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 April 2013 by Weill Medical College of Cornell University
Sponsor:
Weill Medical College of Cornell University
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: April 12, 2013
Last verified: April 2013
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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:
MedlinePlus related topics:
Post-Traumatic Stress Disorder
Drug Information available for:
Cycloserine
U.S. FDA Resources
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 Primary Completion Date: | July 2014 (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:
- Diagnosis of OEF-OIF (Operations Enduring Freedom or Iraqi Freedom) Combat Related PTSD;
- 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;
- Ability to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments;
- Participants must be literate in English;
- Patients must be medically healthy and willing to take the study drug;
- VRE stimuli available must be consistent with subject's trauma.
Exclusion Criteria:
- Lifetime or current diagnosis of schizophrenia or other psychotic disorder, bipolar disorder;
- Participation in a clinical trial during the previous 3 months;
- 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;
- Patients who in the investigator's judgment pose a current suicidal or homicidal risk;
- Alcohol, medication, or illegal substance dependence within the past 90 days;
- Treatment with any other concomitant medication with primarily CNS activity, or treatment with any medication that the PI judges not acceptable for this study;
- history of seizures;
- 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: | April 12, 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 May 16, 2013