Post-Traumatic Stress Disorder, Stress Disorders
Conditions
Keywords
Combat Disorders, Exposure Therapy, Army Personnel
Brief summary
This study is evaluating the efficacy of virtual reality exposure therapy (VRET) by comparing it to prolonged exposure therapy (PE) and a waitlist(WL) group for the treatment of post traumatic stress disorder (PTSD) in active duty (AD) Soldiers with combat-related trauma. The investigators will test the general hypothesis that 10 sessions of VRET or PE will successfully treat PTSD, therapeutically affect levels of physiological arousal, and significantly reduce perceptions of stigma toward seeking behavioral health services.
Detailed description
The rationale for this study is based on growing evidence demonstrating that VRET is an efficacious treatment for PTSD and holds the potential to improve access to care for Soldiers who would otherwise avoid treatment. Although PE is considered one of the most effective cognitive-behavioral therapies (CBT) for treatments for PTSD, there are reasons why it may not be the most viable option for many Soldiers. First, prolonged exposure requires a level of emotional engagement during exposure to the trauma that many patients are unable to obtain. Second, stigma and concerns about how Soldiers will be perceived by peers and leadership has a dramatic impact on whether a Soldier will seek care. VRET may address these concerns and may also improve treatment outcomes and access to care by augmenting the patient's re-living of the trauma with a sensory-rich environment and moderating stigma perceptions by offering non-traditional treatment that is a preferable option for many Soldiers who are reluctant to seek out traditional talk therapies. Despite its promise as a viable treatment option, few studies have examined VRET for combat-related PTSD and there are no published studies that have compared VRET to PE in the treatment of combat-related PTSD. Positive results may provide new treatment options for all Soldiers, but should prove to be an especially attractive option for Soldiers who either do not respond to, or are reluctant to engage in other established therapies such as PE.
Interventions
BEHAVIORALProlonged Exposure Therapy (PE)
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
BEHAVIORALVirtual Reality Exposure Therapy (VRET)
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
BEHAVIORALWaitlist
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Sponsors
The Geneva Foundation
National Center for Telehealth and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* PTSD diagnosis as assessed by CAPS * history of deployment in support of Operation Iraqi Freedom/ Operation Enduring Freedom(OIF/OEF) * non sexually based deployment related trauma * three or more months since index trauma * stable on psychotropic medication for 30 days
Exclusion criteria
* index trauma in the last three months * history of schizophrenia, other psychotic or bipolar disorder * history of organic brain disorder * suicidal risk or intent or self-mutilating behavior requiring hospitalization in the last 6 months * ongoing threatening situation * current drug or alcohol dependence * history of seizures * prior history of PE for PTSD * other current psychotherapy * physical condition that interferes with proper use of Virtual Reality head mounted display * history of loss of consciousness since entering active duty service greater than 15 minutes history of schizophrenia, other psychotic or bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician-Administered PTSD Scale (CAPS) | Screening Visit (Day 1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary Care PTSD Screen (PC-PTSD) | Screening Visit (Day 1) | The PC-PTSD is a four-item measure designed to screen for PTSD. |
| Beck Depression Inventory-II (BDI-II) | Screening Visit(Day 1) | This self report measure of depression contains 21 items that are rated on a 4 point scale. |
| Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS) | Screening Visit(Day 1) | The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma. |
| Perceived Stigma Measure (PSS) | Screening Visit(Day 1) | Stigma will be measured using a 5 question assessment scale. |
| Suicide Risk Assessment | Screening Visit(Day 1) | Due to the nature of the questions, this is deemed to be of safety nature. |
| Beck Anxiety Inventory (BAI) | Screening Visit(Day 1) | The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression. |
| PTSD Checklist- Civilian (PCL-C) | Screening Visit (Day 1) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. |
| Intent to Attend | Screening Visit (Day 1) | This is a measure to assess the intent to complete study procedures. |
| Subjective Units of Distress (SUDs) | Treatment session 1 (week 1) | Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation. |
| Side Effects Questionnaire | Treatment session 1(week 1) | 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. |
| BASIS-24 | Treatment session 1 (week 1) | 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. |
| PTSD Checklist (PCL-C) | 2.5 weeks (or after treatment session 5) | The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale. |
| Behavior and Sympton Identification Scale (BASIS-24) | Screening Visit(Day 1) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| 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. | 54 |
| 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 | 54 |
| Total | 162 |
Baseline characteristics
| Characteristic | Virtual Reality Exposure Therapy (VRET) | Waitlist | Prolonged Exposure Therapy (PE) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 54 Participants | 54 Participants | 162 Participants |
| Age, Continuous | 29.52 years STANDARD_DEVIATION 6.47 | 30.39 years STANDARD_DEVIATION 6.45 | 30.89 years STANDARD_DEVIATION 7.09 | 30.27 years STANDARD_DEVIATION 6.66 |
| Region of Enrollment United States | 54 participants | 54 participants | 54 participants | 162 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 52 Participants | 53 Participants | 51 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 54 | 15 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 3 / 54 | 0 / 54 |
Outcome results
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.
Time frame: 2.5 weeks (or after treatment session 5)
Population: Participants who provided data at mid treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale (CAPS) | 65.03 units on a scale | Standard Deviation 29.19 |
| Virtual Reality Exposure Therapy (VRET) | Clinician-Administered PTSD Scale (CAPS) | 71.19 units on a scale | Standard Deviation 23.27 |
| Waitlist | Clinician-Administered PTSD Scale (CAPS) | 74.73 units on a scale | Standard Deviation 21.78 |
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.
Time frame: Screening Visit (Day 1)
Population: Baseline scores on the CAPS-W (last week reference)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale (CAPS) | 78.28 units on scale | Standard Deviation 16.35 |
| Virtual Reality Exposure Therapy (VRET) | Clinician-Administered PTSD Scale (CAPS) | 80.44 units on scale | Standard Deviation 16.23 |
| Waitlist | Clinician-Administered PTSD Scale (CAPS) | 78.89 units on scale | Standard Deviation 16.87 |
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.
Time frame: 12 week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale (CAPS) | 36.63 units on a scale | Standard Deviation 31.8 |
| Virtual Reality Exposure Therapy (VRET) | Clinician-Administered PTSD Scale (CAPS) | 55.88 units on a scale | Standard Deviation 31.1 |
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.
Time frame: 5 weeks (or after treatment session 10)
Population: Participants who provided outcome data at post treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale (CAPS) | 44.28 units on a scale | Standard Deviation 33.73 |
| Virtual Reality Exposure Therapy (VRET) | Clinician-Administered PTSD Scale (CAPS) | 57.07 units on a scale | Standard Deviation 32.32 |
| Waitlist | Clinician-Administered PTSD Scale (CAPS) | 68.06 units on a scale | Standard Deviation 24.27 |
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.
Time frame: 26 Week follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prolonged Exposure Therapy (PE) | Clinician-Administered PTSD Scale (CAPS) | 38.33 units on a scale | Standard Deviation 28.49 |
| Virtual Reality Exposure Therapy (VRET) | Clinician-Administered PTSD Scale (CAPS) | 54.47 units on a scale | Standard Deviation 28.62 |
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 26 Week follow up
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.
Time frame: Screening Visit(Day 1)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 1 (week 1)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Screening Visit (Day 1)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 8 (week 4)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 7 (week 4)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 6 (week 3)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 5 (week 2.5)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 4 (week 2)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 9 (week 5)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 10 (week 5)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: 2.5 weeks (or after treatment session 5)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 3 (week 2)
Secondary
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Time frame: Treatment session 2 (week 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2.5 weeks (or after treatment session 5)
Secondary
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 26 week follow up
Secondary
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: Screening Visit(Day 1)
Secondary
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 2.5 weeks (or after treatment session 5)
Secondary
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 5 weeks (or after treatment session 10)
Secondary
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Time frame: 12 week follow up
Secondary
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)
Secondary
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
Secondary
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
Secondary
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)
Secondary
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)
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.
Time frame: Screening Visit (Day 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.
Time frame: 5 weeks (or after treatment session 10)
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.
Time frame: 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.
Time frame: 26 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.
Time frame: 2.5 weeks (or after treatment session 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Treatment session 10 (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.
Time frame: Treatment session 1 (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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Treatment session 10 (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.
Time frame: Treatment session 3 (week 2)
Secondary
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)
Secondary
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 12 Week follow up
Secondary
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)
Secondary
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: 26 Week follow up
Secondary
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Time frame: Screening Visit(Day 1)