Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)

PTSD Clinical Trial

Official title:

Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551199
• Other study ID #: CDA2-012-09F-1
• Status: Completed
• Phase: Phase 1
• First received: March 2, 2012
• Last updated: January 27, 2015
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: January 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• 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 posttraumatic stress disorder (PTSD) and panic disorder (PD) in two phases. The first phase of the study will examine the feasibility and acceptability of MCET-V.

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 first phase of the study is to evaluate the feasibility and acceptability of the multi-component cognitive-behavioral treatment in an open trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• being a veteran of any era;

• being enrolled in the Trauma Recovery Program (TRP) at the Michael E. DeBakey Veterans Affairs Medical Center (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 Structured Clinical Interview for DSM-IV disorders [SCID-IV] & Beck Depression Inventory-2nd edition [BDI-II]);

• cognitive impairment as indicated by the St. Louis University Mental Status exam (SLUMS); and

• veterans currently receiving psychosocial treatment specifically targeting PTSD or panic symptoms.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Attacks
• Panic Disorder
• PTSD

Intervention

Behavioral:
• Multiple Channel Exposure Therapy- Veterans
Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.

Locations

Country	Name	City	State
United States	Michael E DeBakey VA Medical Center	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	Clinician Administered PTSD Scale (CAPS)	The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (dailly/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.	1-week post-treatment (approximately week 14)	No
Primary	Clinician Administered PTSD Scale (CAPS)	The CAPS is a clinician-administered interview assessing 17 symptoms of PTSD (based on DSM-IV criteria). Frequency of symptoms are rated on a scale from 0 (never/none) to 4 (dailly/almost every day). Intensity of symptoms are rated using a scale of 0 (none) to 4 (extreme). Total severity score is derived by summing the frequency and intensity scores. A recommended cut-off of 45 is used to determine the presence of full PTSD. Higher scores suggest greater symptom severity.	3-month follow-up (approximately week 26)	No
Secondary	Anxiety Disorders Interview Schdule- DSM-IV (ADIS-IV)	The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV crtieria for panic disorder include recurrent unexpected panic attacks and (1) persisent concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.	3 Months	No