Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

Post-Traumatic Stress Disorder Clinical Trial

— VRPE Extension  

Official title:

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01459705
• Other study ID #: 112226
• Secondary ID: W81XWH-11-2-0007
• Status: Completed
• Phase: N/A
• First received: October 24, 2011
• Last updated: November 9, 2015
• Start date: October 2011
• Est. completion date: May 2014

Study information

• Verified date: November 2015
• Source: National Center for Telehealth and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.
• Waitlist
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation

Locations

Country	Name	City	State
United States	Womack Clinical Psychology Service	Fort Bragg	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Telehealth and Technology	The Geneva Foundation

Country where clinical trial is conducted

United States, 

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* Note: There are 77 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Screening Visit (Day 1)	No
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.	2.5 weeks (or after treatment session 5)	No
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.	5 weeks (or after treatment session 10)	No
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.	12 week follow up	No
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.	26 Week follow up	No
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.	Screening Visit (Day 1)	No
Secondary	Primary Care PTSD Screen (PC-PTSD)	The PC-PTSD is a four-item measure designed to screen for PTSD.	Screening Visit (Day 1)	No
Secondary	Beck Depression Inventory-II (BDI-II)	This self report measure of depression contains 21 items that are rated on a 4 point scale.	Screening Visit(Day 1)	Yes
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.	Screening Visit(Day 1)	No
Secondary	Perceived Stigma Measure (PSS)	Stigma will be measured using a 5 question assessment scale.	Screening Visit(Day 1)	No
Secondary	Suicide Risk Assessment	Due to the nature of the questions, this is deemed to be of safety nature.	Screening Visit(Day 1)	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.	Screening Visit(Day 1)	No
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.	Screening Visit(Day 1)	Yes
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Screening Visit (Day 1)	No
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.	Treatment session 1 (week 1)	No
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.	Treatment session 1(week 1)	Yes
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.	Treatment session 1 (week 1)	Yes
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 1 (week 1)	No
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.	2.5 weeks (or after treatment session 5)	No
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.	5 weeks (or after treatment session 10)	No
Secondary	Primary Care PTSD Screen (PC-PTSD)	The PC-PTSD is a four-item measure designed to screen for PTSD.	2.5 weeks (or after treatment session 5)	No
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.	12 week follow up	No
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.	26 week follow up	No
Secondary	Primary Care PTSD Screen (PC-PTSD)	The PC-PTSD is a four-item measure designed to screen for PTSD.	5 weeks (or after treatment session 10)	No
Secondary	Primary Care PTSD Screen (PC-PTSD)	The PC-PTSD is a four-item measure designed to screen for PTSD.	12 Week follow up	No
Secondary	Primary Care PTSD Screen (PC-PTSD)	The PC-PTSD is a four-item measure designed to screen for PTSD.	26 Week follow up	No
Secondary	Beck Depression Inventory-II (BDI-II)	This self report measure of depression contains 21 items that are rated on a 4 point scale.	2.5 weeks (or after treatment session 5)	Yes
Secondary	Beck Depression Inventory-II (BDI-II)	This self report measure of depression contains 21 items that are rated on a 4 point scale.	5 weeks (or after treatment session 10)	Yes
Secondary	Beck Depression Inventory-II (BDI-II)	This self report measure of depression contains 21 items that are rated on a 4 point scale.	12 Week follow up	Yes
Secondary	Beck Depression Inventory-II (BDI-II)	This self report measure of depression contains 21 items that are rated on a 4 point scale.	26 Week follow up	Yes
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.	2.5 weeks (or after treatment session 5)	No
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.	5 weeks (or after treatment session 10)	No
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.	12 Week follow up	No
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.	26 Week follow up	No
Secondary	Perceived Stigma Measure (PSS)	Stigma will be measured using a 5 question assessment scale.	2.5 weeks (or after treatment session 5)	No
Secondary	Perceived Stigma Measure (PSS)	Stigma will be measured using a 5 question assessment scale.	5 weeks (or after treatment session 10)	No
Secondary	Perceived Stigma Measure (PSS)	Stigma will be measured using a 5 question assessment scale.	12 week follow up	No
Secondary	Perceived Stigma Measure (PSS)	Stigma will be measured using a 5 question assessment scale.	26 week follow up	No
Secondary	Suicide Risk Assessment	Due to the nature of the questions, this is deemed to be of safety nature.	2.5 weeks (or after treatment session 5)	No
Secondary	Suicide Risk Assessment	Due to the nature of the questions, this is deemed to be of safety nature.	5 weeks (or after treatment session 10)	No
Secondary	Suicide Risk Assessment	Due to the nature of the questions, this is deemed to be of safety nature.	12 Week follow up	No
Secondary	Suicide Risk Assessment	Due to the nature of the questions, this is deemed to be of safety nature.	26 Week follow up	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.	2.5 weeks (or after treatment session 5)	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.	5 weeks (or after treatment session 10)	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.	12 week follow up	No
Secondary	Beck Anxiety Inventory (BAI)	The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.	26 week follow up	No
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.	Treatment session 2 (week 1)	Yes
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.	Treatment session 3 (week 2)	Yes
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.	Treatment session 4 (week 2)	Yes
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.	Treatment session 5 (week 2.5)	Yes
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.	Treatment session 6 (week 3)	Yes
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.	Treatment session 7 (week 4)	Yes
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.	Treatment session 8 (week 4)	Yes
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.	Treatment session 9 (week 5)	Yes
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.	Treatment session 10 (week 5)	Yes
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.	5 weeks (or after treatment session 10)	Yes
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.	2.5 weeks (or after treatment session 5)	Yes
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.	12 week follow up	Yes
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.	26 week follow up	Yes
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.	Treatment session 2 (week 1)	No
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.	Treatment session 3 (week 2)	No
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.	Treatment session 4 (week 2)	No
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.	Treatment session 5 (week 2.5)	No
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.	Treatment session 6 (week 3)	No
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.	Treatment session 7 (week 4)	No
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.	Treatment session 8 (week 4)	No
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.	Treatment session 9 (week 5)	No
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.	Treatment session 10 (week 5)	No
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.	Treatment session 2 (week 1)	Yes
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.	Treatment session 3 (week 2)	Yes
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.	Treatment session 4 (week 2)	Yes
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.	Treatment session 5 (week 2.5)	Yes
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.	Treatment session 6 (week 3)	Yes
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.	Treatment session 7 (week 4)	Yes
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.	Treatment session 8 (week 4)	Yes
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.	Treatment session 9 (week 5)	Yes
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.	Treatment session 10 (week 5)	Yes
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 2 (week 1)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 3 (week 2)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 4 (week 2)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 5 (week 2.5)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 6 (week 3)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 7 (week 4)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 8 (week 4)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 9 (week 5)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	Treatment session 10 (week 5)	No
Secondary	Intent to Attend	This is a measure to assess the intent to complete study procedures.	2.5 weeks (or after treatment session 5)	No