PTSD
Conditions
Keywords
Dexamethasone, Virtual Reality, Military, PTSD
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.
Interventions
BEHAVIORALVirtual 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.
DRUG0.5 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.
Sponsors
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone + VRE 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. | 13 |
| Placebo + VRE 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. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Dexamethasone + VRE | Placebo + VRE | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Race/Ethnicity, Customized black | 5 Participants | 7 Participants | 12 Participants |
| Race/Ethnicity, Customized other | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized white | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 13 Participants | 14 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 14 |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
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.
Time frame: Baseline and immediate post treatment (up to 12 weeks from baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone + VRE | Change in The Clinician Administered PTSD Scale (CAPS)Scores | -11 units on a scale | Standard Deviation 10.44 |
| Placebo + VRE | Change in The Clinician Administered PTSD Scale (CAPS)Scores | -15.22 units on a scale | Standard Deviation 12.4 |
Secondary
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.
Time frame: Baseline and immediate post treatment (up to 12 weeks from baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone + VRE | Change in The PTSD Symptom Scale Scores | -9 units on a scale | Standard Deviation 16.97 |
| Placebo + VRE | Change in The PTSD Symptom Scale Scores | -16.65 units on a scale | Standard Deviation 12.69 |