Enhancing Exposure Therapy for Post Traumatic Stress Disorder (PTSD): Virtual Reality and Imaginal Exposure With a Cognitive Enhancer

This study is currently recruiting participants.
Verified November 2013 by Weill Medical College of Cornell University
Sponsor:
Collaborators:
Emory University
University of Southern California
VA Long Beach Healthcare System
National Intrepid Center of Excellence (NICoE)
Information provided by (Responsible Party):
Joann Difede, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01352637
First received: February 18, 2011
Last updated: November 22, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to test the differences between four active treatment conditions for combat-related Post Traumatic Stress Disorder (PTSD): virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both with DCS or placebo, as well as to examine predictors for PTSD and response to treatment in active duty military personnel, veterans, and civilians who served in Iraq and Afghanistan.


Condition Intervention Phase
Post Traumatic Stress Disorder
Drug: DCS (D-Cycloserine ) + Prolonged Imaginal Exposure
Drug: DCS (D-Cycloserine ) + Virtual Reality Exposure
Drug: Placebo + Prolonged Imaginal Exposure
Drug: Placebo (sugar pill) + Virtual Reality Exposure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Enhancing Exposure Therapy for PTSD: Virtual Reality and Imaginal Exposure With a Cognitive Enhancer

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Change from Baseline in CAPS at mid-treatment [ Time Frame: after treatment session 4 and 6 ] [ Designated as safety issue: No ]
    CAPS (Clinician Administered PTSD Scale)is a structured clinical interview designed to assess the 17 DSM symptoms of PTSD. The CAPS provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on the subject's response to the 17 items that assess the frequency and intensity of current PTSD symptoms.

  • Change from Baseline in CAPS at end of treatment [ Time Frame: after treatment session 9 ] [ Designated as safety issue: No ]
  • Change from Baseline in CAPS at 3-month follow-up [ Time Frame: 3-months after treatment completion ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo + Prolonged Imaginal Exposure
Drug: Placebo (sugar pill) + Prolonged Imaginal Exposure (PE) PTSD treatment
Drug: Placebo + Prolonged Imaginal Exposure
Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure
Placebo Comparator: Placebo + VR exposure
Drug: Placebo (sugar pill) + Virtual Reality Exposure (VR) PTSD treatment
Drug: Placebo (sugar pill) + Virtual Reality Exposure
Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure
Active Comparator: DCS + Prolonged Imaginal Exposure
Drug: 50mg DCS (D-Cycloserine ) + Prolonged Imaginal Exposure (PE) PTSD treatment
Drug: DCS (D-Cycloserine ) + Prolonged Imaginal Exposure
50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure
Active Comparator: DCS+VR exposure
Drug: 50mg DCS (D-Cycloserine ) + Virtual Reality Exposure (VR) PTSD treatment
Drug: DCS (D-Cycloserine ) + Virtual Reality Exposure
50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure

Detailed Description:

Post Traumatic Stress Disorder (PTSD) is an anxiety disorder that can develop following exposure to traumatic events and includes symptoms of re-experiencing the trauma, such as through nightmares and flashbacks, avoidance and numbing, and physical hyperarousal. PTSD has been estimated to affect 10-20% of returning Operation Iraqi Freedom (OIF)/Operation Enduring Freedom (OEF) veterans. The most effective intervention found for PTSD is exposure therapy, which can be delivered in different formats, e. g. via virtual reality (VR) and as imaginal exposure. The goal of this study is to test the difference between 4 study conditions: virtual reality exposure therapy (VRE) or prolonged imaginal exposure therapy (PE), both combined with an antibiotic drug, DCS (active pill vs. placebo). D-Cycloserine (DCS), a drug that has been FDA approved for over 20 years, has been hypothesized to enhance the therapeutic effects of exposure therapy.). A secondary purpose of this study is to examine predictors for PTSD and response to PTSD intervention in active duty military personnel, veterans, and civilians who served in Iraq/Afghanistan. Psychophysiological factors (e.g. heart rate, blood pressure) and/or a genetic polymorphism (BDNF Val66Met) obtained from a saliva sample will be examined.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related PTSD;
  2. Female participants of childbearing potential must agree to use an effective method of birth control (i.e., oral contraceptive, Norplant, diaphragm, condom, or spermicide) during the course of the study, or to remain abstinent from sex, to ensure they do not become pregnant during the course of the study;
  3. Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments;
  4. Participants must be literate in English;
  5. Patients must be medically healthy and willing to take the study drug;
  6. VRE stimuli available must be consistent with subject's trauma.

Exclusion Criteria:

  1. Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder;
  2. Participation in a clinical trial during the previous 3 months;
  3. Current evidence or history of significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment;
  4. Patients who in the investigator's judgment pose a current suicidal or homicidal risk;
  5. Alcohol, medication, or illegal substance dependence within the past 90 days;
  6. Treatment with any other concomitant medication with primarily CNS activity, or treatment with any medication that the PI judges not acceptable for this study;
  7. history of seizures;
  8. Pregnancy or lactation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352637

Contacts
Contact: JoAnn Difede, Ph. D. 212 746 3079 jdifede@med.cornell.edu

Locations
United States, California
VA Long Beach Healthcare System Recruiting
Long Beach, California, United States
Contact: Christopher Reist, MD, MBA       chris.reist@va.gov   
University of Southern California Recruiting
Los Angeles, California, United States
Contact: Albert Rizzo, Ph.D.    213-610-4737    arizzo@usc.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States
Contact: Barbara Rothbaum, Ph.D., ABPP    404-712-8866    brothba@emory.edu   
United States, Maryland
Walter Reed Army Medical Center/National Intrepid Center of Excellence (NICoE) Recruiting
Bethesda, Maryland, United States
Contact: Michael Roy, MD MPH    301-295-9601    mroy@usuhs.mil   
United States, New York
Weill Cornell Medical College Recruiting
New York City/Westchester, New York, United States
Contact: JoAnn Difede, Ph. D.    212-746-3079    jdifede@med.cornell.edu   
Contact: Judith Cukor, Ph.D.    212 746 4492    juc2010@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Emory University
University of Southern California
VA Long Beach Healthcare System
National Intrepid Center of Excellence (NICoE)
Investigators
Principal Investigator: JoAnn Difede, Ph.D. Weill Medical College of Cornell University
Principal Investigator: Barbara Rothbaum, Ph.D., ABPP Emory University
Principal Investigator: Skip Rizzo, Ph. D. University of Southern California
  More Information

Additional Information:
No publications provided

Responsible Party: Joann Difede, Professor of Psychology in Psychiatry, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01352637     History of Changes
Other Study ID Numbers: 1005011047
Study First Received: February 18, 2011
Last Updated: November 22, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
Traumatic Event
Trauma Survivor
Exposure Therapy
PTSD DCS
Virtual Reality Exposure
Veteran
Combat-related PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Cycloserine
Nootropic Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 22, 2014