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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033136
Other study ID # CDA2-012-09F
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2013
Est. completion date January 1, 2017

Study information

Verified date August 2018
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date January 1, 2017
Est. primary completion date September 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
Cognitive Processing Therapy
CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.

Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center, Houston, TX Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline, 1-week post-treatment and 3-month follow-up
Primary 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. Baseline, 1-week post, and 3-month follow-up
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