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Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD (Dex)

Primary Purpose

PTSD

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Virtual reality exposure therapy
0.5 mg DEX
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring Dexamethasone, Virtual Reality, Military, PTSD

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants will be 60 males and females between ages of 21 and 65.
  2. 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.
  3. Patients must be literate in English.
  4. Patients must be medically healthy or medically stable such that the stress of VR and DEX are not contraindicated.
  5. Participants must comprehend his or her role in the study and the risks involved in order to be entered.

Exclusion Criteria:

  1. Patients with a history of mania, schizophrenia, or other psychoses;
  2. Patients with prominent suicidal ideation;
  3. Patients with current alcohol or drug dependence;
  4. Patients unable to tolerate wearing the VR helmet;
  5. Patients unwilling to take study medication;
  6. 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.
  7. Patients with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury
  8. Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician)
  9. Patients stabilized on potentially data-obscuring medications (glucocorticoids).

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Dexamethasone + VRE

Placebo + VRE

Arm Description

0.5 mg DEX + virtual reality exposure therapy

Placebo + virtual reality exposure therapy

Outcomes

Primary Outcome Measures

Change in The Clinician Administered PTSD Scale (CAPS)Scores
The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.

Secondary Outcome Measures

Change in The PTSD Symptom Scale Scores
The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = "not at all" to 3 = "5 or more times per week/very much"). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD.

Full Information

First Posted
October 11, 2013
Last Updated
July 10, 2018
Sponsor
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01965366
Brief Title
Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
Acronym
Dex
Official Title
A Pilot Study of the Effects of Dexamethasone Administration on Virtual Reality Exposure Therapy for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evidence from preliminary studies suggests that people with PTSD have heightened fear responses and that cortisol suppression reduces this heightened fear. Research has shown the drug dexamethasone (DEX), a cortisol suppressor, reduces the startle response in civilians with PTSD. This current research proposal represents a blinded, randomized, placebo-controlled efficacy study with the goal of determining whether a drug that suppresses the stress hormone cortisol will increase the efficacy of exposure therapy. Specifically, it is proposed that a dose of DEX, given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions, will significantly enhance the rate of response and possibly the efficacy of treatment. Participants will be treated until they have experienced at least a 70% reduction in PTSD symptoms from baseline or up to 12 sessions or until they and their therapist agree treatment should be terminated, a minimum of 6 sessions to a maximum of 12 sessions. Comprehensive multi-modal outcomes will be assessed by independent assessors blind to subject condition on interviews, self-report measures, and psychophysiological measures. Participants will be assessed pre- and post-treatment and at a follow-up of 3, 6 and 12 months to assess long term effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
Dexamethasone, Virtual Reality, Military, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dexamethasone + VRE
Arm Type
Active Comparator
Arm Description
0.5 mg DEX + virtual reality exposure therapy
Arm Title
Placebo + VRE
Arm Type
Placebo Comparator
Arm Description
Placebo + virtual reality exposure therapy
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality exposure therapy
Intervention Description
Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
Intervention Type
Drug
Intervention Name(s)
0.5 mg DEX
Other Intervention Name(s)
Dexamethasone
Intervention Description
A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
Primary Outcome Measure Information:
Title
Change in The Clinician Administered PTSD Scale (CAPS)Scores
Description
The Clinician Administered PTSD Scale (CAPS) provides a diagnostic measure of PTSD and a continuous measure of the severity, frequency, and intensity of the three symptom clusters (intrusion, avoidance, and arousal) and overall PTSD. The assessor combines information about frequency and intensity of an item into a single severity rating. Severity Rating: 0. Absent; 1. Mild / subthreshold;2. Moderate / threshold; 3. Severe / markedly elevated; 4.Extreme / incapacitating. The assessor combines information about frequency and intensity of an item into a single severity rating. CAPS-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Scores may range from 0-80, with a higher score indicating more reported symptoms of PTSD.
Time Frame
Baseline and immediate post treatment (up to 12 weeks from baseline)
Secondary Outcome Measure Information:
Title
Change in The PTSD Symptom Scale Scores
Description
The PTSD Symptom Scale (PSS) is a 17-item interview used to aid in the detection and diagnosis of PTSD. The structure and content of the PSS mirror the DSM-IV criteria for PTSD. For each item, the interviewer assigns a rating to reflect a combination of frequency and severity (from O = "not at all" to 3 = "5 or more times per week/very much"). Scores range from 0-51, with higher scores indicating more reported symptoms of PTSD. A score of 13 or higher indicates the likelihood of PTSD.
Time Frame
Baseline and immediate post treatment (up to 12 weeks from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be 60 males and females between ages of 21 and 65. 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 literate in English. 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. Exclusion Criteria: Patients with a history of mania, schizophrenia, or other psychoses; Patients with prominent suicidal ideation; Patients with current alcohol or drug dependence; Patients unable to tolerate wearing the VR helmet; Patients unwilling to take study medication; 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 with special medical conditions such as pregnancy, renal insufficiency, or a history of significant head injury Active medical disorders contributing to psychiatric sx e.g. hypo or hyperthyroidism, SLE, advanced cirrhosis, etc. (per clinical judgment of study physician) Patients stabilized on potentially data-obscuring medications (glucocorticoids).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Rothbaum, Ph.D.
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States

12. IPD Sharing Statement

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Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

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