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Exposure Therapy for Active Duty Soldiers With Post Traumatic Stress Disorder (VRPE)

Primary Purpose

Stress Disorders, Post Traumatic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy (PE)
Virtual Reality Exposure Therapy (VRET)
Waitlist
Sponsored by
National Center for Telehealth and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post Traumatic focused on measuring Combat Disorders, Exposure Therapy, Army Personnel

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • PTSD diagnosis as assessed by CAPS
  • history of deployment in support of OIF/OEF
  • non sexually based deployment related trauma
  • three or more months since index trauma
  • stable on psychotropic medications 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

Sites / Locations

  • National Center for Telehealth and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Prolonged Exposure Therapy (PE)

Virtual Reality Exposure Therapy (VRET)

Waitlist

Arm 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.

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.

The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.

Outcomes

Primary Outcome Measures

Clinician-Administered PTSD Scale (CAPS)
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)
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)
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)
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)
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.

Secondary Outcome Measures

PTSD Checklist (PCL-C)
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)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Beck Depression Inventory-II (BDI-II)
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)
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)
Stigma will be measured using a 5 question assessment scale.
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
BASIS-24
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)
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
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.
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
PTSD Checklist (PCL-C)
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)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Beck Depression Inventory-II (BDI-II)
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)
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)
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)
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)
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)
Stigma will be measured using a 5 question assessment scale.
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
BASIS-24
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
August 30, 2010
Last Updated
April 13, 2015
Sponsor
National Center for Telehealth and Technology
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT01193725
Brief Title
Exposure Therapy for Active Duty Soldiers With Post Traumatic Stress Disorder
Acronym
VRPE
Official Title
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Telehealth and Technology
Collaborators
University of Southern California

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is evaluating the efficacy of virtual realty 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 hypotheses 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post Traumatic
Keywords
Combat Disorders, Exposure Therapy, Army Personnel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prolonged Exposure Therapy (PE)
Arm Type
Active Comparator
Arm 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.
Arm Title
Virtual Reality Exposure Therapy (VRET)
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
Placebo Comparator
Arm Description
The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy (PE)
Other Intervention Name(s)
PE
Intervention Description
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure Therapy (VRET)
Other Intervention Name(s)
VRE, VRET
Intervention Description
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Other Intervention Name(s)
WL, Waitlist Control Group
Intervention Description
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Primary Outcome Measure Information:
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.
Time Frame
Screening Visit ( Day 1)
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.
Time Frame
2.5 weeks (or after treatment session 5)
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.
Time Frame
5 weeks (or after treatment session 10)
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.
Time Frame
12 Week follow-up
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.
Time Frame
26 Week follow-up
Secondary Outcome Measure Information:
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
Screening Visit (Day 1)
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)
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)
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)
Title
Perceived Stigma Measure (PSS)
Description
Stigma will be measured using a 5 question assessment scale.
Time Frame
Screening Visit(Day 1)
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)
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)
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
Screening Visit(Day 1)
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)
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)
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)
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)
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
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
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)
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)
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
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
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)
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)
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
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
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)
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)
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
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
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)
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)
Title
Perceived Stigma Measure (PSS)
Description
Stigma will be measured using a 5 question assessment scale.
Time Frame
12 Week Follow-up
Title
Perceived Stigma Measure (PSS)
Description
Stigma will be measured using a 5 question assessment scale.
Time Frame
26 Week Follow-up
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)
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)
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
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
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PTSD diagnosis as assessed by CAPS history of deployment in support of OIF/OEF non sexually based deployment related trauma three or more months since index trauma stable on psychotropic medications 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory A Gahm, PhD
Organizational Affiliation
DCoE - National Center for Telehealth and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Greg Reger, PhD
Organizational Affiliation
DCoE - National Center for Telehealth and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for Telehealth and Technology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States

12. IPD Sharing Statement

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