Comparing Virtual Reality Exposure Therapy to Prolonged Exposure (VRPE Extension)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01459705 |
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Recruitment Status :
Completed
First Posted : October 26, 2011
Results First Posted : December 14, 2015
Last Update Posted : December 14, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stress Disorders Post-Traumatic Stress Disorder | Behavioral: Prolonged Exposure Therapy (PE) Behavioral: Virtual Reality Exposure Therapy (VRET) Behavioral: Waitlist | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 162 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD) |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | May 2014 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Behavioral: Prolonged Exposure Therapy (PE)
Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
Other Name: PE |
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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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Behavioral: 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.
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.
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Behavioral: Waitlist
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
Other Names:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Perceived Stigma Measure (PSS) [ Time Frame: Screening Visit(Day 1) ]Stigma will be measured using a 5 question assessment scale.
- Suicide Risk Assessment [ Time Frame: Screening Visit(Day 1) ]Due to the nature of the questions, this is deemed to be of safety nature.
- 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.
- 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.
- Intent to Attend [ Time Frame: Screening Visit (Day 1) ]This is a measure to assess the intent to complete study procedures.
- 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.
- 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.
- 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.
- Intent to Attend [ Time Frame: Treatment session 1 (week 1) ]This is a measure to assess the intent to complete study procedures.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Perceived Stigma Measure (PSS) [ Time Frame: 2.5 weeks (or after treatment session 5) ]Stigma will be measured using a 5 question assessment scale.
- Perceived Stigma Measure (PSS) [ Time Frame: 5 weeks (or after treatment session 10) ]Stigma will be measured using a 5 question assessment scale.
- Perceived Stigma Measure (PSS) [ Time Frame: 12 week follow up ]Stigma will be measured using a 5 question assessment scale.
- Perceived Stigma Measure (PSS) [ Time Frame: 26 week follow up ]Stigma will be measured using a 5 question assessment scale.
- 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.
- 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.
- Suicide Risk Assessment [ Time Frame: 12 Week follow up ]Due to the nature of the questions, this is deemed to be of safety nature.
- Suicide Risk Assessment [ Time Frame: 26 Week follow up ]Due to the nature of the questions, this is deemed to be of safety nature.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Intent to Attend [ Time Frame: Treatment session 2 (week 1) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 3 (week 2) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 4 (week 2) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 5 (week 2.5) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 6 (week 3) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 7 (week 4) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 8 (week 4) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 9 (week 5) ]This is a measure to assess the intent to complete study procedures.
- Intent to Attend [ Time Frame: Treatment session 10 (week 5) ]This is a measure to assess the intent to complete study procedures.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459705
| United States, North Carolina | |
| Womack Clinical Psychology Service | |
| Fort Bragg, North Carolina, United States, 28307 | |
| 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 |
Other Publications:
| Responsible Party: | National Center for Telehealth and Technology |
| ClinicalTrials.gov Identifier: | NCT01459705 |
| Other Study ID Numbers: |
112226 W81XWH-11-2-0007 ( Other Grant/Funding Number: USMRMC ) |
| First Posted: | October 26, 2011 Key Record Dates |
| Results First Posted: | December 14, 2015 |
| Last Update Posted: | December 14, 2015 |
| Last Verified: | November 2015 |
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Combat Disorders Exposure Therapy Army Personnel |
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Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic |
Pathologic Processes Trauma and Stressor Related Disorders Mental Disorders |

