Stress Disorders, Post TraumaticVRPENCT01193725

Exposure Therapy for Active Duty Soldiers With Post Traumatic Stress Disorder

A study testing Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET) and Waitlist in people with Stress Disorders, Post Traumatic, 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

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Stress Disorders, Post Traumatic
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: Mar 2009to Nov 2014
Phase: Interventional
Are there results?: None posted in the registry

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 OIF/OEF
non sexually based deployment related trauma
three or more months since index trauma
stable on psychotropic medications 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

Trial locations and contacts

1 site in 1 country.

United States1 site

National Center for Telehealth and Technology
Tacoma, Washington, 98431

Other trials in United States

About this study

Official title: Comparing Virtual Reality Exposure Therapy to Prolonged Exposure in the Treatment of Soldiers With PTSD

This study is evaluating the efficacy of virtual realty 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 hypotheses 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
Being tested: Prolonged Exposure Therapy (PE), Virtual Reality Exposure Therapy (VRET), Waitlist
Keywords: Combat Disorders, Exposure Therapy, Army Personnel
Medical subject headings: 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 NCT01193725
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 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.
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.
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.
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.
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.
Measured: 26 Week follow-up

Secondary outcomes (70)

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: 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)
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)
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)
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)
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: 2.5 weeks (or after treatment session 5)
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 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 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: 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: 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: 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)

Timeline

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

Mar 2009Nov 2014

First posted2 Sep 2010 (estimated)
Study startMar 2009
Primary completionNov 2013
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (84)Papers the sponsor has linked to this study.
Other trials for Stress Disorders, Post TraumaticStudies 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: NCT01193725
Sponsor's protocol ID: CDO-09-8014
Other IDs: W81XWH-08-2-0015
Acronym: VRPE
Status last verified: Apr 2015
First submitted: 30 Aug 2010
Last updated: 14 Apr 2015
Results posted: No
Data monitoring committee: Yes

Publications

Rothbaum BO, Hodges LF. The use of virtual reality exposure in the treatment of anxiety disorders. Behav Modif. 1999 Oct;23(4):507-25. doi: 10.1177/0145445599234001.
PubMed 10533438
Pole N. The psychophysiology of posttraumatic stress disorder: a meta-analysis. Psychol Bull. 2007 Sep;133(5):725-46. doi: 10.1037/0033-2909.133.5.725.
PubMed 17723027
Jaycox LH, Foa EB, Morral AR. Influence of emotional engagement and habituation on exposure therapy for PTSD. J Consult Clin Psychol. 1998 Feb;66(1):185-92. doi: 10.1037//0022-006x.66.1.185.
PubMed 9489273
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
Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47.
PubMed 18052556
Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
PubMed 15229303
Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
PubMed 7492257
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
Simms LJ, Watson D, Doebbeling BN. Confirmatory factor analyses of posttraumatic stress symptoms in deployed and nondeployed veterans of the Gulf War. J Abnorm Psychol. 2002 Nov;111(4):637-47. doi: 10.1037//0021-843x.111.4.637.
PubMed 12428777
Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
PubMed 16507803
Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82. doi: 10.1001/archinte.167.5.476.
PubMed 17353495
Bryant RA. Cognitive behavior therapy of violence-related posttraumatic stress disorder. Aggression and Violent Behavior. 2000;5:79-97.
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

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?

See locations

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

All Stress Disorders, Post Traumatic trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 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 PTSD
ClinicalTrials.gov ID: NCT01193725
Acronym / sponsor ID: VRPE / CDO-09-8014
Conditions: Stress Disorders, Post Traumatic
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: University of Southern California
Study start: Mar 2009
Primary completion: Nov 2013 (actual)
Study completion: Nov 2014 (actual)
First posted: 2 Sep 2010 (estimated)
Results: Not posted in the source record

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 OIF/OEF
non sexually based deployment related trauma
three or more months since index trauma
stable on psychotropic medications 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 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.
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.
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.
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.
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.

70 secondary outcomes

PTSD Checklist (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)
BASIS-24
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)
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)
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: 2.5 weeks (or after treatment session 5)
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
Beck Anxiety Inventory (BAI)
Time frame: 26 Week Follow-up
BASIS-24
Time frame: Treatment session 1(week 1)
BASIS-24
Time frame: Treatment session 2(week 1)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
Background: PubMed 10533438Rothbaum BO, Hodges LF. The use of virtual reality exposure in the treatment of anxiety disorders. Behav Modif. 1999 Oct;23(4):507-25. doi: 10.1177/0145445599234001.
Background: PubMed 17723027Pole N. The psychophysiology of posttraumatic stress disorder: a meta-analysis. Psychol Bull. 2007 Sep;133(5):725-46. doi: 10.1037/0033-2909.133.5.725.
Background: PubMed 9489273Jaycox LH, Foa EB, Morral AR. Influence of emotional engagement and habituation on exposure therapy for PTSD. J Consult Clin Psychol. 1998 Feb;66(1):185-92. doi: 10.1037//0022-006x.66.1.185.
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 18052556Difede J, Cukor J, Jayasinghe N, Patt I, Jedel S, Spielman L, Giosan C, Hoffman HG. Virtual reality exposure therapy for the treatment of posttraumatic stress disorder following September 11, 2001. J Clin Psychiatry. 2007 Nov;68(11):1639-47.
Background: PubMed 15229303Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.
Background: PubMed 7492257Kessler RC, Sonnega A, Bromet E, Hughes M, Nelson CB. Posttraumatic stress disorder in the National Comorbidity Survey. Arch Gen Psychiatry. 1995 Dec;52(12):1048-60. doi: 10.1001/archpsyc.1995.03950240066012.
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 12428777Simms LJ, Watson D, Doebbeling BN. Confirmatory factor analyses of posttraumatic stress symptoms in deployed and nondeployed veterans of the Gulf War. J Abnorm Psychol. 2002 Nov;111(4):637-47. doi: 10.1037//0021-843x.111.4.637.
Background: PubMed 16507803Hoge CW, Auchterlonie JL, Milliken CS. Mental health problems, use of mental health services, and attrition from military service after returning from deployment to Iraq or Afghanistan. JAMA. 2006 Mar 1;295(9):1023-32. doi: 10.1001/jama.295.9.1023.
Background: PubMed 17353495Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the war back home: mental health disorders among 103,788 US veterans returning from Iraq and Afghanistan seen at Department of Veterans Affairs facilities. Arch Intern Med. 2007 Mar 12;167(5):476-82. doi: 10.1001/archinte.167.5.476.

Related trials for Stress Disorders, Post Traumatic

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder

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 Apr 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 NCT01193725, which also lists 84 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 Apr 2015.