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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01346241
Other study ID # H-28272
Secondary ID
Status Recruiting
Phase N/A
First received April 29, 2011
Last updated April 29, 2011
Start date April 2011
Est. completion date April 2013

Study information

Verified date April 2011
Source Michael Debakey Veterans Affairs Medical Center
Contact Ken Woods
Phone 713-791-1414
Email ken.woods@va.gov
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).


Description:

We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable)

Exclusion Criteria:

- Current substance dependence

- psychosis

- symptomatic bipolar disorder

- severe depression with suicidal intent or plan

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Intensive Panic Control Treatment (IPCT)
A manualized treatment that consists of psychoeducation about panic disorder

Locations

Country Name City State
United States Michael E. DeBakey VA Medical Center and CBOC's (Lufkin, Texas City, and Conroe) Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intensive Panic Control Treatment (IPCT) IPCT is a manualized treatment that consists of psychoeducation about panic disorder, behavioral exercises such as breathing retraining and interoceptive exposure to mimic symptoms during an actual panic attack, and cognitive restructuring (identifying thought distortions and replacing them with corrective thoughts based on realistic appraisals). 3 Months No
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