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

NCT01352637 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2019-07-02

Study results available
· View outcomes & findings →

Summary

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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

DCS (D-Cycloserine ) + Prolonged Imaginal Exposure

50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

DRUG

DCS (D-Cycloserine ) + Virtual Reality Exposure

50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure

DRUG

Placebo + Prolonged Imaginal Exposure

Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure

DRUG

Placebo (sugar pill) + Virtual Reality Exposure

Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED
  • Emory University

    collaborator OTHER
  • University of Southern California

    collaborator OTHER
  • VA Long Beach Healthcare System

    collaborator FED
  • National Intrepid Center of Excellence

    collaborator FED
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • JoAnn Difede, Ph.D. · Weill Medical College of Cornell University

  • Barbara Rothbaum, Ph.D., ABPP · Emory University

  • Skip Rizzo, Ph. D. · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01352637 on ClinicalTrials.gov