Exposure Therapy For Veterans With PTSD And Panic Attacks

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.

Study Overview

• Status: Completed
• Conditions: PTSD; Panic Attacks
• Intervention / Treatment: Behavioral: Multiple Channel Exposure Therapy - Veterans; Behavioral: Cognitive Processing Therapy

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 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.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E. DeBakey VA Medical Center, Houston, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MCET-V; Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.	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.; Other Names: MCET-V
Active Comparator: CPT; Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.	Behavioral: Cognitive Processing Therapy; CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.; Other Names: CPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): September 30, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: August 17, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder
• Other Study ID Numbers: CDA2-012-09F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No