA Medical Center	Not yet recruiting
Houston, Texas, United States, 77030
Contact: Ken L Woods, BA 713-791-1414 ext 2247 kenw@bcm.tmc.edu
Principal Investigator: Ellen Teng, PhD

Sponsors and Collaborators

Department of Veterans Affairs

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:	CDA-2-012-09F
Study First Received:	December 3, 2009
Last Updated:	January 30, 2012
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Panic Disorder
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012