ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01551199
Recruitment Status : Completed
First Posted : March 12, 2012
Results First Posted : January 13, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease Intervention/treatment Phase
PTSD Panic Attacks Behavioral: Multiple Channel Exposure Therapy- Veterans Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Study Start Date : March 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Multiple Channel Exposure Therapy
MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
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.
Other Name: MCET-V




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 1-week post-treatment (approximately week 14) ]
    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 (daily/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.

  2. Clinician Administered PTSD Scale (CAPS) [ Time Frame: 3-month follow-up (approximately week 26) ]
    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 (daily/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.


Secondary Outcome Measures :
  1. Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV) [ Time Frame: 3 Months ]
    The ADIS-IV is a semi-structured diagnostic interview for anxiety disorders (based on DSM-IV criteria). DSM-IV criteria for panic disorder include recurrent unexpected panic attacks and (1) persistant concern or worry about additional panic attacks or their consequences or (2) significant change in behavior related to panic attacks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01551199


Locations
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Ellen Teng, PhD Michael E. DeBakey VA Medical Center, Houston, TX

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01551199     History of Changes
Other Study ID Numbers: CDA2-012-09F-1
First Posted: March 12, 2012    Key Record Dates
Results First Posted: January 13, 2015
Last Update Posted: February 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Panic Disorder
Anxiety Disorders
Mental Disorders