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

June 13, 2019 updated by: Weill Medical College of Cornell University

Enhancing Exposure Therapy for PTSD: Virtual Reality and Imaginal Exposure With a Cognitive Enhancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

The two primary co-aims are

  1. to examine the effects of DCS versus placebo (PLA) augmentation of exposure therapy on PTSD symptoms, and
  2. to examine the relative efficacy of virtual reality enhanced exposure therapy (VRE) and exposure therapy (PE) on PTSD symptoms.

Study Type

Interventional

Enrollment (Actual)

192

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States
        • University of Southern California
    • Georgia
      • Atlanta, Georgia, United States
        • Emory University
    • Maryland
      • Bethesda, Maryland, United States
        • Walter Reed Army Medical Center/National Intrepid Center of Excellence (NICoE)
    • New York
      • New York, New York, United States
        • Weill Cornell Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAPS-IV at the End of Treatment
Time Frame: after weekly treatment session 9 (at posttreatment assessment)

Clinician Administered PTSD Scale (CAPS) for the DSM-IV [34]. The CAPS-IV is a structured clinical interview designed to assess the 17 DSM-IV PTSD symptoms. CAPS-IV provides categorical ratings of diagnostic status as well as a quantitative index of symptom severity. The CAPS total severity score is based on response to the 17 items that assess the frequency and intensity of current PTSD symptoms. Symptom severity is assessed separately for past month and past week time frames.

CAPS-IV range is 0-136, higher scores mean a worse outcome.
after weekly treatment session 9 (at posttreatment assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Collaborators

United States Department of Defense
Emory University
University of Southern California
National Intrepid Center of Excellence
VA Long Beach Healthcare System

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2011

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (Estimate)

May 12, 2011

Study Record Updates

Last Update Posted (Actual)

July 2, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1005011047

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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