Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Virtual reality exposure therapy; 0.5 mg DEX
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.; 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.
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 27.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dexamethasone; Virtual Reality; Military; PTSD

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.
    

Eligibility criteria:

        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).