Dexamethasone Plus Virtual Reality Exposure Therapy for PTSD

NCT ID: NCT01965366

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2017-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexamethasone + VRE

0.5 mg DEX + virtual reality exposure therapy

Group Type: ACTIVE_COMPARATOR

Virtual reality exposure therapy

Intervention Type: 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.

0.5 mg DEX

Intervention Type: 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.

Placebo + VRE

Placebo + virtual reality exposure therapy

Group Type: PLACEBO_COMPARATOR

Virtual reality exposure therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

Other Intervention Names

Dexamethasone

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).

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Barbara O. Rothbaum, PhD

Professor in Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara Rothbaum, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00068205

Identifier Type: -

Identifier Source: org_study_id