- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01459705
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure (VRPE Extension)
November 9, 2015 updated by: National Center for Telehealth and Technology
Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Fort Bragg, North Carolina, United States, 28307
- Womack Clinical Psychology Service
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
Other Names:
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Experimental: 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.
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Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
Other Names:
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Placebo Comparator: Waitlist
The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.
|
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: 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.
|
Screening Visit (Day 1)
|
Clinician-Administered PTSD Scale (CAPS)
Time Frame: 2.5 weeks (or after treatment session 5)
|
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)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 12 week follow up
|
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)
Time Frame: 26 Week follow up
|
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity.
Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.We used total scores as the primary outcome.
Minimum possible score was 0, maximum possible score was 136.
Higher scores indicated higher levels of symptoms.
|
26 Week follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PTSD Checklist- Civilian (PCL-C)
Time Frame: Screening Visit (Day 1)
|
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)
Time Frame: Screening Visit (Day 1)
|
The PC-PTSD is a four-item measure designed to screen for PTSD.
|
Screening Visit (Day 1)
|
Beck Depression Inventory-II (BDI-II)
Time Frame: Screening Visit(Day 1)
|
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)
Time Frame: 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.
|
Screening Visit(Day 1)
|
Perceived Stigma Measure (PSS)
Time Frame: Screening Visit(Day 1)
|
Stigma will be measured using a 5 question assessment scale.
|
Screening Visit(Day 1)
|
Suicide Risk Assessment
Time Frame: Screening Visit(Day 1)
|
Due to the nature of the questions, this is deemed to be of safety nature.
|
Screening Visit(Day 1)
|
Beck Anxiety Inventory (BAI)
Time Frame: Screening Visit(Day 1)
|
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)
Time Frame: 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.
|
Screening Visit(Day 1)
|
Intent to Attend
Time Frame: Screening Visit (Day 1)
|
This is a measure to assess the intent to complete study procedures.
|
Screening Visit (Day 1)
|
Subjective Units of Distress (SUDs)
Time Frame: 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.
|
Treatment session 1 (week 1)
|
Side Effects Questionnaire
Time Frame: 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.
|
Treatment session 1(week 1)
|
BASIS-24
Time Frame: 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.
|
Treatment session 1 (week 1)
|
Intent to Attend
Time Frame: Treatment session 1 (week 1)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 1 (week 1)
|
PTSD Checklist (PCL-C)
Time Frame: 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.
|
2.5 weeks (or after treatment session 5)
|
PTSD Checklist (PCL-C)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 2.5 weeks (or after treatment session 5)
|
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)
Time Frame: 12 week follow up
|
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)
Time Frame: 26 week follow up
|
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)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 12 Week follow up
|
The PC-PTSD is a four-item measure designed to screen for PTSD.
|
12 Week follow up
|
Primary Care PTSD Screen (PC-PTSD)
Time Frame: 26 Week follow up
|
The PC-PTSD is a four-item measure designed to screen for PTSD.
|
26 Week follow up
|
Beck Depression Inventory-II (BDI-II)
Time Frame: 2.5 weeks (or after treatment session 5)
|
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)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 12 Week follow up
|
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)
Time Frame: 26 Week follow up
|
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)
Time Frame: 2.5 weeks (or after treatment session 5)
|
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)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 12 Week follow up
|
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)
Time Frame: 26 Week follow up
|
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)
Time Frame: 2.5 weeks (or after treatment session 5)
|
Stigma will be measured using a 5 question assessment scale.
|
2.5 weeks (or after treatment session 5)
|
Perceived Stigma Measure (PSS)
Time Frame: 5 weeks (or after treatment session 10)
|
Stigma will be measured using a 5 question assessment scale.
|
5 weeks (or after treatment session 10)
|
Perceived Stigma Measure (PSS)
Time Frame: 12 week follow up
|
Stigma will be measured using a 5 question assessment scale.
|
12 week follow up
|
Perceived Stigma Measure (PSS)
Time Frame: 26 week follow up
|
Stigma will be measured using a 5 question assessment scale.
|
26 week follow up
|
Suicide Risk Assessment
Time Frame: 2.5 weeks (or after treatment session 5)
|
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
Time Frame: 5 weeks (or after treatment session 10)
|
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
Time Frame: 12 Week follow up
|
Due to the nature of the questions, this is deemed to be of safety nature.
|
12 Week follow up
|
Suicide Risk Assessment
Time Frame: 26 Week follow up
|
Due to the nature of the questions, this is deemed to be of safety nature.
|
26 Week follow up
|
Beck Anxiety Inventory (BAI)
Time Frame: 2.5 weeks (or after treatment session 5)
|
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)
Time Frame: 5 weeks (or after treatment session 10)
|
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)
Time Frame: 12 week follow up
|
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)
Time Frame: 26 week follow up
|
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
|
26 week follow up
|
BASIS-24
Time Frame: Treatment session 2 (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.
|
Treatment session 2 (week 1)
|
BASIS-24
Time Frame: Treatment session 3 (week 2)
|
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
Time Frame: Treatment session 4 (week 2)
|
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
Time Frame: Treatment session 5 (week 2.5)
|
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
Time Frame: Treatment session 6 (week 3)
|
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
Time Frame: Treatment session 7 (week 4)
|
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
Time Frame: Treatment session 8 (week 4)
|
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
Time Frame: Treatment session 9 (week 5)
|
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
Time Frame: Treatment session 10 (week 5)
|
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
Time Frame: 5 weeks (or after treatment session 10)
|
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
Time Frame: 2.5 weeks (or after treatment session 5)
|
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
Time Frame: 12 week follow up
|
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
Time Frame: 26 week follow up
|
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)
Time Frame: Treatment session 2 (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.
|
Treatment session 2 (week 1)
|
Subjective Units of Distress (SUDs)
Time Frame: Treatment session 3 (week 2)
|
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)
Time Frame: Treatment session 4 (week 2)
|
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)
Time Frame: Treatment session 5 (week 2.5)
|
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)
Time Frame: Treatment session 6 (week 3)
|
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)
Time Frame: Treatment session 7 (week 4)
|
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)
Time Frame: Treatment session 8 (week 4)
|
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)
Time Frame: Treatment session 9 (week 5)
|
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)
Time Frame: Treatment session 10 (week 5)
|
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
Time Frame: Treatment session 2 (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.
|
Treatment session 2 (week 1)
|
Side Effects Questionnaire
Time Frame: Treatment session 3 (week 2)
|
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
Time Frame: Treatment session 4 (week 2)
|
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
Time Frame: Treatment session 5 (week 2.5)
|
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
Time Frame: Treatment session 6 (week 3)
|
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
Time Frame: Treatment session 7 (week 4)
|
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
Time Frame: Treatment session 8 (week 4)
|
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
Time Frame: Treatment session 9 (week 5)
|
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
Time Frame: Treatment session 10 (week 5)
|
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
Time Frame: Treatment session 2 (week 1)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 2 (week 1)
|
Intent to Attend
Time Frame: Treatment session 3 (week 2)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 3 (week 2)
|
Intent to Attend
Time Frame: Treatment session 4 (week 2)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 4 (week 2)
|
Intent to Attend
Time Frame: Treatment session 5 (week 2.5)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 5 (week 2.5)
|
Intent to Attend
Time Frame: Treatment session 6 (week 3)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 6 (week 3)
|
Intent to Attend
Time Frame: Treatment session 7 (week 4)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 7 (week 4)
|
Intent to Attend
Time Frame: Treatment session 8 (week 4)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 8 (week 4)
|
Intent to Attend
Time Frame: Treatment session 9 (week 5)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 9 (week 5)
|
Intent to Attend
Time Frame: Treatment session 10 (week 5)
|
This is a measure to assess the intent to complete study procedures.
|
Treatment session 10 (week 5)
|
Intent to Attend
Time Frame: 2.5 weeks (or after treatment session 5)
|
This is a measure to assess the intent to complete study procedures.
|
2.5 weeks (or after treatment session 5)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Gregory A Gahm, PhD, DCoE- National Center for Telehealth and Technology
- Principal Investigator: Greg Reger, PhD, DCoE - National Center for Telehealth and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
- 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.
- 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.
- Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
- Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
October 24, 2011
First Submitted That Met QC Criteria
October 25, 2011
First Posted (Estimate)
October 26, 2011
Study Record Updates
Last Update Posted (Estimate)
December 14, 2015
Last Update Submitted That Met QC Criteria
November 9, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112226
- W81XWH-11-2-0007 (Other Grant/Funding Number: USMRMC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Traumatic Stress Disorder
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