Recruitment

Recruitment Status
Completed
Estimated Enrollment
60

Inclusion Criterias

Patients must be literate in English.
Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
...
Patients must be literate in English.
Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
Participants must comprehend his or her role in the study and the risks involved in order to be entered.
Participants will be 60 males and females between ages of 21 and 65.

Exclusion Criterias

Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
Patients with current alcohol or drug dependence;
Patients unwilling to take study medication;
...
Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
Patients with current alcohol or drug dependence;
Patients unwilling to take study medication;
Patients with prominent suicidal ideation;
Patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. The concomitant use of psychotropic medications will be recorded and examined in data analyses.
Patients unable to tolerate wearing the VR helmet;
Patients stabilized on potentially data-obscuring medications (glucocorticoids).
Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
Patients with a history of mania, schizophrenia, or other psychoses;

Summary

Conditions
PTSD
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 65 years
Gender
Both males and females

Inclusion Criterias

Patients must be literate in English.
Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
...
Patients must be literate in English.
Participants must meet DSM-V criteria for PTSD due to exposure to a trauma while serving in Operation Iraqi Freedom and/or Operation Enduring Freedom-Afghanistan and Operation New Dawn.
Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
Participants must comprehend his or her role in the study and the risks involved in order to be entered.
Participants will be 60 males and females between ages of 21 and 65.

Exclusion Criterias

Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
Patients with current alcohol or drug dependence;
Patients unwilling to take study medication;
...
Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
Patients with current alcohol or drug dependence;
Patients unwilling to take study medication;
Patients with prominent suicidal ideation;
Patients on psychotropic medication(s) must have been on a stable dose for at least 2 weeks prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study. The concomitant use of psychotropic medications will be recorded and examined in data analyses.
Patients unable to tolerate wearing the VR helmet;
Patients stabilized on potentially data-obscuring medications (glucocorticoids).
Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
Patients with a history of mania, schizophrenia, or other psychoses;

Locations

Atlanta, Georgia, 30306
Atlanta, Georgia, 30306

Tracking Information

NCT #
NCT01965366
Collaborators
Not Provided
Investigators
  • Principal Investigator: Barbara Rothbaum, Ph.D. Emory University
  • Barbara Rothbaum, Ph.D. Emory University