Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01965366
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
PTSD	Behavioral: Virtual reality exposure therapy; Drug: 0.5 mg DEX	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of the Effects of Dexamethasone Administration on Virtual Reality Exposure Therapy for PTSD
• Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Dexamethasone + VRE 0.5 mg DEX + virtual reality exposure therapy	Behavioral: Virtual reality exposure therapy; 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.; Drug: 0.5 mg DEX; 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.; Other Names: Dexamethasone
Placebo Comparator: Placebo + VRE Placebo + virtual reality exposure therapy	Behavioral: Virtual reality exposure therapy; 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.

Outcome Measures

Primary Outcome Measures

1. Change in The Clinician Administered PTSD Scale (CAPS)Scores [Baseline and immediate post treatment (up to 12 weeks from baseline)]

   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

1. Change in The PTSD Symptom Scale Scores [Baseline and immediate post treatment (up to 12 weeks from baseline)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30306

Sponsors and Collaborators

• Emory University

Investigators

• Principal Investigator: Barbara Rothbaum, Ph.D., Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 23, 2015

More Information

Publications

None provided.

• Responsible Party: Barbara O. Rothbaum, PhD, Professor in Psychiatry, Emory University
• ClinicalTrials.gov Identifier: NCT01965366
• Other Study ID Numbers: IRB00068205
• First Posted: Oct 18, 2013
• Last Update Posted: Jul 12, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by Barbara O. Rothbaum, PhD, Professor in Psychiatry, Emory University: Dexamethasone; Virtual Reality; Military; PTSD
• Additional relevant MeSH terms: Stress Disorders, Post-Traumatic; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	Dexamethasone + VRE	Placebo + VRE
Arm/Group Description	0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: 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. 0.5 mg DEX: 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.	Placebo + virtual reality exposure therapy Virtual reality exposure therapy: 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.
Period Title: Overall Study
STARTED	13	14
COMPLETED	3	9
NOT COMPLETED	10	5

Baseline Characteristics

Arm/Group Title	Dexamethasone + VRE	Placebo + VRE	Total
Arm/Group Description	0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: 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. 0.5 mg DEX: 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.	Placebo + virtual reality exposure therapy Virtual reality exposure therapy: 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.	Total of all reporting groups
Overall Participants	13	14	27
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 100%	14 100%	27 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	13 100%	14 100%	27 100%
Race/Ethnicity, Customized (Count of Participants)
white	5 38.5%	5 35.7%	10 37%
black	5 38.5%	7 50%	12 44.4%
other	3 23.1%	2 14.3%	5 18.5%
Region of Enrollment (participants) [Number]
United States	13 100%	14 100%	27 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone + VRE	Placebo + VRE
Arm/Group Description	0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: 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. 0.5 mg DEX: 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.	Placebo + virtual reality exposure therapy Virtual reality exposure therapy: 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.
Measure Participants	3	9
Mean (Standard Deviation) [units on a scale]	-11 (10.44)	-15.22 (12.40)

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexamethasone + VRE	Placebo + VRE
Arm/Group Description	0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: 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. 0.5 mg DEX: 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.	Placebo + virtual reality exposure therapy Virtual reality exposure therapy: 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.
Measure Participants	3	9
Mean (Standard Deviation) [units on a scale]	-9 (16.97)	-16.65 (12.69)

Adverse Events

Time Frame	12 months of follow up
Arm/Group Title	Dexamethasone + VRE		Placebo + VRE
Arm/Group Description	0.5 mg DEX + virtual reality exposure therapy Virtual reality exposure therapy: 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. 0.5 mg DEX: 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.		Placebo + virtual reality exposure therapy Virtual reality exposure therapy: 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.
All Cause Mortality
	Dexamethasone + VRE		Placebo + VRE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Serious Adverse Events
	Dexamethasone + VRE		Placebo + VRE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Dexamethasone + VRE		Placebo + VRE
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.