NCT00167804

Brief Summary

Combat related Posttraumatic Stress Disorder (PTSD) is the most common chronic psychiatric disorder in the veteran population. Unfortunately, outcome studies of VA PTSD programs have failed to show efficacy. VA PTSD patients have been significantly less responsive to conventional therapies than other PTSD populations. Virtual Reality based exposure therapy (VRE) allows patients to feel immersed in highly interactive computer-generated environments. Within these environments patients can be exposed to anxiety-provoking stimuli in a gradual and controlled manner so that they can become desensitized to these stimuli and, in the case of PTSD, the traumatic memories evoked by these stimuli. The advantages of VRE include less reliance on the patient's ability to visualize traumatic memories and making it more difficult for patients to avoid memories during exposure therapy. It is also safer and more convenient than in vivo exposure. In this study twenty Vietnam veterans are randomly assign to either VRE or to a Treatment as Usual (TAU) control condition. Treatment would consist of ten ninety-minute individual psychotherapy sessions for both groups. Assessments would occur at pre-treatment, immediate post-treatment and at six months post-treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

September 9, 2005

Last Update Submit

December 2, 2011

Conditions

Keywords

Exposure TherapyPost Traumatic Stress DisorderTreatment OutcomeVeteransVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Clinician Administered PTSD Scale

    Pre Tx, Post TX and 6 months Post Tx

Secondary Outcomes (1)

  • Mississippi-R Scale

    Pre Tx, Post TX and 6 months Post Tx

Study Arms (1)

1

OTHER

Present Centered Therapy focuses on the veterans problems in the here and now. It uses a problem solving approach and avoids discussion of war related traumatic events.

Behavioral: Virtual Reality Exposure

Interventions

VRE uses computer generated environments to conduct exposure therapy.

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Vietnam Veterans with combat related Posttraumatic Stress Disorder

You may not qualify if:

  • Active Substance Abuse
  • Psychosis
  • Bipolar Disorder
  • Dementia
  • Significant Cognitive Impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Medical Center, Decatur

Decatur, Georgia, 30033, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • David Ready, PhD MS

    VA Medical Center, Decatur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

December 6, 2011

Record last verified: 2011-12

Locations