VRPE Extension: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

• Sponsor: National Center for Telehealth and Technology (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT01459705
• Collaborator: The Geneva Foundation (Other)
• Enrollment: 162
• Location: 1
• Arms: 3
• Duration (Months): 31
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Disorders; Post-Traumatic Stress Disorder	Behavioral: Prolonged Exposure Therapy (PE); Behavioral: Virtual Reality Exposure Therapy (VRET); Behavioral: Waitlist	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 162 participants
• 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)
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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

Outcome Measures

Primary Outcome Measures

1. Clinician-Administered PTSD Scale (CAPS) [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.

2. Clinician-Administered PTSD Scale (CAPS) [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.

3. Clinician-Administered PTSD Scale (CAPS) [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.

4. Clinician-Administered PTSD Scale (CAPS) [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.

5. Clinician-Administered PTSD Scale (CAPS) [26 Week follow up]

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

Secondary Outcome Measures

1. PTSD Checklist- Civilian (PCL-C) [Screening Visit (Day 1)]

   The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

2. Primary Care PTSD Screen (PC-PTSD) [Screening Visit (Day 1)]

   The PC-PTSD is a four-item measure designed to screen for PTSD.

3. Beck Depression Inventory-II (BDI-II) [Screening Visit(Day 1)]

   This self report measure of depression contains 21 items that are rated on a 4 point scale.

4. Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [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.

5. Perceived Stigma Measure (PSS) [Screening Visit(Day 1)]

   Stigma will be measured using a 5 question assessment scale.

6. Suicide Risk Assessment [Screening Visit(Day 1)]

   Due to the nature of the questions, this is deemed to be of safety nature.

7. Beck Anxiety Inventory (BAI) [Screening Visit(Day 1)]

   The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

8. Behavior and Sympton Identification Scale (BASIS-24) [Screening Visit(Day 1)]

   To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.

9. Intent to Attend [Screening Visit (Day 1)]

   This is a measure to assess the intent to complete study procedures.

10. Subjective Units of Distress (SUDs) [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.

11. Side Effects Questionnaire [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.

12. BASIS-24 [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.

13. Intent to Attend [Treatment session 1 (week 1)]

    This is a measure to assess the intent to complete study procedures.

14. PTSD Checklist (PCL-C) [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.

15. PTSD Checklist (PCL-C) [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.

16. Primary Care PTSD Screen (PC-PTSD) [2.5 weeks (or after treatment session 5)]

    The PC-PTSD is a four-item measure designed to screen for PTSD.

17. PTSD Checklist (PCL-C) [12 week follow up]

    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

18. PTSD Checklist (PCL-C) [26 week follow up]

    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.

19. Primary Care PTSD Screen (PC-PTSD) [5 weeks (or after treatment session 10)]

    The PC-PTSD is a four-item measure designed to screen for PTSD.

20. Primary Care PTSD Screen (PC-PTSD) [12 Week follow up]

    The PC-PTSD is a four-item measure designed to screen for PTSD.

21. Primary Care PTSD Screen (PC-PTSD) [26 Week follow up]

    The PC-PTSD is a four-item measure designed to screen for PTSD.

22. Beck Depression Inventory-II (BDI-II) [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.

23. Beck Depression Inventory-II (BDI-II) [5 weeks (or after treatment session 10)]

    This self report measure of depression contains 21 items that are rated on a 4 point scale.

24. Beck Depression Inventory-II (BDI-II) [12 Week follow up]

    This self report measure of depression contains 21 items that are rated on a 4 point scale.

25. Beck Depression Inventory-II (BDI-II) [26 Week follow up]

    This self report measure of depression contains 21 items that are rated on a 4 point scale.

26. Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [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.

27. Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [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.

28. Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [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.

29. Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [26 Week follow up]

    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.

30. Perceived Stigma Measure (PSS) [2.5 weeks (or after treatment session 5)]

    Stigma will be measured using a 5 question assessment scale.

31. Perceived Stigma Measure (PSS) [5 weeks (or after treatment session 10)]

    Stigma will be measured using a 5 question assessment scale.

32. Perceived Stigma Measure (PSS) [12 week follow up]

    Stigma will be measured using a 5 question assessment scale.

33. Perceived Stigma Measure (PSS) [26 week follow up]

    Stigma will be measured using a 5 question assessment scale.

34. Suicide Risk Assessment [2.5 weeks (or after treatment session 5)]

    Due to the nature of the questions, this is deemed to be of safety nature.

35. Suicide Risk Assessment [5 weeks (or after treatment session 10)]

    Due to the nature of the questions, this is deemed to be of safety nature.

36. Suicide Risk Assessment [12 Week follow up]

    Due to the nature of the questions, this is deemed to be of safety nature.

37. Suicide Risk Assessment [26 Week follow up]

    Due to the nature of the questions, this is deemed to be of safety nature.

38. Beck Anxiety Inventory (BAI) [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.

39. Beck Anxiety Inventory (BAI) [5 weeks (or after treatment session 10)]

    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

40. Beck Anxiety Inventory (BAI) [12 week follow up]

    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

41. Beck Anxiety Inventory (BAI) [26 week follow up]

    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.

42. BASIS-24 [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.

43. BASIS-24 [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.

44. BASIS-24 [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.

45. BASIS-24 [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.

46. BASIS-24 [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.

47. BASIS-24 [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.

48. BASIS-24 [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.

49. BASIS-24 [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.

50. BASIS-24 [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.

51. BASIS-24 [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.

52. BASIS-24 [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.

53. BASIS-24 [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.

54. BASIS-24 [26 week follow up]

    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.

55. Subjective Units of Distress (SUDs) [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.

56. Subjective Units of Distress (SUDs) [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.

57. Subjective Units of Distress (SUDs) [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.

58. Subjective Units of Distress (SUDs) [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.

59. Subjective Units of Distress (SUDs) [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.

60. Subjective Units of Distress (SUDs) [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.

61. Subjective Units of Distress (SUDs) [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.

62. Subjective Units of Distress (SUDs) [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.

63. Subjective Units of Distress (SUDs) [Treatment session 10 (week 5)]

    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.

64. Side Effects Questionnaire [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.

65. Side Effects Questionnaire [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.

66. Side Effects Questionnaire [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.

67. Side Effects Questionnaire [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.

68. Side Effects Questionnaire [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.

69. Side Effects Questionnaire [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.

70. Side Effects Questionnaire [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.

71. Side Effects Questionnaire [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.

72. Side Effects Questionnaire [Treatment session 10 (week 5)]

    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.

73. Intent to Attend [Treatment session 2 (week 1)]

    This is a measure to assess the intent to complete study procedures.

74. Intent to Attend [Treatment session 3 (week 2)]

    This is a measure to assess the intent to complete study procedures.

75. Intent to Attend [Treatment session 4 (week 2)]

    This is a measure to assess the intent to complete study procedures.

76. Intent to Attend [Treatment session 5 (week 2.5)]

    This is a measure to assess the intent to complete study procedures.

77. Intent to Attend [Treatment session 6 (week 3)]

    This is a measure to assess the intent to complete study procedures.

78. Intent to Attend [Treatment session 7 (week 4)]

    This is a measure to assess the intent to complete study procedures.

79. Intent to Attend [Treatment session 8 (week 4)]

    This is a measure to assess the intent to complete study procedures.

80. Intent to Attend [Treatment session 9 (week 5)]

    This is a measure to assess the intent to complete study procedures.

81. Intent to Attend [Treatment session 10 (week 5)]

    This is a measure to assess the intent to complete study procedures.

82. Intent to Attend [2.5 weeks (or after treatment session 5)]

    This is a measure to assess the intent to complete study procedures.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

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• 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.
• 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.
• Nishith P, Resick PA. Adherence and competence rating scales for prolonged exposure treatment: Unpublished Rating Scale, University of Missouri-St. Louis; 1994.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Rizzo AA, Schultheis MT, Kerns K, Mateer C. Analysis of assets for virtual applications in neuropsychology. Neuropsychological Rehabilitation. 2004;14(1/2):207-239.
• 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.
• 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.
• 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 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, 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 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.
• 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.
• 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.
• 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.
• 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.
• Sherman JJ. Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials. J Trauma Stress. 1998 Jul;11(3):413-35.
• 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.
• 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.
• Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. Review.

• Responsible Party: National Center for Telehealth and Technology
• ClinicalTrials.gov Identifier: NCT01459705
• Other Study ID Numbers: 112226; W81XWH-11-2-0007
• First Posted: Oct 26, 2011
• Last Update Posted: Dec 14, 2015
• Last Verified: Nov 1, 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

Study Results

Participant Flow

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)	Waitlist
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Period Title: Overall Study
STARTED	54	54	54
COMPLETED	32	30	47
NOT COMPLETED	22	24	7

Baseline Characteristics

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)	Waitlist	Total
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation	Total of all reporting groups
Overall Participants	54	54	54	162
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	54 100%	54 100%	54 100%	162 100%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.89 (7.09)	29.52 (6.47)	30.39 (6.45)	30.27 (6.66)
Sex: Female, Male (Count of Participants)
Female	3 5.6%	2 3.7%	1 1.9%	6 3.7%
Male	51 94.4%	52 96.3%	53 98.1%	156 96.3%
Region of Enrollment (participants) [Number]
United States	54 100%	54 100%	54 100%	162 100%

Outcome Measures

1. Primary Outcome

Title	Clinician-Administered PTSD Scale (CAPS)
Description	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.
Time Frame	Screening Visit (Day 1)

Outcome Measure Data

Analysis Population Description

Baseline scores on the CAPS-W (last week reference)

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)	Waitlist
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Measure Participants	54	54	54
Mean (Standard Deviation) [units on scale]	78.28 (16.35)	80.44 (16.23)	78.89 (16.87)

2. Primary Outcome

Title	Clinician-Administered PTSD Scale (CAPS)
Description	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.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

Participants who provided data at mid treatment

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)	Waitlist
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Measure Participants	39	36	52
Mean (Standard Deviation) [units on a scale]	65.03 (29.19)	71.19 (23.27)	74.73 (21.78)

3. Primary Outcome

Title	Clinician-Administered PTSD Scale (CAPS)
Description	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.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

Participants who provided outcome data at post treatment

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)	Waitlist
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Measure Participants	32	30	47
Mean (Standard Deviation) [units on a scale]	44.28 (33.73)	57.07 (32.32)	68.06 (24.27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prolonged Exposure Therapy (PE), Waitlist
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-22.34
	Confidence Interval	(1-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 4.69
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Virtual Reality Exposure Therapy (VRET), Waitlist
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-13.30
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 4.77
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	9.04
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.11
	Estimation Comments

4. Primary Outcome

Title	Clinician-Administered PTSD Scale (CAPS)
Description	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.
Time Frame	12 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.
Measure Participants	27	26
Mean (Standard Deviation) [units on a scale]	36.63 (31.80)	55.88 (31.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	15.07
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Deviation; Value: 6.03
	Estimation Comments

5. Primary Outcome

Title	Clinician-Administered PTSD Scale (CAPS)
Description	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.
Time Frame	26 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Prolonged Exposure Therapy (PE)	Virtual Reality Exposure Therapy (VRET)
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	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. 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.
Measure Participants	24	17
Mean (Standard Deviation) [units on a scale]	38.33 (28.49)	54.47 (28.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET)
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	13.91
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 6.70
	Estimation Comments

6. Secondary Outcome

Title	PTSD Checklist- Civilian (PCL-C)
Description	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame	Screening Visit (Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	Primary Care PTSD Screen (PC-PTSD)
Description	The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame	Screening Visit (Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Description	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.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Perceived Stigma Measure (PSS)
Description	Stigma will be measured using a 5 question assessment scale.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Suicide Risk Assessment
Description	Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Secondary Outcome

Title	Behavior and Sympton Identification Scale (BASIS-24)
Description	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.
Time Frame	Screening Visit(Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

14. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Screening Visit (Day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

15. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 1 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

16. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 1(week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

17. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 1 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

18. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 1 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

19. Secondary Outcome

Title	PTSD Checklist (PCL-C)
Description	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

20. Secondary Outcome

Title	PTSD Checklist (PCL-C)
Description	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

21. Secondary Outcome

Title	Primary Care PTSD Screen (PC-PTSD)
Description	The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

22. Secondary Outcome

Title	PTSD Checklist (PCL-C)
Description	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame	12 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

23. Secondary Outcome

Title	PTSD Checklist (PCL-C)
Description	The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Time Frame	26 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

24. Secondary Outcome

Title	Primary Care PTSD Screen (PC-PTSD)
Description	The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

25. Secondary Outcome

Title	Primary Care PTSD Screen (PC-PTSD)
Description	The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame	12 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

26. Secondary Outcome

Title	Primary Care PTSD Screen (PC-PTSD)
Description	The PC-PTSD is a four-item measure designed to screen for PTSD.
Time Frame	26 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

27. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

28. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

29. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame	12 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

30. Secondary Outcome

Title	Beck Depression Inventory-II (BDI-II)
Description	This self report measure of depression contains 21 items that are rated on a 4 point scale.
Time Frame	26 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

31. Secondary Outcome

Title	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Description	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.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

32. Secondary Outcome

Title	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Description	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.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

33. Secondary Outcome

Title	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Description	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.
Time Frame	12 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

34. Secondary Outcome

Title	Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Description	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.
Time Frame	26 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

35. Secondary Outcome

Title	Perceived Stigma Measure (PSS)
Description	Stigma will be measured using a 5 question assessment scale.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

36. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

37. Secondary Outcome

Title	Perceived Stigma Measure (PSS)
Description	Stigma will be measured using a 5 question assessment scale.
Time Frame	12 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

38. Secondary Outcome

Title	Perceived Stigma Measure (PSS)
Description	Stigma will be measured using a 5 question assessment scale.
Time Frame	26 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

39. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

40. Secondary Outcome

Title	Suicide Risk Assessment
Description	Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

41. Secondary Outcome

Title	Suicide Risk Assessment
Description	Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame	12 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

42. Secondary Outcome

Title	Suicide Risk Assessment
Description	Due to the nature of the questions, this is deemed to be of safety nature.
Time Frame	26 Week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

43. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

44. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

45. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame	12 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

46. Secondary Outcome

Title	Beck Anxiety Inventory (BAI)
Description	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Time Frame	26 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

47. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 2 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

48. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 3 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

49. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 4 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

50. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 5 (week 2.5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

51. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 6 (week 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

52. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 7 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

53. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 8 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

54. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 9 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

55. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	Treatment session 10 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

56. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	5 weeks (or after treatment session 10)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

57. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

58. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	12 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

59. Secondary Outcome

Title	BASIS-24
Description	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.
Time Frame	26 week follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

60. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 2 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

61. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 3 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

62. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 4 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

63. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 5 (week 2.5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

64. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 6 (week 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

65. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 7 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

66. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 8 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

67. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 9 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

68. Secondary Outcome

Title	Subjective Units of Distress (SUDs)
Description	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.
Time Frame	Treatment session 10 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

69. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 2 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

70. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 3 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

71. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 4 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

72. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 5 (week 2.5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

73. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 6 (week 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

74. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 7 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

75. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 8 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

76. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 9 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

77. Secondary Outcome

Title	Side Effects Questionnaire
Description	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.
Time Frame	Treatment session 10 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

78. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 2 (week 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

79. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 3 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

80. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 4 (week 2)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

81. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 5 (week 2.5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

82. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 6 (week 3)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

83. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 7 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

84. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 8 (week 4)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

85. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 9 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

86. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	Treatment session 10 (week 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

87. Secondary Outcome

Title	Intent to Attend
Description	This is a measure to assess the intent to complete study procedures.
Time Frame	2.5 weeks (or after treatment session 5)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months. From time of baseline visit to final follow up visit
Arm/Group Title	Prolonged Exposure Therapy (PE)		Virtual Reality Exposure Therapy (VRET)		Waitlist
Arm/Group Description	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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.		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. 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.		The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
All Cause Mortality
	Prolonged Exposure Therapy (PE)		Virtual Reality Exposure Therapy (VRET)		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Prolonged Exposure Therapy (PE)		Virtual Reality Exposure Therapy (VRET)		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		3/54 (5.6%)		0/54 (0%)
Psychiatric disorders
Hospitalization - psychiatric	0/54 (0%)	0	3/54 (5.6%)	3	0/54 (0%)	0
Other (Not Including Serious) Adverse Events
	Prolonged Exposure Therapy (PE)		Virtual Reality Exposure Therapy (VRET)		Waitlist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/54 (22.2%)		15/54 (27.8%)		0/54 (0%)
Cardiac disorders
chest pain	1/54 (1.9%)	1	1/54 (1.9%)	2	0/54 (0%)	0
Gastrointestinal disorders
Nausea	5/54 (9.3%)	6	3/54 (5.6%)	4	0/54 (0%)	0
intermittent stomach ache and diarrhea	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
General disorders
Headache	7/54 (13%)	9	4/54 (7.4%)	8	0/54 (0%)	0
dizziness	2/54 (3.7%)	2	1/54 (1.9%)	1	0/54 (0%)	0
flu like symptoms	0/54 (0%)	0	1/54 (1.9%)	2	0/54 (0%)	0
cold symptoms	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
syncopal episode	1/54 (1.9%)	1	0/54 (0%)	0	0/54 (0%)	0
alcohol consumption	2/54 (3.7%)	2	0/54 (0%)	0	0/54 (0%)	0
Musculoskeletal and connective tissue disorders
Dislocated Shoulder	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
exacerbation of neck and back pain	0/54 (0%)	0	1/54 (1.9%)	2	0/54 (0%)	0
Psychiatric disorders
increase in flashbacks	1/54 (1.9%)	3	0/54 (0%)	0	0/54 (0%)	0
homicidal ideation	0/54 (0%)	0	2/54 (3.7%)	2	0/54 (0%)	0
increased intrusive memories	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
increased irritability	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
increased anxiety around weapons	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
self percieved persecution	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0
Respiratory, thoracic and mediastinal disorders
Shortness of Breath	1/54 (1.9%)	1	0/54 (0%)	0	0/54 (0%)	0
Skin and subcutaneous tissue disorders
Eczema	0/54 (0%)	0	1/54 (1.9%)	2	0/54 (0%)	0
rash from ECG lead	0/54 (0%)	0	1/54 (1.9%)	1	0/54 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.