Clinical trial NCT01459705: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure
Official title: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders
Post-Traumatic Stress Disorder
Keywords: Combat Disorders
Exposure Therapy
Army Personnel
Lead sponsor: National Center for Telehealth and Technology
Sponsor class: FED
Collaborators: name: The Geneva Foundation
First posted: 2011-10-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: Screening Visit (Day 1)
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 5 weeks (or after treatment session 10)
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 12 week follow up
measure: Clinician-Administered PTSD Scale (CAPS)
timeFrame: 26 Week follow up
Secondary outcomes:
measure: PTSD Checklist- Civilian (PCL-C)
timeFrame: Screening Visit (Day 1)
measure: Primary Care PTSD Screen (PC-PTSD)
timeFrame: Screening Visit (Day 1)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: Screening Visit(Day 1)
measure: Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
timeFrame: Screening Visit(Day 1)
measure: Perceived Stigma Measure (PSS)
timeFrame: Screening Visit(Day 1)
measure: Suicide Risk Assessment
timeFrame: Screening Visit(Day 1)
measure: Beck Anxiety Inventory (BAI)
timeFrame: Screening Visit(Day 1)
measure: Behavior and Sympton Identification Scale (BASIS-24)
timeFrame: Screening Visit(Day 1)
measure: Intent to Attend
timeFrame: Screening Visit (Day 1)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 1 (week 1)
measure: Side Effects Questionnaire
timeFrame: Treatment session 1(week 1)
measure: BASIS-24
timeFrame: Treatment session 1 (week 1)
measure: Intent to Attend
timeFrame: Treatment session 1 (week 1)
measure: PTSD Checklist (PCL-C)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: PTSD Checklist (PCL-C)
timeFrame: 5 weeks (or after treatment session 10)
measure: Primary Care PTSD Screen (PC-PTSD)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: PTSD Checklist (PCL-C)
timeFrame: 12 week follow up
measure: PTSD Checklist (PCL-C)
timeFrame: 26 week follow up
measure: Primary Care PTSD Screen (PC-PTSD)
timeFrame: 5 weeks (or after treatment session 10)
measure: Primary Care PTSD Screen (PC-PTSD)
timeFrame: 12 Week follow up
measure: Primary Care PTSD Screen (PC-PTSD)
timeFrame: 26 Week follow up
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 5 weeks (or after treatment session 10)
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 12 Week follow up
measure: Beck Depression Inventory-II (BDI-II)
timeFrame: 26 Week follow up
measure: Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
timeFrame: 5 weeks (or after treatment session 10)
measure: Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
timeFrame: 12 Week follow up
measure: Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
timeFrame: 26 Week follow up
measure: Perceived Stigma Measure (PSS)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Perceived Stigma Measure (PSS)
timeFrame: 5 weeks (or after treatment session 10)
measure: Perceived Stigma Measure (PSS)
timeFrame: 12 week follow up
measure: Perceived Stigma Measure (PSS)
timeFrame: 26 week follow up
measure: Suicide Risk Assessment
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Suicide Risk Assessment
timeFrame: 5 weeks (or after treatment session 10)
measure: Suicide Risk Assessment
timeFrame: 12 Week follow up
measure: Suicide Risk Assessment
timeFrame: 26 Week follow up
measure: Beck Anxiety Inventory (BAI)
timeFrame: 2.5 weeks (or after treatment session 5)
measure: Beck Anxiety Inventory (BAI)
timeFrame: 5 weeks (or after treatment session 10)
measure: Beck Anxiety Inventory (BAI)
timeFrame: 12 week follow up
measure: Beck Anxiety Inventory (BAI)
timeFrame: 26 week follow up
measure: BASIS-24
timeFrame: Treatment session 2 (week 1)
measure: BASIS-24
timeFrame: Treatment session 3 (week 2)
measure: BASIS-24
timeFrame: Treatment session 4 (week 2)
measure: BASIS-24
timeFrame: Treatment session 5 (week 2.5)
measure: BASIS-24
timeFrame: Treatment session 6 (week 3)
measure: BASIS-24
timeFrame: Treatment session 7 (week 4)
measure: BASIS-24
timeFrame: Treatment session 8 (week 4)
measure: BASIS-24
timeFrame: Treatment session 9 (week 5)
measure: BASIS-24
timeFrame: Treatment session 10 (week 5)
measure: BASIS-24
timeFrame: 5 weeks (or after treatment session 10)
measure: BASIS-24
timeFrame: 2.5 weeks (or after treatment session 5)
measure: BASIS-24
timeFrame: 12 week follow up
measure: BASIS-24
timeFrame: 26 week follow up
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 2 (week 1)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 3 (week 2)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 4 (week 2)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 5 (week 2.5)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 6 (week 3)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 7 (week 4)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 8 (week 4)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 9 (week 5)
measure: Subjective Units of Distress (SUDs)
timeFrame: Treatment session 10 (week 5)
measure: Side Effects Questionnaire
timeFrame: Treatment session 2 (week 1)
measure: Side Effects Questionnaire
timeFrame: Treatment session 3 (week 2)
measure: Side Effects Questionnaire
timeFrame: Treatment session 4 (week 2)
measure: Side Effects Questionnaire
timeFrame: Treatment session 5 (week 2.5)
measure: Side Effects Questionnaire
timeFrame: Treatment session 6 (week 3)
measure: Side Effects Questionnaire
timeFrame: Treatment session 7 (week 4)
measure: Side Effects Questionnaire
timeFrame: Treatment session 8 (week 4)
measure: Side Effects Questionnaire
timeFrame: Treatment session 9 (week 5)
measure: Side Effects Questionnaire
timeFrame: Treatment session 10 (week 5)
measure: Intent to Attend
timeFrame: Treatment session 2 (week 1)
measure: Intent to Attend
timeFrame: Treatment session 3 (week 2)
measure: Intent to Attend
timeFrame: Treatment session 4 (week 2)
measure: Intent to Attend
timeFrame: Treatment session 5 (week 2.5)
measure: Intent to Attend
timeFrame: Treatment session 6 (week 3)
measure: Intent to Attend
timeFrame: Treatment session 7 (week 4)
measure: Intent to Attend
timeFrame: Treatment session 8 (week 4)
measure: Intent to Attend
timeFrame: Treatment session 9 (week 5)
measure: Intent to Attend
timeFrame: Treatment session 10 (week 5)
measure: Intent to Attend
timeFrame: 2.5 weeks (or after treatment session 5)
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Clinical Psychology Service
state: North Carolina
Study officials:
affiliation: DCoE- National Center for Telehealth and Technology
name: Gregory A Gahm, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DCoE - National Center for Telehealth and Technology
name: Greg Reger, PhD
role: PRINCIPAL_INVESTIGATOR
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