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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-08-2-0015 | Other Grant/Funding Number | UA Army MRMC |
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| Name | Class |
|---|---|
| University of Southern California | OTHER |
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This study is evaluating the efficacy of virtual realty exposure therapy (VRET)by comparing it to prolonged exposure therapy (PE) and a waitlist (WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypotheses that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.
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 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. | 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. | 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. | 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. | 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. | 26 Week follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist (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. |
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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 |
|---|---|---|---|---|---|---|
| National Center for Telehealth and Technology | Tacoma | Washington | 98431 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10533438 | Background | 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 | Background | 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. |
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| ID | Term |
|---|---|
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| 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 |
|
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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. | 2.5 weeks (or after treatment session 5) |
| 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 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 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. | 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. | 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. | 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) |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 31880749 | Derived | Bourassa KJ, Stevens ES, Katz AC, Rothbaum BO, Reger GM, Norr AM. The Impact of Exposure Therapy on Resting Heart Rate and Heart Rate Reactivity Among Active-Duty Soldiers With Posttraumatic Stress Disorder. Psychosom Med. 2020 Jan;82(1):108-114. doi: 10.1097/PSY.0000000000000758. |
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |