Overview

This trial is active, not recruiting.

Conditions ptsd, panic attacks
Treatments multiple channel exposure therapy-veterans, cognitive-processing therapy
Sponsor VA Office of Research and Development
Start date January 2013
End date September 2016
Trial size 62 participants
Trial identifier NCT01033136, CDA2-012-09F

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
multiple channel exposure therapy-veterans MCET-V
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.
cognitive-processing therapy CPT
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.
(Active Comparator)
CPT is a cognitive-behavioral treatment for persons with PTSD
cognitive-processing therapy CPT
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.

Primary Outcomes

Measure
CAPS
time frame: 1-week post-treatment and 3-month follow-up

Secondary Outcomes

Measure
ADIS
time frame: Baseline and 3-month follow-up

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Exposure Therapy for Veterans With PTSD and Panic Attacks
Principal investigator Ellen Teng, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by VA Office of Research and Development.