Exposure Therapy For Veterans With PTSD And Panic Attacks

NCT ID: NCT01033136

Last Updated: 2018-09-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-01-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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PTSD Panic Attacks

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.

Study Groups

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MCET-V

Multiple Channel Exposure Therapy -Veterans (MCET-V) is a 12-session cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks. It is an integrated treatment designed to target panic and PTSD symptoms simultaneously.

Group Type EXPERIMENTAL

Multiple Channel Exposure Therapy - Veterans

Intervention Type BEHAVIORAL

MCET-V offers individual therapy that provides psychoeducation about panic attacks and trauma and involves behavioral and cognitive exposure exercises.

CPT

Cognitive Processing Therapy (CPT) is a 12-session cognitive-behavioral treatment for persons with PTSD. It is a gold-standard cognitive behavioral intervention designed to target PTSD symptoms.

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.

Interventions

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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.

Intervention Type BEHAVIORAL

Cognitive Processing Therapy

CPT offers individual therapy that targets trauma and PTSD symptoms via cognitive restructuring.

Intervention Type BEHAVIORAL

Other Intervention Names

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MCET-V CPT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen Teng, PhD

Role: PRINCIPAL_INVESTIGATOR

Michael E. DeBakey VA Medical Center, Houston, TX

Locations

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Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CDA2-012-09F

Identifier Type: -

Identifier Source: org_study_id

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