Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

Not Applicable

Completed

Conditions: Stress Disorders
Post-Traumatic Stress Disorder

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

Registration Number: NCT01459705

Lead Sponsor: National Center for Telehealth and Technology

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 162

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure Therapy (PE)	Prolonged Exposure Therapy (PE)	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.
Virtual Reality Exposure Therapy (VRET)	Virtual Reality Exposure Therapy (VRET)	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.
Waitlist	Waitlist	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.

Primary Outcome Measures

Name	Time	Method
Clinician-Administered PTSD Scale (CAPS)	26 Week follow up	The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome. Minimum possible score was 0, maximum possible score was 136. Higher scores indicated higher levels of symptoms.

Secondary Outcome Measures

Name	Time	Method
Perceived Stigma Measure (PSS)	26 week follow up	Stigma will be measured using a 5 question assessment scale.
Suicide Risk Assessment	26 Week follow up	Due to the nature of the questions, this is deemed to be of safety nature.
Beck Anxiety Inventory (BAI)	26 week follow up	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Side Effects Questionnaire	Treatment session 10 (week 5)	The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
BASIS-24	26 week follow up	To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Subjective Units of Distress (SUDs)	Treatment session 10 (week 5)	Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
PTSD Checklist (PCL-C)	26 week follow up	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Primary Care PTSD Screen (PC-PTSD)	26 Week follow up	The PC-PTSD is a four-item measure designed to screen for PTSD.
Beck Depression Inventory-II (BDI-II)	26 Week follow up	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Intent to Attend	2.5 weeks (or after treatment session 5)	This is a measure to assess the intent to complete study procedures.
PTSD Checklist- Civilian (PCL-C)	Screening Visit (Day 1)	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)	26 Week follow up	The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Behavior and Sympton Identification Scale (BASIS-24)	Screening Visit(Day 1)	To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.