Stress DisordersVRPE ExtensionNCT01459705

Comparing Virtual Reality Exposure Therapy to Prolonged Exposure

A study testing Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET) and Waitlist in people with Stress Disorders and Post-Traumatic Stress Disorder, run by National Center for Telehealth and Technology at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Stress Disorders, Post-Traumatic Stress Disorder
What is being tested?: Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET) and Waitlist
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 162 participants
Where: 1 siteUnited States
Study dates: Oct 2011to May 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Womack Clinical Psychology Service
Fort Bragg, North Carolina, 28307

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Stress Disorders, Post-Traumatic Stress Disorder
Being tested: Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET), Waitlist
Keywords: Combat Disorders, Exposure Therapy, Army Personnel
Medical subject headings: Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Combat Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prolonged Exposure Therapy (PE)Behavioural
Also called 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)Behavioural
Also called VRE, VRET
Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
WaitlistBehavioural
Also called WL, Waitlist Control Group
This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation

Study groups in NCT01459705
Study group	Role	What they receive
Prolonged Exposure Therapy (PE)	Active comparator	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. Receives: Behavioral: Prolonged Exposure Therapy (PE)
Virtual Reality Exposure Therapy (VRET)	Experimental	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. Receives: Behavioral: Virtual Reality Exposure Therapy (VRET)
Waitlist	Placebo comparator	The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation. Receives: Behavioral: Waitlist

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Screening Visit (Day 1)
Clinician-Administered PTSD Scale (CAPS)
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.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.
Measured: 2.5 weeks (or after treatment session 5)
Clinician-Administered PTSD Scale (CAPS)
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.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.
Measured: 5 weeks (or after treatment session 10)
Clinician-Administered PTSD Scale (CAPS)
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.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.
Measured: 12 week follow up
Clinician-Administered PTSD Scale (CAPS)
The CAPS is a structured interview that assesses all DSM-IV PTSD criteria in terms of frequency and intensity. Scores are computed for Intrusion, Avoidance and Hyperarousal symptom clusters, as well as a Total score.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.
Measured: 26 Week follow up

Secondary outcomes (82)

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.
Measured: Screening Visit (Day 1)
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Measured: Screening Visit (Day 1)
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Measured: Screening Visit(Day 1)
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Measured: Screening Visit(Day 1)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Measured: Screening Visit(Day 1)
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Screening Visit(Day 1)
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Measured: Screening Visit(Day 1)
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.
Measured: Screening Visit(Day 1)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Screening Visit (Day 1)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 1 (week 1)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 1(week 1)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 1 (week 1)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 1 (week 1)
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Measured: 2.5 weeks (or after treatment session 5)
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Measured: 5 weeks (or after treatment session 10)
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Measured: 2.5 weeks (or after treatment session 5)
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Measured: 12 week follow up
PTSD Checklist (PCL-C)
The PCL-C is a self report measure that evaluates att 17 PTSD criteria using a 5 point Likert scale.
Measured: 26 week follow up
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Measured: 5 weeks (or after treatment session 10)
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Measured: 12 Week follow up
Primary Care PTSD Screen (PC-PTSD)
The PC-PTSD is a four-item measure designed to screen for PTSD.
Measured: 26 Week follow up
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Measured: 2.5 weeks (or after treatment session 5)
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Measured: 5 weeks (or after treatment session 10)
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Measured: 12 Week follow up
Beck Depression Inventory-II (BDI-II)
This self report measure of depression contains 21 items that are rated on a 4 point scale.
Measured: 26 Week follow up
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Measured: 2.5 weeks (or after treatment session 5)
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Measured: 5 weeks (or after treatment session 10)
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Measured: 12 Week follow up
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
The IASMHS is a 24 item assessment of help-seeking attitudes. It includes the following three factors based on components of Ajzen's Theory of Planned Behavior: Psychological Openness, Help-seeking Propensity and Indifference to Stigma.
Measured: 26 Week follow up
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Measured: 2.5 weeks (or after treatment session 5)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Measured: 5 weeks (or after treatment session 10)
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Measured: 12 week follow up
Perceived Stigma Measure (PSS)
Stigma will be measured using a 5 question assessment scale.
Measured: 26 week follow up
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 2.5 weeks (or after treatment session 5)
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 5 weeks (or after treatment session 10)
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 12 Week follow up
Suicide Risk Assessment
Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 26 Week follow up
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Measured: 2.5 weeks (or after treatment session 5)
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Measured: 5 weeks (or after treatment session 10)
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Measured: 12 week follow up
Beck Anxiety Inventory (BAI)
The BAI is a self report measure consisting of 21 items designed to discriminate anxiety from depression.
Measured: 26 week follow up
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 2 (week 1)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 3 (week 2)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 4 (week 2)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 5 (week 2.5)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 6 (week 3)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 7 (week 4)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 8 (week 4)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 9 (week 5)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: Treatment session 10 (week 5)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 5 weeks (or after treatment session 10)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 2.5 weeks (or after treatment session 5)
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 12 week follow up
BASIS-24
To assess overall psychological pain and gives an indicator of overall wellness. Due to the nature of the questions, this is deemed to be of safety nature.
Measured: 26 week follow up
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 2 (week 1)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 3 (week 2)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 4 (week 2)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 5 (week 2.5)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 6 (week 3)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 7 (week 4)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 8 (week 4)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 9 (week 5)
Subjective Units of Distress (SUDs)
Ranging from 1 to 100, Subjective Units of Distress are gathered every 5 mintues during imaginal exposure to determine levels of distress and engagement in the situation.
Measured: Treatment session 10 (week 5)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 2 (week 1)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 3 (week 2)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 4 (week 2)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 5 (week 2.5)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 6 (week 3)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 7 (week 4)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 8 (week 4)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 9 (week 5)
Side Effects Questionnaire
The Side Effects Questionnaire is based on a revised version of the Simulator Sickness Questionnaire (SSQ) that will be used to measure general discomfort in both the VRET and PE conditions of the study.
Measured: Treatment session 10 (week 5)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 2 (week 1)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 3 (week 2)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 4 (week 2)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 5 (week 2.5)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 6 (week 3)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 7 (week 4)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 8 (week 4)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 9 (week 5)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: Treatment session 10 (week 5)
Intent to Attend
This is a measure to assess the intent to complete study procedures.
Measured: 2.5 weeks (or after treatment session 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011May 2014

First posted26 Oct 2011 (estimated)
Study startOct 2011
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (77)Papers the sponsor has linked to this study.
Other trials for Stress DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01459705
Sponsor's protocol ID: 112226
Other IDs: W81XWH-11-2-0007
Acronym: VRPE Extension
Status last verified: Nov 2015
First submitted: 24 Oct 2011
Last updated: 14 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052.
PubMed 16891607
Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22. doi: 10.4088/jcp.v62n0808.
PubMed 11561934
Koenen KC, Stellman JM, Stellman SD, Sommer JF Jr. Risk factors for course of posttraumatic stress disorder among Vietnam veterans: a 14-year follow-up of American Legionnaires. J Consult Clin Psychol. 2003 Dec;71(6):980-6. doi: 10.1037/0022-006X.71.6.980.
PubMed 14622073
Bryant RA, Moulds ML, Guthrie RM, Dang ST, Nixon RD. Imaginal exposure alone and imaginal exposure with cognitive restructuring in treatment of posttraumatic stress disorder. J Consult Clin Psychol. 2003 Aug;71(4):706-12. doi: 10.1037/0022-006x.71.4.706.
PubMed 12924676
Foa EB. Psychosocial treatment of posttraumatic stress disorder. J Clin Psychiatry. 2000;61 Suppl 5:43-8; discussion 49-51.
PubMed 10761678
Foa EB, Meadows EA. Psychosocial treatments for posttraumatic stress disorder: a critical review. Annu Rev Psychol. 1997;48:449-80. doi: 10.1146/annurev.psych.48.1.449.
PubMed 9046566
Carlson JG, Chemtob CM, Rusnak K, Hedlund NL, Muraoka MY. Eye movement desensitization and reprocessing (EDMR) treatment for combat-related posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):3-24. doi: 10.1023/A:1024448814268.
PubMed 9479673
Sherman JJ. Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials. J Trauma Stress. 1998 Jul;11(3):413-35. doi: 10.1023/A:1024444410595.
PubMed 9690185
Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003388. doi: 10.1002/14651858.CD003388.pub2.
PubMed 15846661
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.
PubMed 12182270
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
PubMed 2871574
Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7. doi: 10.1016/s0006-3223(00)00896-9.
PubMed 11074232
Shalev AY, Sahar T, Freedman S, Peri T, Glick N, Brandes D, Orr SP, Pitman RK. A prospective study of heart rate response following trauma and the subsequent development of posttraumatic stress disorder. Arch Gen Psychiatry. 1998 Jun;55(6):553-9. doi: 10.1001/archpsyc.55.6.553.
PubMed 9633675
Mason J, Southwick S, Yehuda R, Wang S, Riney S, Bremner D, Johnson D, Lubin H, Blake D, Zhou G, et al. Elevation of serum free triiodothyronine, total triiodothyronine, thyroxine-binding globulin, and total thyroxine levels in combat-related posttraumatic stress disorder. Arch Gen Psychiatry. 1994 Aug;51(8):629-41. doi: 10.1001/archpsyc.1994.03950080041006.
PubMed 8042912
Yehuda R. Post-traumatic stress disorder. N Engl J Med. 2002 Jan 10;346(2):108-14. doi: 10.1056/NEJMra012941. No abstract available.
PubMed 11784878

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With Post Traumatic Stress Disorder (PTSD)
ClinicalTrials.gov ID: NCT01459705
Acronym / sponsor ID: VRPE Extension / 112226
Conditions: Stress Disorders, Post-Traumatic Stress Disorder
Keywords: Combat Disorders, Exposure Therapy, Army Personnel
Study type: Interventional
Recruitment status: Completed
Enrolment: 162 participants (actual)
Lead sponsor: National Center for Telehealth and TechnologyUS federal agency
Collaborators: The Geneva Foundation
Study start: Oct 2011
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 26 Oct 2011 (estimated)
Results: Posted 14 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Prolonged Exposure Therapy (PE)	Active comparator	Behavioral: 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.
Virtual Reality Exposure Therapy (VRET)	Experimental	Behavioral: 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.
Waitlist	Placebo comparator	Behavioral: WaitlistThe waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prolonged Exposure Therapy (PE)Also: PEProlonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.	Behavioural	Prolonged Exposure Therapy (PE)
Virtual Reality Exposure Therapy (VRET)Also: VRE, VRETVirtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.	Behavioural	Virtual Reality Exposure Therapy (VRET)
WaitlistAlso: WL, Waitlist Control GroupThis group will refrain from psychotherapy until after the completion of the 5 weeks of study participation	Behavioural	Waitlist

Primary outcome

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.

82 secondary outcomes

PTSD Checklist- Civilian (PCL-C)
Time frame: Screening Visit (Day 1)
Primary Care PTSD Screen (PC-PTSD)
Time frame: Screening Visit (Day 1)
Beck Depression Inventory-II (BDI-II)
Time frame: Screening Visit(Day 1)
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Time frame: Screening Visit(Day 1)
Perceived Stigma Measure (PSS)
Time frame: Screening Visit(Day 1)
Suicide Risk Assessment
Time frame: Screening Visit(Day 1)
Beck Anxiety Inventory (BAI)
Time frame: Screening Visit(Day 1)
Behavior and Sympton Identification Scale (BASIS-24)
Time frame: Screening Visit(Day 1)
Intent to Attend
Time frame: Screening Visit (Day 1)
Subjective Units of Distress (SUDs)
Time frame: Treatment session 1 (week 1)
Side Effects Questionnaire
Time frame: Treatment session 1(week 1)
BASIS-24
Time frame: Treatment session 1 (week 1)
Intent to Attend
Time frame: Treatment session 1 (week 1)
PTSD Checklist (PCL-C)
Time frame: 2.5 weeks (or after treatment session 5)
PTSD Checklist (PCL-C)
Time frame: 5 weeks (or after treatment session 10)
Primary Care PTSD Screen (PC-PTSD)
Time frame: 2.5 weeks (or after treatment session 5)
PTSD Checklist (PCL-C)
Time frame: 12 week follow up
PTSD Checklist (PCL-C)
Time frame: 26 week follow up
Primary Care PTSD Screen (PC-PTSD)
Time frame: 5 weeks (or after treatment session 10)
Primary Care PTSD Screen (PC-PTSD)
Time frame: 12 Week follow up
Primary Care PTSD Screen (PC-PTSD)
Time frame: 26 Week follow up
Beck Depression Inventory-II (BDI-II)
Time frame: 2.5 weeks (or after treatment session 5)
Beck Depression Inventory-II (BDI-II)
Time frame: 5 weeks (or after treatment session 10)
Beck Depression Inventory-II (BDI-II)
Time frame: 12 Week follow up
Beck Depression Inventory-II (BDI-II)
Time frame: 26 Week follow up
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Time frame: 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)
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Time frame: 12 Week follow up
Inventory of Attitudes Toward Seeking Mental Health Services (IASMHS)
Time frame: 26 Week follow up
Perceived Stigma Measure (PSS)
Time frame: 2.5 weeks (or after treatment session 5)
Perceived Stigma Measure (PSS)
Time frame: 5 weeks (or after treatment session 10)
Perceived Stigma Measure (PSS)
Time frame: 12 week follow up
Perceived Stigma Measure (PSS)
Time frame: 26 week follow up
Suicide Risk Assessment
Time frame: 2.5 weeks (or after treatment session 5)
Suicide Risk Assessment
Time frame: 5 weeks (or after treatment session 10)
Suicide Risk Assessment
Time frame: 12 Week follow up
Suicide Risk Assessment
Time frame: 26 Week follow up
Beck Anxiety Inventory (BAI)
Time frame: 2.5 weeks (or after treatment session 5)
Beck Anxiety Inventory (BAI)
Time frame: 5 weeks (or after treatment session 10)
Beck Anxiety Inventory (BAI)
Time frame: 12 week follow up

Results and safety

Results posted to the registry on 14 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prolonged Exposure Therapy (PE)	54	32
Virtual Reality Exposure Therapy (VRET)	54	30
Waitlist	54	47

Primary outcome: Clinician-Administered PTSD Scale (CAPS)

Time frame: Screening Visit (Day 1). Mean (Standard Deviation). Unit: units on scale

Measure	Prolonged Exposure Therapy (PE) n = 54	Virtual Reality Exposure Therapy (VRET) n = 54	Waitlist n = 54
Value	78.28 (16.35)	80.44 (16.23)	78.89 (16.87)

Population analysed: Baseline scores on the CAPS-W (last week reference)

Primary outcome: Clinician-Administered PTSD Scale (CAPS)

Time frame: 2.5 weeks (or after treatment session 5). Mean (Standard Deviation). Unit: units on a scale

Measure	Prolonged Exposure Therapy (PE) n = 39	Virtual Reality Exposure Therapy (VRET) n = 36	Waitlist n = 52
Value	65.03 (29.19)	71.19 (23.27)	74.73 (21.78)

Population analysed: Participants who provided data at mid treatment

Primary outcome: Clinician-Administered PTSD Scale (CAPS)

Time frame: 5 weeks (or after treatment session 10). Mean (Standard Deviation). Unit: units on a scale

Measure	Prolonged Exposure Therapy (PE) n = 32	Virtual Reality Exposure Therapy (VRET) n = 30	Waitlist n = 47
Value	44.28 (33.73)	57.07 (32.32)	68.06 (24.27)

Prolonged Exposure Therapy (PE) vs Waitlist: Slope: -22.34
Virtual Reality Exposure Therapy (VRET) vs Waitlist: Slope: -13.30
Prolonged Exposure Therapy (PE) vs Virtual Reality Exposure Therapy (VRET): Slope: 9.04

Population analysed: Participants who provided outcome data at post treatment

Primary outcome: Clinician-Administered PTSD Scale (CAPS)

Time frame: 12 week follow up. Mean (Standard Deviation). Unit: units on a scale

Measure	Prolonged Exposure Therapy (PE) n = 27	Virtual Reality Exposure Therapy (VRET) n = 26
Value	36.63 (31.80)	55.88 (31.10)

Prolonged Exposure Therapy (PE) vs Virtual Reality Exposure Therapy (VRET): Slope: 15.07

82 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. From time of baseline visit to final follow up visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prolonged Exposure Therapy (PE)	0 of 54 (0%)	12 of 54 (22.2%)	Not reported
Virtual Reality Exposure Therapy (VRET)	3 of 54 (5.6%)	15 of 54 (27.8%)	Not reported
Waitlist	0 of 54 (0%)	0 of 54 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16891607Difede J, Cukor J, Patt I, Giosan C, Hoffman H. The application of virtual reality to the treatment of PTSD following the WTC attack. Ann N Y Acad Sci. 2006 Jul;1071:500-1. doi: 10.1196/annals.1364.052.
Background: PubMed 11561934Rothbaum BO, Hodges LF, Ready D, Graap K, Alarcon RD. Virtual reality exposure therapy for Vietnam veterans with posttraumatic stress disorder. J Clin Psychiatry. 2001 Aug;62(8):617-22. doi: 10.4088/jcp.v62n0808.
Background: PubMed 14622073Koenen KC, Stellman JM, Stellman SD, Sommer JF Jr. Risk factors for course of posttraumatic stress disorder among Vietnam veterans: a 14-year follow-up of American Legionnaires. J Consult Clin Psychol. 2003 Dec;71(6):980-6. doi: 10.1037/0022-006X.71.6.980.
Background: PubMed 12924676Bryant RA, Moulds ML, Guthrie RM, Dang ST, Nixon RD. Imaginal exposure alone and imaginal exposure with cognitive restructuring in treatment of posttraumatic stress disorder. J Consult Clin Psychol. 2003 Aug;71(4):706-12. doi: 10.1037/0022-006x.71.4.706.
Background: PubMed 10761678Foa EB. Psychosocial treatment of posttraumatic stress disorder. J Clin Psychiatry. 2000;61 Suppl 5:43-8; discussion 49-51.
Background: PubMed 9046566Foa EB, Meadows EA. Psychosocial treatments for posttraumatic stress disorder: a critical review. Annu Rev Psychol. 1997;48:449-80. doi: 10.1146/annurev.psych.48.1.449.
Background: PubMed 9479673Carlson JG, Chemtob CM, Rusnak K, Hedlund NL, Muraoka MY. Eye movement desensitization and reprocessing (EDMR) treatment for combat-related posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):3-24. doi: 10.1023/A:1024448814268.
Background: PubMed 9690185Sherman JJ. Effects of psychotherapeutic treatments for PTSD: a meta-analysis of controlled clinical trials. J Trauma Stress. 1998 Jul;11(3):413-35. doi: 10.1023/A:1024444410595.
Background: PubMed 15846661Bisson J, Andrew M. Psychological treatment of post-traumatic stress disorder (PTSD). Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003388. doi: 10.1002/14651858.CD003388.pub2.
Background: PubMed 12182270Resick 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.
Background: PubMed 2871574Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
Background: PubMed 11074232Delahanty DL, Raimonde AJ, Spoonster E. Initial posttraumatic urinary cortisol levels predict subsequent PTSD symptoms in motor vehicle accident victims. Biol Psychiatry. 2000 Nov 1;48(9):940-7. doi: 10.1016/s0006-3223(00)00896-9.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gregory A Gahm, PhD principal investigator

DCoE- National Center for Telehealth and Technology

Greg Reger, PhD principal investigator

DCoE - National Center for Telehealth and Technology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinician-Administered PTSD Scale (CAPS) (time frame: Screening Visit (Day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01459705, which also lists 77 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.