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OpenTrials
Completed

NCT Number: NCT01033136

Exposure Therapy For Veterans With PTSD And Panic Attacks

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.

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Key information

Conditions

PTSD Anxiety Disorders Mental Disorders Panic Attacks Panic Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multiple Channel Exposure Therapy - Veterans

Behavioral

MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.

Other names: MCET-V

cognitive processing therapy

Behavioral

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

Other names: CPT

Primary outcomes

  1. Change 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Dec 16, 2009
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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