Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

NCT01965366 | Completed Phase 4 Results

• 1 other identifier: IRB00068205
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Keywords

Dexamethasone; Virtual Reality; Military; PTSD

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and immediate post treatment (up to 12 weeks from baseline)

Secondary Outcomes (1)

• Change in The PTSD Symptom Scale Scores

  Baseline and immediate post treatment (up to 12 weeks from baseline)

Study Arms (2)

Dexamethasone + VRE

ACTIVE COMPARATOR

0.5 mg DEX + virtual reality exposure therapy

Behavioral: Virtual reality exposure therapy; Drug: 0.5 mg DEX

Placebo + VRE

PLACEBO COMPARATOR

Placebo + virtual reality exposure therapy

Behavioral: Virtual reality exposure therapy

Interventions

Virtual reality exposure therapy BEHAVIORAL

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.

Dexamethasone + VRE; Placebo + VRE

0.5 mg DEX DRUG

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.

Also known as: Dexamethasone

Dexamethasone + VRE

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30306, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Virtual Reality Exposure Therapy; Dexamethasone

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr. Barbara Rothbaum
• Organization: Emory University

brothba@emory.edu

404-712-8866

Study Officials

• Barbara Rothbaum, Ph.D.

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 18, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-07

Locations

US (1)