NCT00992953

Brief Summary

It is proposed that using Virtual Reality as part of therapy will result in improvements in Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq and/or Afghanistan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
136

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2009

Completed
Last Updated

October 9, 2009

Status Verified

October 1, 2009

Enrollment Period

4.8 years

First QC Date

October 8, 2009

Last Update Submit

October 8, 2009

Conditions

Keywords

Virtual RealityPost Traumatic Stress DisorderCombatMilitaryMajor Depressive DisorderAnxietyVirtual Reality Exposure with Stimulus ControlTreatment as Usual

Study Arms (2)

Virtual Reality Therapy

EXPERIMENTAL

10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions

Behavioral: Virtual Reality Exposure with Stimulus Control

Treatment As Usual

ACTIVE COMPARATOR

Traditional Therapy and Psychiatric Medication

Behavioral: Treatment as Usual

Interventions

10 weeks of therapy and/or psychiatric medication as available

Also known as: TAU
Treatment As Usual

10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control

Also known as: Virtual Reality Gradual Exposure Treatment, VRGET, Virtual Reality Exposure, VRE
Virtual Reality Therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.
  • Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy

You may not qualify if:

  • Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naval Hosptial Camp Pendleton

Camp Pendlton, California, 92134, United States

Location

Naval Medical Center San Diego (NMCSD)

San Diego, California, 92134, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressive Disorder, MajorAnxiety Disorders

Interventions

TherapeuticsVirtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersDepressive DisorderMood Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brenda Wiederhold, PhD

    Virtual Reality Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

October 8, 2009

First Posted

October 9, 2009

Study Start

January 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 9, 2009

Record last verified: 2009-10

Locations