We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01459705
First Posted: October 26, 2011
Last Update Posted: December 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Geneva Foundation
Information provided by (Responsible Party):
National Center for Telehealth and Technology
  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
Intervention Model: Parallel Assignment
Masking: Single (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) ]
    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. 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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 2.5 weeks (or after treatment session 5) ]
    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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 5 weeks (or after treatment session 10) ]
    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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 12 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.

  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 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:
  • PTSD Checklist- Civilian (PCL-C) [ Time Frame: Screening Visit (Day 1) ]
    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) ]
    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) ]
    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) ]
    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) ]
    Stigma will be measured using a 5 question assessment scale.

  • Suicide Risk Assessment [ Time Frame: Screening Visit(Day 1) ]
    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) ]
    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) ]
    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) ]
    This is a measure to assess the intent to complete study procedures.

  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 1 (week 1) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.

  • PTSD Checklist (PCL-C) [ Time Frame: 12 week follow up ]
    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 ]
    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) ]
    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 ]
    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 ]
    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) ]
    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) ]
    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 ]
    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 ]
    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) ]
    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) ]
    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 ]
    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 ]
    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) ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 5 weeks (or after treatment session 10) ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 12 week follow up ]
    Stigma will be measured using a 5 question assessment scale.

  • Perceived Stigma Measure (PSS) [ Time Frame: 26 week follow up ]
    Stigma will be measured using a 5 question assessment scale.

  • Suicide Risk Assessment [ Time Frame: 2.5 weeks (or after treatment session 5) ]
    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) ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Suicide Risk Assessment [ Time Frame: 12 Week follow up ]
    Due to the nature of the questions, this is deemed to be of safety nature.

  • Suicide Risk Assessment [ Time Frame: 26 Week follow up ]
    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) ]
    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) ]
    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 ]
    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 ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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 ]
    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 ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    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) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 3 (week 2) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 4 (week 2) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 5 (week 2.5) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 6 (week 3) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 7 (week 4) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 8 (week 4) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 9 (week 5) ]
    This is a measure to assess the intent to complete study procedures.

  • Intent to Attend [ Time Frame: Treatment session 10 (week 5) ]
    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) ]
    This is a measure to assess the intent to complete study procedures.


Enrollment: 162
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Rothbaum BO, Hodges LF. The use of virtual reality exposure in the treatment of anxiety disorders. Behav Modif. 1999 Oct;23(4):507-25. Review.
Pole N. The psychophysiology of posttraumatic stress disorder: a meta-analysis. Psychol Bull. 2007 Sep;133(5):725-46.
Jaycox LH, Foa EB, Morral AR. Influence of emotional engagement and habituation on exposure therapy for PTSD. J Consult Clin Psychol. 1998 Feb;66(1):185-92.
Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47.
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22.
Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60.
Simms LJ, Watson D, Doebbeling BN. Confirmatory factor analyses of posttraumatic stress symptoms in deployed and nondeployed veterans of the Gulf War. J Abnorm Psychol. 2002 Nov;111(4):637-47.
Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32.
Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82.
Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1.
Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22.
Koenen KC, Stellman JM, Stellman SD, Sommer JF Jr. Risk factors for course of posttraumatic stress disorder among Vietnam veterans: a 14-year follow-up of American Legionnaires. J Consult Clin Psychol. 2003 Dec;71(6):980-6.
Bryant RA, Moulds ML, Guthrie RM, Dang ST, Nixon RD. Imaginal exposure alone and imaginal exposure with cognitive restructuring in treatment of posttraumatic stress disorder. J Consult Clin Psychol. 2003 Aug;71(4):706-12.
Foa EB. Psychosocial treatment of posttraumatic stress disorder. J Clin Psychiatry. 2000;61 Suppl 5:43-8; discussion 49-51. Review.
Foa EB, Meadows EA. Psychosocial treatments for posttraumatic stress disorder: a critical review. Annu Rev Psychol. 1997;48:449-80. Review.
Carlson JG, Chemtob CM, Rusnak K, Hedlund NL, Muraoka MY. Eye movement desensitization and reprocessing (EDMR) treatment for combat-related posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):3-24.
Sherman JJ. Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials. J Trauma Stress. 1998 Jul;11(3):413-35.
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003388. Review. Update in: Cochrane Database Syst Rev. 2007;(3):CD003388.
Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79.
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35.
Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7.
Shalev AY, Sahar T, Freedman S, Peri T, Glick N, Brandes D, Orr SP, Pitman RK. A prospective study of heart rate response following trauma and the subsequent development of posttraumatic stress disorder. Arch Gen Psychiatry. 1998 Jun;55(6):553-9.
Mason J, Southwick S, Yehuda R, Wang S, Riney S, Bremner D, Johnson D, Lubin H, Blake D, Zhou G, et al. Elevation of serum free triiodothyronine, total triiodothyronine, thyroxine-binding globulin, and total thyroxine levels in combat-related posttraumatic stress disorder. Arch Gen Psychiatry. 1994 Aug;51(8):629-41.
Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. Review.
Yehuda R, Siever LJ, Teicher MH, Levengood RA, Gerber DK, Schmeidler J, Yang RK. Plasma norepinephrine and 3-methoxy-4-hydroxyphenylglycol concentrations and severity of depression in combat posttraumatic stress disorder and major depressive disorder. Biol Psychiatry. 1998 Jul 1;44(1):56-63.
Morgan CA 3rd, Grillon C, Southwick SM, Davis M, Charney DS. Exaggerated acoustic startle reflex in Gulf War veterans with posttraumatic stress disorder. Am J Psychiatry. 1996 Jan;153(1):64-8.
Shalev AY, Peri T, Orr SP, Bonne O, Pitman RK. Auditory startle responses in help-seeking trauma survivors. Psychiatry Res. 1997 Mar 3;69(1):1-7.
Malloy PF, Fairbank JA, Keane TM. Validation of a multimethod assessment of posttraumatic stress disorders in Vietnam veterans. J Consult Clin Psychol. 1983 Aug;51(4):488-94.
Orr SP, Lasko NB, Shalev AY, Pitman RK. Physiologic responses to loud tones in Vietnam veterans with posttraumatic stress disorder. J Abnorm Psychol. 1995 Feb;104(1):75-82.
Pitman RK, Orr SP, Altman B, Longpre RE, Poiré RE, Macklin ML, Michaels MJ, Steketee GS. Emotional processing and outcome of imaginal flooding therapy in Vietnam veterans with chronic posttraumatic stress disorder. Compr Psychiatry. 1996 Nov-Dec;37(6):409-18.
Keane TM, Kaloupek DG. Imaginal flooding in the treatment of a posttraumatic stress disorder. J Consult Clin Psychol. 1982 Feb;50(1):138-40.
Cardeña E, Spiegel D. Dissociative reactions to the San Francisco Bay Area earthquake of 1989. Am J Psychiatry. 1993 Mar;150(3):474-8.
Koopman C, Classen C, Spiegel D. Predictors of posttraumatic stress symptoms among survivors of the Oakland/Berkeley, Calif., firestorm. Am J Psychiatry. 1994 Jun;151(6):888-94.
Reger GM, McGee JS, van der Zaag C, Thiebaux M, Galen Buckwalter JG, Rizzo AA. A 3D virtual environment rod and frame test: the reliability and validity of four traditional scoring methods for older adults. J Clin Exp Neuropsychol. 2003 Dec;25(8):1169-77.
Rothbaum BO, Hodges L, Watson BA, Kessler CD, Opdyke D. Virtual reality exposure therapy in the treatment of fear of flying: a case report. Behav Res Ther. 1996 May-Jun;34(5-6):477-81.
Rothbaum BO, Hodges L, Smith S, Lee JH, Price L. A controlled study of virtual reality exposure therapy for the fear of flying. J Consult Clin Psychol. 2000 Dec;68(6):1020-6.
Rothbaum BO, Hodges L, Anderson PL, Price L, Smith S. Twelve-month follow-up of virtual reality and standard exposure therapies for the fear of flying. J Consult Clin Psychol. 2002 Apr;70(2):428-32.
Rothbaum BO, Hodges LF, Kooper R, Opdyke D, Williford JS, North M. Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia. Am J Psychiatry. 1995 Apr;152(4):626-8.
Emmelkamp PM, Krijn M, Hulsbosch AM, de Vries S, Schuemie MJ, van der Mast CA. Virtual reality treatment versus exposure in vivo: a comparative evaluation in acrophobia. Behav Res Ther. 2002 May;40(5):509-16.
Botella C, Baños RM, Perpiñá C, Villa H, Alcañiz M, Rey A. Virtual reality treatment of claustrophobia: a case report. Behav Res Ther. 1998 Feb;36(2):239-46.
Carlin AS, Hoffman HG, Weghorst S. Virtual reality and tactile augmentation in the treatment of spider phobia: a case report. Behav Res Ther. 1997 Feb;35(2):153-8.
Garcia-Palacios A, Hoffman H, Carlin A, Furness TA 3rd, Botella C. Virtual reality in the treatment of spider phobia: a controlled study. Behav Res Ther. 2002 Sep;40(9):983-93.
Rothbaum BO, Anderson P, Zimand E, Hodges L, Lang D, Wilson J. Virtual reality exposure therapy and standard (in vivo) exposure therapy in the treatment of fear of flying. Behav Ther. 2006 Mar;37(1):80-90. Epub 2006 Feb 24.
Botella C, Perpiñá C, Baños RM, García-Palacios A. Virtual reality: a new clinical setting lab. Stud Health Technol Inform. 1998;58:73-81. Review.
Gershon J, Zimand E, Lemos R, Rothbaum BO, Hodges L. Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Cyberpsychol Behav. 2003 Dec;6(6):657-61.
Rothbaum BO, Hodges L, Alarcon R, Ready D, Shahar F, Graap K, Pair J, Hebert P, Gotz D, Wills B, Baltzell D. Virtual reality exposure therapy for PTSD Vietnam Veterans: a case study. J Trauma Stress. 1999 Apr;12(2):263-71.
Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. Review. Erratum in: Am J Psychiatry. 2005 Apr;162(4):832. Am J Psychiatry. 2006 Feb;163(2):330.
Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. Review.
Aziz MA, Kenford S. Comparability of telephone and face-to-face interviews in assessing patients with posttraumatic stress disorder. J Psychiatr Pract. 2004 Sep;10(5):307-13.
Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73.
Bolton EE, Gray MJ, Litz BT. A cross-lagged analysis of the relationship between symptoms of PTSD and retrospective reports of exposure. J Anxiety Disord. 2006;20(7):877-95. Epub 2006 Mar 10.
Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97.
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7.
Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82.
Pyne JM, Kuc EJ, Schroeder PJ, Fortney JC, Edlund M, Sullivan G. Relationship between perceived stigma and depression severity. J Nerv Ment Dis. 2004 Apr;192(4):278-83.
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207.
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.
Foa EB, Hearst-Ikeda D. Emotional Dissociation in Response to Trauma: An Information-Processing Approach. In: Michelson LK, Ray WJ, eds. Handbook of Dissociation: Theoretical and Clinical Perspectives. New York: Plenum Press; 1996:207-222.
Lating JM, Everly GS, Jr. Psychophysiological assessment of PTSD. In: Everly, GS, Jr., Lating LM, eds. Psychotraumatology: Key papers and core concepts in post-traumatic stress. New York: Plenum Press; 1995:129-145.
Boudewyns P, Hyer L. Physiological response to combat memories and preliminary treatment outcome in Vietnam veteran PTSD patients treated with direct therapeutic exposure. Behavior Therapy. 1990;21 (1):63-87.
Britt TW. The stigma of psychological problems in a work environment: Evidence from the screening of Service Members returning from Bosnia. J of Applied Psych. 2000;30(8):1599-1618
Foa EB, Riggs DS, Massie ED, Yarczower M. The impact of fear activation and anger on the efficacy of exposure treatment for PTSD. Behavior Therapy. 1995;26:487-499.
Rizzo AA, Buckwalter JG, van der Zaag C. Virtual Environment Applications for Neuropsychological Assessment and Rehabilitation. In: Stanney K, ed. Handbook of Virtual Environments. New York: L.A. Earlbaum; 2002:1027-1064.
Smith SG, Rothbaum BO, Hodges L. Treatment of fear of flying using virtual reality exposure therapy: A single case study. The Behavior Therapist. 1999;22(8):154-158,160.
Anderson P, Rothbaum BO, Hodges LF. Virtual reality exposure in the treatment of social anxiety: Two case reports. Cognitive and Behavioral Practice. 2003;10:240-247.
Glantz K, Rizzo AA, Graap K. Virtual reality for psychotherapy: Current reality and future possibilities. Psychotherapy: Theory, Research, Practice, Training. 2003;40(1/2):55-67.
Rizzo AA, Schultheis MT, Kerns K, Mateer C. Analysis of assets for virtual applications in neuropsychology. Neuropsychological Rehabilitation. 2004;14(1/2):207-239.
Rizzo AA, Rothbaum BO, Graap K. Virtual Reality Applications for Combat-Related Posttraumatic Stress Disorder. In: Figley CR, Nash WP, eds. For Those Who Bore the Battle: Combat Stress Injury Theory, Research, and Management. New York: Taylor and Francis Books; 2006.
Rothbaum BO, Ruef AM, Litz BT, Han H, Hodges L. Virtual reality exposure therapy of combat-related PTSD: A case study using psychophysiological indicators of outcome. Journal of Cognitive Psychotherapy. 2003;17(2):163-177.
Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum Associates; 1988.
Cohen J, Cohen P. Applied Multiple Regression/Correlation Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum; 1983.
Foa EB, Hembree E, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences. New York: Oxford University Press; 2007.
Nishith P, Resick PA. Adherence and competence rating scales for prolonged exposure treatment: Unpublished Rating Scale, University of Missouri-St. Louis; 1994.
Ajzen I. From intentions to actions: A theory of planned behavior. In: Kuhl J, Beckman, J, eds. Action-Control: From Cognition to Behavior. Heidelberg: Springer; 1985:11-39.
Komiya N, Good GE, Sherrod NB. Emotional openness as a predictor of college students' attitudes toward seeking psychological help. J Counsel Psychol. 2000;47(1):138-143.
Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. International Journal of Aviation Psychology. 1993;3(3):203-220.

Responsible Party: National Center for Telehealth and Technology
ClinicalTrials.gov Identifier: NCT01459705     History of Changes
Other Study ID Numbers: 112226
W81XWH-11-2-0007 ( Other Grant/Funding Number: USMRMC )
First Submitted: October 24, 2011
First Posted: October 26, 2011
Results First Submitted: October 9, 2015
Results First Posted: December 14, 2015
Last Update Posted: December 14, 2015
Last Verified: November 2015

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders


To Top