NCT00978484

Brief Summary

Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD symptoms than does similar therapy that uses a simple, static, computer image.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

June 30, 2014

Status Verified

June 1, 2014

Enrollment Period

5 years

First QC Date

September 16, 2009

Last Update Submit

June 27, 2014

Conditions

Post Traumatic Stress Disorder

Keywords

PTSDDepressionAnxietyVirtual RealityComputer TherapyExposure TherapyProlonged ExposureMilitary MedicineCombatIraqAfghanistanAir Force PersonnelArmed Forces PersonnelArmy PersonnelCoast Guardpsychologymilitary psychiatrycombat disorderscombat neurosisMarinesMilitaryNavy PersonnelSailorsSoldiers

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PSTD Scale (CAPS)

    Post Tx, and 3 month follow up

Secondary Outcomes (7)

  • PTSD Checklist, Military Version (PCL-M):

    Post Tx, and 3 month follow up

  • The Patient Health Questionnaire 9 (PHQ-9):

    same

  • Beck Anxiety Inventory (BAI):

    same

  • Behavioral Reactivity Test (BRT)

    same

  • Automated Neuropsychological Assessment Metric (ANAM)

    same

  • +2 more secondary outcomes

Study Arms (2)

Static Virtual Reality

ACTIVE COMPARATOR

Exposure Therapy using a still computer image

Behavioral: Augmented Exposure Therapy

Dynamic Virtual Reality

EXPERIMENTAL

Virtual Reality Exposure Therapy using full, immersive Virtual Reality

Behavioral: Virtual Reality Exposure Therapy - Dynamic

Interventions

Virtual Reality Exposure Therapy - DynamicBEHAVIORAL

10 weeks of Virtual Reality Exposure using full, immersive VR

Also known as: VRE, VRET
Dynamic Virtual Reality
Augmented Exposure TherapyBEHAVIORAL

Exposure Therapy augmented with a still computer image

Also known as: AET, Static VRE, Prolonged Exposure, PE
Static Virtual Reality

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be eligible to receive care at NMCSD or Camp Pendleton, willing and able to give informed consent, aged 18 to 60, have a PTSD diagnosis from combat operations in Iraq or Afghanistan based on DSM-IV criteria and Clinician Administered PTSD Scale (CAPS) score greater than 40, have an index trauma that occurred in Iraq or Afghanistan, be medically able to tolerate exposure treatment and physically able to don virtual reality headset and physiological monitoring equipment as assed by their medical provider, be willing and able to give up alcohol and/or other intoxicating substances within 12 hours of a VR treatment session, and be able to see, hear, and smell

You may not qualify if:

  • Subjects would be excluded or dropped from the study if they exhibit psychosis, mania, epilepsy, have current suicidal intent, are less than 30 days from a psychiatric hospitalization or suicide attempt, meet criteria for current, active substance dependence, use an intoxicating substance within 12 hours of a treatment session, or have another condition or event that the treating provider or medical monitor consider to be a safety hazard within the study. Subjects may also drop out of the study at any point with the assurance that they will be referred to other care as needed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Camp Pendlton

Camp Pendlton, California, United States

Location

Naval Medical Center San Diego (NMCSD)

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressionAnxiety DisordersCombat Disorders

Interventions

beta-Aminoethyl Isothiourea

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

ThioureaUreaAmidesOrganic ChemicalsSulfur Compounds

Study Officials

  • Robert N McLay, MD/PhD

    United States Naval Medical Center, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

June 30, 2014

Record last verified: 2014-06

Locations

US(2)