Comparing Virtual Reality Exposure Therapy to Prolonged Exposure (VRPE Extension)

National Center for Telehealth and Technology

Status: Completed

Conditions: Post-Traumatic Stress Disorder; Stress Disorders

Treatments: Behavioral: Waitlist; Behavioral: Virtual Reality Exposure Therapy (VRET); Behavioral: Prolonged Exposure Therapy (PE)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01459705

W81XWH-11-2-0007 (Other Grant/Funding Number)

112226

Details and patient eligibility

About

This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

Full description

The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE.

Enrollment: 162 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• PTSD diagnosis as assessed by CAPS
• history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF)
• non sexually based deployment related trauma
• three or more months since index trauma
• stable on psychotropic medication for 30 days

Exclusion criteria

• index trauma in the last three months
• history of schizophrenia, other psychotic or bipolar disorder
• history of organic brain disorder
• suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months
• ongoing threatening situation
• current drug or alcohol dependence
• history of seizures
• prior history of PE for PTSD
• other current psychotherapy
• physical condition that interferes with proper use of Virtual Reality head mounted display
• history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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162 participants in 3 patient groups, including a placebo group

Prolonged Exposure Therapy (PE)

Active Comparator group

Description:

The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.

Treatment:

Behavioral: Prolonged Exposure Therapy (PE)

Virtual Reality Exposure Therapy (VRET)

Experimental group

Description:

The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.

Treatment:

Behavioral: Virtual Reality Exposure Therapy (VRET)

Waitlist

Placebo Comparator group

Description:

The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.

Treatment:

Behavioral: Waitlist