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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-11-2-0007 | Other Grant/Funding Number | USMRMC |
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| Name | Class |
|---|---|
| The Geneva Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Active Comparator | 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. |
|
| Virtual Reality Exposure Therapy (VRET) | Experimental | 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. |
|
| Waitlist | Placebo Comparator | The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Behavioral | Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory A Gahm, PhD | DCoE- National Center for Telehealth and Technology | Principal Investigator |
| Greg Reger, PhD | DCoE - National Center for Telehealth and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Womack Clinical Psychology Service | Fort Bragg | North Carolina | 28307 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16891607 | Background | Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052. | |
| 11561934 | Background | Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22. doi: 10.4088/jcp.v62n0808. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments. |
| FG001 | 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. 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. |
| FG002 | Waitlist | The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All participants randomized to a treatment arm included in baseline data analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Baseline scores on the CAPS-W (last week reference) | Posted | Mean | Standard Deviation | units on scale | Screening Visit (Day 1) |
|
6 months. From time of baseline visit to final follow up visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - psychiatric | Psychiatric disorders | Non-systematic Assessment | All three SAE's were for psychiatric hospitalization - not related to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increase in flashbacks | Psychiatric disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Gahm, PhD | DCoE | 253-320-5772 | gregory.a.gahm.civ@mail.mil |
Not provided
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D063367 | Virtual Reality Exposure Therapy |
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D003887 | Desensitization, Psychologic |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| Virtual Reality Exposure Therapy (VRET) | Behavioral | Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments. |
|
|
| Waitlist | Behavioral | This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation |
|
|
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 |
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) |
| 14622073 | Background | Koenen KC, Stellman JM, Stellman SD, Sommer JF Jr. Risk factors for course of posttraumatic stress disorder among Vietnam veterans: a 14-year follow-up of American Legionnaires. J Consult Clin Psychol. 2003 Dec;71(6):980-6. doi: 10.1037/0022-006X.71.6.980. |
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| 9080539 | Background | Shalev AY, Peri T, Orr SP, Bonne O, Pitman RK. Auditory startle responses in help-seeking trauma survivors. Psychiatry Res. 1997 Mar 3;69(1):1-7. doi: 10.1016/s0165-1781(96)03001-6. |
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| 7897056 | Background | Orr SP, Lasko NB, Shalev AY, Pitman RK. Physiologic responses to loud tones in Vietnam veterans with posttraumatic stress disorder. J Abnorm Psychol. 1995 Feb;104(1):75-82. doi: 10.1037//0021-843x.104.1.75. |
| 8932965 | Background | Pitman RK, Orr SP, Altman B, Longpre RE, Poire RE, Macklin ML, Michaels MJ, Steketee GS. Emotional processing and outcome of imaginal flooding therapy in Vietnam veterans with chronic posttraumatic stress disorder. Compr Psychiatry. 1996 Nov-Dec;37(6):409-18. doi: 10.1016/s0010-440x(96)90024-3. |
| 7056906 | Background | Keane TM, Kaloupek DG. Imaginal flooding in the treatment of a posttraumatic stress disorder. J Consult Clin Psychol. 1982 Feb;50(1):138-40. doi: 10.1037//0022-006x.50.1.138. No abstract available. |
| 8434665 | Background | Cardena E, Spiegel D. Dissociative reactions to the San Francisco Bay Area earthquake of 1989. Am J Psychiatry. 1993 Mar;150(3):474-8. doi: 10.1176/ajp.150.3.474. |
| 8184999 | Background | Koopman C, Classen C, Spiegel D. Predictors of posttraumatic stress symptoms among survivors of the Oakland/Berkeley, Calif., firestorm. Am J Psychiatry. 1994 Jun;151(6):888-94. doi: 10.1176/ajp.151.6.888. |
| 14566588 | Background | Reger GM, McGee JS, van der Zaag C, Thiebaux M, Galen Buckwalter JG, Rizzo AA. A 3D virtual environment rod and frame test: the reliability and validity of four traditional scoring methods for older adults. J Clin Exp Neuropsychol. 2003 Dec;25(8):1169-77. doi: 10.1076/jcen.25.8.1169.16733. |
| 8687369 | Background | Rothbaum BO, Hodges L, Watson BA, Kessler CD, Opdyke D. Virtual reality exposure therapy in the treatment of fear of flying: a case report. Behav Res Ther. 1996 May-Jun;34(5-6):477-81. doi: 10.1016/0005-7967(96)00007-1. |
| 11142535 | Background | Rothbaum BO, Hodges L, Smith S, Lee JH, Price L. A controlled study of virtual reality exposure therapy for the fear of flying. J Consult Clin Psychol. 2000 Dec;68(6):1020-6. doi: 10.1037//0022-006x.68.6.1020. |
| 11952201 | Background | Rothbaum BO, Hodges L, Anderson PL, Price L, Smith S. Twelve-month follow-up of virtual reality and standard exposure therapies for the fear of flying. J Consult Clin Psychol. 2002 Apr;70(2):428-32. doi: 10.1037//0022-006x.70.2.428. |
| 7694917 | Background | Rothbaum BO, Hodges LF, Kooper R, Opdyke D, Williford JS, North M. Effectiveness of computer-generated (virtual reality) graded exposure in the treatment of acrophobia. Am J Psychiatry. 1995 Apr;152(4):626-8. doi: 10.1176/ajp.152.4.626. |
| 12038644 | Background | Emmelkamp PM, Krijn M, Hulsbosch AM, de Vries S, Schuemie MJ, van der Mast CA. Virtual reality treatment versus exposure in vivo: a comparative evaluation in acrophobia. Behav Res Ther. 2002 May;40(5):509-16. doi: 10.1016/s0005-7967(01)00023-7. |
| 9613029 | Background | Botella C, Banos RM, Perpina C, Villa H, Alcaniz M, Rey A. Virtual reality treatment of claustrophobia: a case report. Behav Res Ther. 1998 Feb;36(2):239-46. doi: 10.1016/s0005-7967(97)10006-7. |
| 9046678 | Background | Carlin AS, Hoffman HG, Weghorst S. Virtual reality and tactile augmentation in the treatment of spider phobia: a case report. Behav Res Ther. 1997 Feb;35(2):153-8. doi: 10.1016/s0005-7967(96)00085-x. |
| 12296495 | Background | Garcia-Palacios A, Hoffman H, Carlin A, Furness TA 3rd, Botella C. Virtual reality in the treatment of spider phobia: a controlled study. Behav Res Ther. 2002 Sep;40(9):983-93. doi: 10.1016/s0005-7967(01)00068-7. |
| 16942963 | Background | Rothbaum BO, Anderson P, Zimand E, Hodges L, Lang D, Wilson J. Virtual reality exposure therapy and standard (in vivo) exposure therapy in the treatment of fear of flying. Behav Ther. 2006 Mar;37(1):80-90. doi: 10.1016/j.beth.2005.04.004. Epub 2006 Feb 24. |
| 10350931 | Background | Botella C, Perpina C, Banos RM, Garcia-Palacios A. Virtual reality: a new clinical setting lab. Stud Health Technol Inform. 1998;58:73-81. |
| 14756933 | Background | Gershon J, Zimand E, Lemos R, Rothbaum BO, Hodges L. Use of virtual reality as a distractor for painful procedures in a patient with pediatric cancer: a case study. Cyberpsychol Behav. 2003 Dec;6(6):657-61. doi: 10.1089/109493103322725450. |
| 10378165 | Background | Rothbaum BO, Hodges L, Alarcon R, Ready D, Shahar F, Graap K, Pair J, Hebert P, Gotz D, Wills B, Baltzell D. Virtual reality exposure therapy for PTSD Vietnam Veterans: a case study. J Trauma Stress. 1999 Apr;12(2):263-71. doi: 10.1023/A:1024772308758. |
| 15677582 | Background | Bradley R, Greene J, Russ E, Dutra L, Westen D. A multidimensional meta-analysis of psychotherapy for PTSD. Am J Psychiatry. 2005 Feb;162(2):214-27. doi: 10.1176/appi.ajp.162.2.214. |
| 7712061 | Background | Blake DD, Weathers FW, Nagy LM, Kaloupek DG, Gusman FD, Charney DS, Keane TM. The development of a Clinician-Administered PTSD Scale. J Trauma Stress. 1995 Jan;8(1):75-90. doi: 10.1007/BF02105408. |
| 15361745 | Background | Aziz MA, Kenford S. Comparability of telephone and face-to-face interviews in assessing patients with posttraumatic stress disorder. J Psychiatr Pract. 2004 Sep;10(5):307-13. doi: 10.1097/00131746-200409000-00004. |
| 8870294 | Background | Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2. |
| 16530379 | Background | Bolton EE, Gray MJ, Litz BT. A cross-lagged analysis of the relationship between symptoms of PTSD and retrospective reports of exposure. J Anxiety Disord. 2006;20(7):877-95. doi: 10.1016/j.janxdis.2006.01.009. Epub 2006 Mar 10. |
| 8991972 | Background | Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13. |
| 3204199 | Background | Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available. |
| 17050086 | Background | Mackenzie CS, Gekoski WL, Knox VJ. Age, gender, and the underutilization of mental health services: the influence of help-seeking attitudes. Aging Ment Health. 2006 Nov;10(6):574-82. doi: 10.1080/13607860600641200. |
| 15060401 | Background | Pyne JM, Kuc EJ, Schroeder PJ, Fortney JC, Edlund M, Sullivan G. Relationship between perceived stigma and depression severity. J Nerv Ment Dis. 2004 Apr;192(4):278-83. doi: 10.1097/01.nmd.0000120886.39886.a3. |
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| Background | Bryant RA. Cognitive behavior therapy of violence-related posttraumatic stress disorder. Aggression and Violent Behavior. 2000;5:79-97. |
| Background | Foa EB,Steketee GS, Rothbaum BO. Behavioral/cognitive conceptualizations of post-traumatic stress disorder. Behavior Therapy. 1989;20:155-176. |
| Background | Foa EB, Hearst-Ikeda D. Emotional Dissociation in Response to Trauma: An Information-Processing Approach. In: Michelson LK, Ray WJ, eds. Handbook of Dissociation: Theoretical and Clinical Perspectives. New York: Plenum Press; 1996:207-222. |
| Background | Lating JM, Everly GS, Jr. Psychophysiological assessment of PTSD. In: Everly, GS, Jr., Lating LM, eds. Psychotraumatology: Key papers and core concepts in post-traumatic stress. New York: Plenum Press; 1995:129-145. |
| Background | Boudewyns P, Hyer L. Physiological response to combat memories and preliminary treatment outcome in Vietnam veteran PTSD patients treated with direct therapeutic exposure. Behavior Therapy. 1990;21 (1):63-87. |
| Background | Britt TW. The stigma of psychological problems in a work environment: Evidence from the screening of Service Members returning from Bosnia. J of Applied Psych. 2000;30(8):1599-1618 |
| Background | Foa EB, Riggs DS, Massie ED, Yarczower M. The impact of fear activation and anger on the efficacy of exposure treatment for PTSD. Behavior Therapy. 1995;26:487-499. |
| Background | Rizzo AA, Buckwalter JG, van der Zaag C. Virtual Environment Applications for Neuropsychological Assessment and Rehabilitation. In: Stanney K, ed. Handbook of Virtual Environments. New York: L.A. Earlbaum; 2002:1027-1064. |
| Background | Smith SG, Rothbaum BO, Hodges L. Treatment of fear of flying using virtual reality exposure therapy: A single case study. The Behavior Therapist. 1999;22(8):154-158,160. |
| Background | Anderson P, Rothbaum BO, Hodges LF. Virtual reality exposure in the treatment of social anxiety: Two case reports. Cognitive and Behavioral Practice. 2003;10:240-247. |
| Background | Glantz K, Rizzo AA, Graap K. Virtual reality for psychotherapy: Current reality and future possibilities. Psychotherapy: Theory, Research, Practice, Training. 2003;40(1/2):55-67. |
| Background | Rizzo AA, Schultheis MT, Kerns K, Mateer C. Analysis of assets for virtual applications in neuropsychology. Neuropsychological Rehabilitation. 2004;14(1/2):207-239. |
| Background | Rizzo AA, Rothbaum BO, Graap K. Virtual Reality Applications for Combat-Related Posttraumatic Stress Disorder. In: Figley CR, Nash WP, eds. For Those Who Bore the Battle: Combat Stress Injury Theory, Research, and Management. New York: Taylor and Francis Books; 2006. |
| Background | Rothbaum BO, Ruef AM, Litz BT, Han H, Hodges L. Virtual reality exposure therapy of combat-related PTSD: A case study using psychophysiological indicators of outcome. Journal of Cognitive Psychotherapy. 2003;17(2):163-177. |
| Background | Cohen J. Statistical Power Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum Associates; 1988. |
| Background | Cohen J, Cohen P. Applied Multiple Regression/Correlation Analysis for the Behavioral Sciences. Hillsdale: Lawrence Earlbaum; 1983. |
| Background | Foa EB, Hembree E, Rothbaum BO. Prolonged Exposure Therapy for PTSD: Emotional Processing of Traumatic Experiences. New York: Oxford University Press; 2007. |
| Background | Nishith P, Resick PA. Adherence and competence rating scales for prolonged exposure treatment: Unpublished Rating Scale, University of Missouri-St. Louis; 1994. |
| Background | Ajzen I. From intentions to actions: A theory of planned behavior. In: Kuhl J, Beckman, J, eds. Action-Control: From Cognition to Behavior. Heidelberg: Springer; 1985:11-39. |
| Background | Komiya N, Good GE, Sherrod NB. Emotional openness as a predictor of college students' attitudes toward seeking psychological help. J Counsel Psychol. 2000;47(1):138-143. |
| Background | Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG. Simulator Sickness Questionnaire: An enhanced method for quantifying simulator sickness. International Journal of Aviation Psychology. 1993;3(3):203-220. |
| 10533438 | Result | Rothbaum BO, Hodges LF. The use of virtual reality exposure in the treatment of anxiety disorders. Behav Modif. 1999 Oct;23(4):507-25. doi: 10.1177/0145445599234001. |
| 17723027 | Result | Pole N. The psychophysiology of posttraumatic stress disorder: a meta-analysis. Psychol Bull. 2007 Sep;133(5):725-46. doi: 10.1037/0033-2909.133.5.725. |
| 9489273 | Result | Jaycox LH, Foa EB, Morral AR. Influence of emotional engagement and habituation on exposure therapy for PTSD. J Consult Clin Psychol. 1998 Feb;66(1):185-92. doi: 10.1037//0022-006x.66.1.185. |
| 18052556 | Result | Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47. |
| 15229303 | Result | Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603. |
| 7492257 | Result | Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012. |
| 12428777 | Result | Simms LJ, Watson D, Doebbeling BN. Confirmatory factor analyses of posttraumatic stress symptoms in deployed and nondeployed veterans of the Gulf War. J Abnorm Psychol. 2002 Nov;111(4):637-47. doi: 10.1037//0021-843x.111.4.637. |
| 16507803 | Result | Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023. |
| 17353495 | Result | Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82. doi: 10.1001/archinte.167.5.476. |
| BG001 | 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. 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. |
| BG002 | Waitlist | The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. 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. |
| OG002 | Waitlist | The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation |
|
|
| Primary | 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. | Participants who provided data at mid treatment | Posted | Mean | Standard Deviation | units on a scale | 2.5 weeks (or after treatment session 5) |
|
|
|
| Primary | 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. | Participants who provided outcome data at post treatment | Posted | Mean | Standard Deviation | units on a scale | 5 weeks (or after treatment session 10) |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 week follow up |
|
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 26 Week follow up |
|
|
|
|
| Secondary | 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. | Not Posted | Screening Visit (Day 1) |
| Secondary | Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Not Posted | Screening Visit (Day 1) |
| Secondary | Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Not Posted | Screening Visit(Day 1) |
| Secondary | 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. | Not Posted | Screening Visit(Day 1) |
| Secondary | Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Not Posted | Screening Visit(Day 1) |
| Secondary | Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Not Posted | Screening Visit(Day 1) |
| Secondary | Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Not Posted | Screening Visit(Day 1) |
| Secondary | 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. | Not Posted | Screening Visit(Day 1) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Screening Visit (Day 1) |
| Secondary | 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. | Not Posted | Treatment session 1 (week 1) |
| Secondary | 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. | Not Posted | Treatment session 1(week 1) |
| Secondary | 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. | Not Posted | Treatment session 1 (week 1) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 1 (week 1) |
| Secondary | PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | Not Posted | 12 week follow up |
| Secondary | PTSD Checklist (PCL-C) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. | Not Posted | 26 week follow up |
| Secondary | Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Not Posted | 12 Week follow up |
| Secondary | Primary Care PTSD Screen (PC-PTSD) | The PC-PTSD is a four-item measure designed to screen for PTSD. | Not Posted | 26 Week follow up |
| Secondary | Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Not Posted | 12 Week follow up |
| Secondary | Beck Depression Inventory-II (BDI-II) | This self report measure of depression contains 21 items that are rated on a 4 point scale. | Not Posted | 26 Week follow up |
| Secondary | 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. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | 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. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | 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. | Not Posted | 12 Week follow up |
| Secondary | 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. | Not Posted | 26 Week follow up |
| Secondary | Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Not Posted | 12 week follow up |
| Secondary | Perceived Stigma Measure (PSS) | Stigma will be measured using a 5 question assessment scale. | Not Posted | 26 week follow up |
| Secondary | Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Not Posted | 12 Week follow up |
| Secondary | Suicide Risk Assessment | Due to the nature of the questions, this is deemed to be of safety nature. | Not Posted | 26 Week follow up |
| Secondary | Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Not Posted | 12 week follow up |
| Secondary | Beck Anxiety Inventory (BAI) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. | Not Posted | 26 week follow up |
| Secondary | 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. | Not Posted | Treatment session 2 (week 1) |
| Secondary | 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. | Not Posted | Treatment session 3 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 4 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 5 (week 2.5) |
| Secondary | 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. | Not Posted | Treatment session 6 (week 3) |
| Secondary | 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. | Not Posted | Treatment session 7 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 8 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 9 (week 5) |
| Secondary | 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. | Not Posted | Treatment session 10 (week 5) |
| Secondary | 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. | Not Posted | 5 weeks (or after treatment session 10) |
| Secondary | 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. | Not Posted | 2.5 weeks (or after treatment session 5) |
| Secondary | 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. | Not Posted | 12 week follow up |
| Secondary | 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. | Not Posted | 26 week follow up |
| Secondary | 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. | Not Posted | Treatment session 2 (week 1) |
| Secondary | 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. | Not Posted | Treatment session 3 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 4 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 5 (week 2.5) |
| Secondary | 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. | Not Posted | Treatment session 6 (week 3) |
| Secondary | 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. | Not Posted | Treatment session 7 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 8 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 9 (week 5) |
| Secondary | 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. | Not Posted | Treatment session 10 (week 5) |
| Secondary | 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. | Not Posted | Treatment session 2 (week 1) |
| Secondary | 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. | Not Posted | Treatment session 3 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 4 (week 2) |
| Secondary | 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. | Not Posted | Treatment session 5 (week 2.5) |
| Secondary | 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. | Not Posted | Treatment session 6 (week 3) |
| Secondary | 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. | Not Posted | Treatment session 7 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 8 (week 4) |
| Secondary | 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. | Not Posted | Treatment session 9 (week 5) |
| Secondary | 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. | Not Posted | Treatment session 10 (week 5) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 2 (week 1) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 3 (week 2) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 4 (week 2) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 5 (week 2.5) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 6 (week 3) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 7 (week 4) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 8 (week 4) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 9 (week 5) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | Treatment session 10 (week 5) |
| Secondary | Intent to Attend | This is a measure to assess the intent to complete study procedures. | Not Posted | 2.5 weeks (or after treatment session 5) |
| 0 |
| 54 |
| 12 |
| 54 |
| EG001 | 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. 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. | 3 | 54 | 15 | 54 |
| EG002 | Waitlist | The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation | 0 | 54 | 0 | 54 |
|
| Headache | General disorders | Non-systematic Assessment | Headaches |
|
| Dislocated Shoulder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Shoulder dislocation during racket ball which was in in vivo homework exercise |
|
| exacerbation of neck and back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| dizziness | General disorders | Non-systematic Assessment |
|
| homicidal ideation | Psychiatric disorders | Non-systematic Assessment |
|
| intermittent stomach ache and diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| increased intrusive memories | Psychiatric disorders | Non-systematic Assessment |
|
| increased irritability | Psychiatric disorders | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| increased anxiety around weapons | Psychiatric disorders | Non-systematic Assessment |
|
| flu like symptoms | General disorders | Non-systematic Assessment |
|
| cold symptoms | General disorders | Non-systematic Assessment |
|
| syncopal episode | General disorders | Non-systematic Assessment |
|
| rash from ECG lead | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| alcohol consumption | General disorders | Non-systematic Assessment | Alcohol consumption after session |
|
| self percieved persecution | Psychiatric disorders | Non-systematic Assessment | starving self, vague suicidal ideation and homicidal ideation |
|
Not provided
Not provided
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| Slope |
| -13.30 |
| Standard Error of the Mean |
| 4.77 |
| 2-Sided |
| No |
| Superiority or Other |
| Slope | 9.04 | Standard Error of the Mean | 5.11 | 2-Sided | No | Superiority or Other |