Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Primary Purpose
PTSD, Panic Attacks
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Multiple Channel Exposure Therapy- Veterans
Sponsored by
About this trial
This is an interventional treatment trial for PTSD
Eligibility 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.
Sites / Locations
- Michael E. DeBakey VA Medical Center, Houston, TX
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multiple Channel Exposure Therapy
Arm Description
MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Outcomes
Primary Outcome Measures
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 (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.
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 (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
Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)
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.
Full Information
NCT ID
NCT01551199
First Posted
March 2, 2012
Last Updated
January 4, 2017
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01551199
Brief Title
Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Official Title
Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Panic Attacks
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple Channel Exposure Therapy
Arm Type
Experimental
Arm Description
MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks
Intervention Type
Behavioral
Intervention Name(s)
Multiple Channel Exposure Therapy- Veterans
Other Intervention Name(s)
MCET-V
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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.
Time Frame
1-week post-treatment (approximately week 14)
Title
Clinician Administered PTSD Scale (CAPS)
Description
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.
Time Frame
3-month follow-up (approximately week 26)
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule- DSM-IV (ADIS-IV)
Description
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.
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Teng, PhD
Organizational Affiliation
Michael E. DeBakey VA Medical Center, Houston, TX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exposure Therapy for Veterans With PTSD and Panic Attacks (Phase 1)
We'll reach out to this number within 24 hrs