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

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

October 24, 2011
May 22, 2014
October 2011
May 2014   (final data collection date for primary outcome measure)
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
  • Clinician-Administered PTSD Scale (CAPS) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.
Same as current
Complete list of historical versions of study NCT01459705 on ClinicalTrials.gov Archive Site
  • PTSD Checklist- Civilian (PCL-C) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
  • Perceived Stigma Measure (PSS) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.
  • Suicide Risk Assessment [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.
  • Beck Anxiety Inventory (BAI) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
  • Behavior and Sympton Identification Scale (BASIS-24) [ Time Frame: Screening Visit(Day 1) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • Intent to Attend [ Time Frame: Screening Visit (Day 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Side Effects Questionnaire [ Time Frame: Treatment session 1(week 1) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • BASIS-24 [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • Intent to attend [ Time Frame: Treatment session 1 (week 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • PTSD Checklist (PCL-C) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
  • PTSD Checklist (PCL-C) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.
  • PTSD Checklist (PCL-C) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
  • PTSD Checklist (PCL-C) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.
  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.
  • Primary Care PTSD Screen (PC-PTSD) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    The PC-PTSD is a four-item measure designed to screen for PTSD.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.
  • Beck Depression Inventory-II (BDI-II) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: Yes ]
    This self report measure of depression contains 21 items that are rated on a 4 point scale.
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
  • Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
  • Perceived Stigma Measure (PSS) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.
  • Perceived Stigma Measure (PSS) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.
  • Perceived Stigma Measure (PSS) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.
  • Perceived Stigma Measure (PSS) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    Stigma will be measured using a 5 question assessment scale.
  • Suicide Risk Assessment [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.
  • Suicide Risk Assessment [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.
  • Suicide Risk Assessment [ Time Frame: 12 Week follow up ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.
  • Suicide Risk Assessment [ Time Frame: 26 Week follow up ] [ Designated as safety issue: No ]
    Due to the nature of the questions, this is deemed to be of safety nature.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 12 week follow up ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
  • Beck Anxiety Inventory (BAI) [ Time Frame: 26 week follow up ] [ Designated as safety issue: No ]
    The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
  • BASIS-24 [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: 5 weeks (or after treatment session 10) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: 12 week follow up ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • BASIS-24 [ Time Frame: 26 week follow up ] [ Designated as safety issue: Yes ]
    To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Subjective Units of Distress (SUDs) [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: No ]
    Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
  • Side Effects Questionnaire [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Side Effects Questionnaire [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: Yes ]
    The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
  • Intent to attend [ Time Frame: Treatment session 2 (week 1) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 3 (week 2) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 4 (week 2) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 5 (week 2.5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 6 (week 3) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 7 (week 4) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 8 (week 4) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 9 (week 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: Treatment session 10 (week 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
  • Intent to attend [ Time Frame: 2.5 weeks (or after treatment session 5) ] [ Designated as safety issue: No ]
    This is a measure to assess the intent to complete study procedures.
Same as current
Not Provided
Not Provided
 
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Stress Disorders
  • Post-Traumatic Stress Disorder
  • Behavioral: Prolonged Exposure Therapy (PE)
    Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
    Other Name: PE
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Prolonged Exposure Therapy (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.
    Intervention: Behavioral: Virtual Reality Exposure Therapy (VRET)
  • Placebo Comparator: Waitlist
    The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
    Intervention: Behavioral: Waitlist

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
296
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01459705
112226, W81XWH-11-2-0007
Yes
National Center for Telehealth and Technology
National Center for Telehealth and Technology
The Geneva Foundation
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
National Center for Telehealth and Technology
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP