Clinical trial NCT01193725: Exposure Therapy for Active Duty Soldiers With Post Traumatic Stress Disorder
Official title: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Post Traumatic
Keywords: Combat Disorders
Exposure Therapy
Army Personnel
Lead sponsor: National Center for Telehealth and Technology
Sponsor class: FED
Collaborators: name: University of Southern California
First posted: 2010-09-02
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 realty 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 hypotheses 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 OIF/OEF
* non sexually based deployment related trauma
* three or more months since index trauma
* stable on psychotropic medications 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

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 (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: BASIS-24
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: 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: 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: 2.5 weeks (or after treatment session 5)
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 1(week 1)
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: 2.5 weeks (or after treatment session 5)
measure: BASIS-24
timeFrame: 5 weeks (or after treatment session 10)
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)
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: National Center for Telehealth and Technology
state: Washington
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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