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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
National Center for Telehealth and Technology
Tacoma, Washington, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 26 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.
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Enrollment
162
Time frame: Screening Visit (Day 1)
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Time frame: 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.
Time frame: 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.
Time frame: Screening Visit(Day 1)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: Screening Visit(Day 1)
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 26 Week Follow-up
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Time frame: 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.
Time frame: 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.
Time frame: 12 Week Follow-up
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 26 Week Follow-up
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 2.5 weeks (or after treatment session 5)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 5 weeks (or after treatment session 10)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 12 Week Follow-up
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 26 Week Follow-up
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 2.5 weeks (or after treatment session 5)
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 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.
Time frame: 12 Week Follow-up
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Treatment session 10 (Week 5)