Exposure Therapy For Veterans With PTSD And Panic Attacks

PTSD Clinical Trial

Official title:

Exposure Therapy for Veterans With PTSD and Panic Attacks

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01033136
• Other study ID #: CDA2-012-09F
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Panic Attacks
• Panic Disorder
• PTSD

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