Exposure Therapy For Veterans With PTSD And Panic Attacks

NCT01033136 | Completed Results DMC

• 1 other identifier: CDA2-012-09F
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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 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.

Conditions

PTSD; Panic Attacks

Outcome Measures

Primary Outcomes (2)

• Change in PTSD Symptoms (CAPS) Between MCET-V and CPT Groups

  The CAPS is a clinician-administered assessment of the presence and severity of PTSD symptoms. Scores range from 0 - 136, with higher scores indicating greater symptom severity.

  Baseline, 1-week post-treatment and 3-month follow-up

• Change in PDSS Scores Over Time for MCET-V and CPT Groups

  The Panic Disorder Severity Scale (PDSS) is a clinician-rated assessment of the presence and severity of panic symptoms. Scores range from 0 - 28, with higher scores indicating greater symptom severity.

  Baseline, 1-week post, and 3-month follow-up

Study Arms (2)

MCET-V

EXPERIMENTAL

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.

Behavioral: Multiple Channel Exposure Therapy - Veterans

CPT

ACTIVE COMPARATOR

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.

Behavioral: Cognitive Processing Therapy

Interventions

Multiple Channel Exposure Therapy - Veterans BEHAVIORAL

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

Also known as: MCET-V

MCET-V

Cognitive Processing Therapy BEHAVIORAL

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

Also known as: CPT

CPT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Panic Disorder

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders

Results Point of Contact

• Title: Dr. Ellen Teng
• Organization: Michael E. DeBakey VA Medical Center

Ellen.Teng@va.gov

(713) 578-5513

Study Officials

• Ellen Teng, PhD

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Post-treatment and follow-up assessments are conducted by an assessor masked to treatment condition.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Multiple Channel Exposure Therapy is a behavioral treatment that simultaneously targets panic disorder and PTSD.

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 16, 2009
• Study Start: January 1, 2013
• Primary Completion: September 30, 2016
• Study Completion: January 1, 2017
• Last Updated: September 17, 2018
• Results First Posted: July 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)