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

This study has been completed.
Sponsor:
Collaborator:
The Geneva Foundation
Information provided by (Responsible Party):
National Center for Telehealth and Technology
ClinicalTrials.gov Identifier:
NCT01459705
First received: October 24, 2011
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Stress Disorders
Post-Traumatic Stress Disorder
Behavioral: Prolonged Exposure Therapy (PE)
Behavioral: Virtual Reality Exposure Therapy (VRET)
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)

Resource links provided by NLM:


Further study details as provided by National Center for Telehealth and Technology:

Primary Outcome Measures:
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • PTSD Checklist- Civilian (PCL-C) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.

  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    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.

  • Perceived Stigma Measure (PSS) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.

  • Suicide Risk Assessment [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Beck Anxiety Inventory (BAI) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

  • Behavior and Sympton Identification Scale (BASIS-24) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: Yes ]
    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.

  • Intent to Attend [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: No ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 1(week 1) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: Yes ]
    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.

  • Intent to attend [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • PTSD Checklist (PCL-C) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

  • PTSD Checklist (PCL-C) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • PTSD Checklist (PCL-C) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

  • PTSD Checklist (PCL-C) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    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) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.

  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.

  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    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.

  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    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.

  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    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.

  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    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.

  • Perceived Stigma Measure (PSS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.

  • Suicide Risk Assessment [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Suicide Risk Assessment [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Suicide Risk Assessment [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Suicide Risk Assessment [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

  • Beck Anxiety Inventory (BAI) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

  • BASIS-24 [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: 12 week follow up ] [ Designated as safety issue: Yes ]
    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.

  • BASIS-24 [ Time Frame: 26 week follow up ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: No ]
    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.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: No ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: Yes ]
    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.

  • Side Effects Questionnaire [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: Yes ]
    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.

  • Intent to attend [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to attend [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.


Enrollment: 296
Study Start Date: October 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Prolonged Exposure Therapy (PE)
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
Other Name: PE
Experimental: 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.
Behavioral: Virtual Reality Exposure Therapy (VRET)
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
Other Names:
  • VRE
  • VRET
Placebo Comparator: Waitlist
The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Behavioral: Waitlist
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Other Names:
  • WL
  • Waitlist Control Group

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459705

Locations
United States, North Carolina
Womack Clinical Psychology Service
Fort Bragg, North Carolina, United States, 28307
Sponsors and Collaborators
National Center for Telehealth and Technology
The Geneva Foundation
Investigators
Principal Investigator: Gregory A Gahm, PhD DCoE- National Center for Telehealth and Technology
Principal Investigator: Greg Reger, PhD DCoE - National Center for Telehealth and Technology
  More Information

Publications:
Bryant RA. Cognitive behavior therapy of violence-related posttraumatic stress disorder. Aggression and Violent Behavior. 2000;5:79-97.
Foa EB,Steketee GS, Rothbaum BO. Behavioral/cognitive conceptualizations of post-traumatic stress disorder. Behavior Therapy. 1989;20:155-176.
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Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01459705     History of Changes
Other Study ID Numbers: 112226, W81XWH-11-2-0007
Study First Received: October 24, 2011
Last Updated: May 22, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Center for Telehealth and Technology:
Combat Disorders
Exposure Therapy
Army Personnel

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014