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Completed

NCT Number: NCT01459705

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

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.

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Key information

Conditions

Stress Disorders Combat Disorders Mental Disorders Post-traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Womack Clinical Psychology Service

Fort Bragg, North Carolina, 28307, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prolonged Exposure Therapy (PE)

Behavioral

Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.

Other names: PE

Virtual reality exposure therapy (VRET)

Behavioral

Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.

Other names: VRE, VRET

Waitlist

Behavioral

This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation

Other names: WL, Waitlist Control Group

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Perceived Stigma Measure (PSS)

    Time frame: Screening Visit(Day 1)

    Stigma will be measured using a 5 question assessment scale.

  6. Suicide Risk Assessment

    Time frame: Screening Visit(Day 1)

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

  7. 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.

  8. 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.

  9. Intent to Attend

    Time frame: Screening Visit (Day 1)

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

  10. 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.

  11. 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.

  12. 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.

  13. Intent to Attend

    Time frame: Treatment session 1 (week 1)

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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 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.

  27. 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.

  28. 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.

  29. 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.

  30. Perceived Stigma Measure (PSS)

    Time frame: 2.5 weeks (or after treatment session 5)

    Stigma will be measured using a 5 question assessment scale.

  31. Perceived Stigma Measure (PSS)

    Time frame: 5 weeks (or after treatment session 10)

    Stigma will be measured using a 5 question assessment scale.

  32. Perceived Stigma Measure (PSS)

    Time frame: 12 week follow up

    Stigma will be measured using a 5 question assessment scale.

  33. Perceived Stigma Measure (PSS)

    Time frame: 26 week follow up

    Stigma will be measured using a 5 question assessment scale.

  34. 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.

  35. 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.

  36. Suicide Risk Assessment

    Time frame: 12 Week follow up

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

  37. Suicide Risk Assessment

    Time frame: 26 Week follow up

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

  38. 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.

  39. 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.

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

  45. 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.

  46. 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.

  47. 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.

  48. 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.

  49. 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.

  50. 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.

  51. 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.

  52. 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.

  53. 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.

  54. 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.

  55. 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.

  56. 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.

  57. 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.

  58. 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.

  59. 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.

  60. 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.

  61. 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.

  62. 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.

  63. 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.

  64. 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.

  65. 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.

  66. 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.

  67. 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.

  68. 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.

  69. 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.

  70. 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.

  71. 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.

  72. 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.

  73. Intent to Attend

    Time frame: Treatment session 2 (week 1)

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

  74. Intent to Attend

    Time frame: Treatment session 3 (week 2)

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

  75. Intent to Attend

    Time frame: Treatment session 4 (week 2)

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

  76. Intent to Attend

    Time frame: Treatment session 5 (week 2.5)

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

  77. Intent to Attend

    Time frame: Treatment session 6 (week 3)

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

  78. Intent to Attend

    Time frame: Treatment session 7 (week 4)

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

  79. Intent to Attend

    Time frame: Treatment session 8 (week 4)

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

  80. Intent to Attend

    Time frame: Treatment session 9 (week 5)

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

  81. Intent to Attend

    Time frame: Treatment session 10 (week 5)

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

  82. 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.

Sponsors and collaborators

Lead sponsor

National Center for Telehealth and Technology

Fed

Collaborators

  • The Geneva Foundation

Registry information

Official study title

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)

Acronym: VRPE Extension

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Oct 26, 2011
Registry last updated
Dec 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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