Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

Study Overview
=================
Brief Summary
-----------------
This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.

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.

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

Conditions
-----------------
Stress Disorders, Post-Traumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure Therapy (PE)
* Behavioral: Virtual Reality Exposure Therapy (VRET)
* Behavioral: Waitlist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PTSD diagnosis as assessed by CAPS history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF) non sexually based deployment related trauma three or more months since index trauma stable on psychotropic medication for 30 days Exclusion Criteria: index trauma in the last three months history of schizophrenia, other psychotic or bipolar disorder history of organic brain disorder suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months ongoing threatening situation current drug or alcohol dependence history of seizures prior history of PE for PTSD other current psychotherapy physical condition that interferes with proper use of Virtual Reality head mounted display history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolonged Exposure Therapy (PE)<br>The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events. | Behavioral: Prolonged Exposure Therapy (PE)<br>* Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.<br>* Other names: PE;|
| Experimental: Virtual Reality Exposure Therapy (VRET)<br>The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure. | Behavioral: Virtual Reality Exposure Therapy (VRET)<br>* Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.<br>* Other names: VRET;|
| Placebo Comparator: Waitlist<br>The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. | Behavioral: Waitlist<br>* This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation<br>* Other names: Waitlist Control Group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician-Administered PTSD Scale (CAPS) | 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. | Screening Visit (Day 1) | 
| 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.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. | 2.5 weeks (or after treatment session 5) | 
| 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.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 weeks (or after treatment session 10) | 
| 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.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. | 12 week follow up | 
| 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.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. | 26 Week follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Checklist- Civilian (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | Screening Visit (Day 1) | 
| Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Screening Visit (Day 1) | 
| Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Screening Visit(Day 1) | 
| 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. | Screening Visit(Day 1) | 
| Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Screening Visit(Day 1) | 
| Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Screening Visit(Day 1) | 
| Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Screening Visit(Day 1) | 
| Behavior and Sympton Identification Scale (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. | Screening Visit(Day 1) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Screening Visit (Day 1) | 
| 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. | Treatment session 1 (week 1) | 
| 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. | Treatment session 1(week 1) | 
| 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. | Treatment session 1 (week 1) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 1 (week 1) | 
| PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | 2.5 weeks (or after treatment session 5) | 
| PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | 5 weeks (or after treatment session 10) | 
| Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | 2.5 weeks (or after treatment session 5) | 
| PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | 12 week follow up | 
| PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | 26 week follow up | 
| Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | 5 weeks (or after treatment session 10) | 
| Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | 12 Week follow up | 
| Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | 26 Week follow up | 
| Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | 2.5 weeks (or after treatment session 5) | 
| Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | 5 weeks (or after treatment session 10) | 
| Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | 12 Week follow up | 
| Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | 26 Week follow up | 
| 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. | 2.5 weeks (or after treatment session 5) | 
| 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. | 5 weeks (or after treatment session 10) | 
| 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. | 12 Week follow up | 
| 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. | 26 Week follow up | 
| Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | 2.5 weeks (or after treatment session 5) | 
| Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | 5 weeks (or after treatment session 10) | 
| Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | 12 week follow up | 
| Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | 26 week follow up | 
| Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | 2.5 weeks (or after treatment session 5) | 
| Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | 5 weeks (or after treatment session 10) | 
| Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | 12 Week follow up | 
| Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | 26 Week follow up | 
| Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | 2.5 weeks (or after treatment session 5) | 
| Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | 5 weeks (or after treatment session 10) | 
| Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | 12 week follow up | 
| Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | 26 week follow up | 
| 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. | Treatment session 2 (week 1) | 
| 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. | Treatment session 3 (week 2) | 
| 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. | Treatment session 4 (week 2) | 
| 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. | Treatment session 5 (week 2.5) | 
| 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. | Treatment session 6 (week 3) | 
| 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. | Treatment session 7 (week 4) | 
| 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. | Treatment session 8 (week 4) | 
| 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. | Treatment session 9 (week 5) | 
| 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. | Treatment session 10 (week 5) | 
| 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. | 5 weeks (or after treatment session 10) | 
| 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. | 2.5 weeks (or after treatment session 5) | 
| 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. | 12 week follow up | 
| 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. | 26 week follow up | 
| 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. | Treatment session 2 (week 1) | 
| 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. | Treatment session 3 (week 2) | 
| 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. | Treatment session 4 (week 2) | 
| 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. | Treatment session 5 (week 2.5) | 
| 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. | Treatment session 6 (week 3) | 
| 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. | Treatment session 7 (week 4) | 
| 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. | Treatment session 8 (week 4) | 
| 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. | Treatment session 9 (week 5) | 
| 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. | Treatment session 10 (week 5) | 
| 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. | Treatment session 2 (week 1) | 
| 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. | Treatment session 3 (week 2) | 
| 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. | Treatment session 4 (week 2) | 
| 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. | Treatment session 5 (week 2.5) | 
| 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. | Treatment session 6 (week 3) | 
| 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. | Treatment session 7 (week 4) | 
| 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. | Treatment session 8 (week 4) | 
| 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. | Treatment session 9 (week 5) | 
| 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. | Treatment session 10 (week 5) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 2 (week 1) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 3 (week 2) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 4 (week 2) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 5 (week 2.5) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 6 (week 3) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 7 (week 4) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 8 (week 4) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 9 (week 5) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | Treatment session 10 (week 5) | 
| Intent to Attend | This is a measure to assess the intent to complete study procedures. | 2.5 weeks (or after treatment session 5) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Combat Disorders, Exposure Therapy, Army Personnel