NCT00855153

Brief Summary

The purpose of this pilot study is to begin the examination of the feasibility of using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) in the management of posttraumatic psychological symptoms in burned OIF/OEF military combatants. The purpose of a feasibility study is to determine if there is clinical utility in this proposed treatment and to establish effective and safe treatment procedures. Given current literature, the following hypotheses are generated: Hypothesis 1: Virtual Reality Exposure and D-Cycloserine medication (VRE + DCS learning pill) will result in clinically meaningful PTSD symptom reduction.

  1. 1.SMs will attain scores that are lower than initial measures for symptoms of PTSD
  2. 2.By the completion of VRE, Ss will attain scores in the sub-clinical range for measures of clinical depression Hypothesis 2: SMs will report greater life satisfaction following completion of VR+DCS treatment, as measured by scores on the Quality of Life Inventory (QOLI) when compared to pre-treatment scores

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

2.5 years

First QC Date

March 3, 2009

Last Update Submit

December 19, 2011

Conditions

Psychological Trauma

Keywords

PTSDburnsvirtual reality exposureD-CycloserineCombat related psychological trauma in burned servicemembers

Outcome Measures

Primary Outcomes (1)

  • Reduction in PTSD symptoms for burn patients and improve perceived life satifaction.

    12 weeks

Study Arms (1)

treatment

EXPERIMENTAL

Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment

Other: VR (Virtual reality)Drug: D-Cycloserine

Interventions

VR (Virtual reality)OTHER

VR stimulation of combat scenarios utilized as the exposure therapy tool.

Also known as: Iraq world II
treatment
D-CycloserineDRUG

50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment

Also known as: DCS
treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • You are an active duty military male or female service member 18-45 years old and able to participate for duration of care (estimated 12 weeks for initial examination to completion of treatment)
  • You have a diagnosis of Post Traumatic Stress Disorder (PTSD) based on a structured clinical interview
  • You have a score of greater than 40 on the Clinician Administered PTSD Scale (CAPS)

You may not qualify if:

  • Psychotic disorders such as schizophrenia, bipolar affective disorder, or history of disruptive non-compliant behaviors
  • Borderline intellectual functioning and attention memory problems as identified by standard USAISR neuropsychological screenings;
  • Major neurological or major medical difficulties, to include epilepsy/seizures or significant cardiovascular conditions such as heart or blood problems that would be dysregulated by increased anxiety exposure;
  • Dependent on drugs based upon screening, self-report or medical record;
  • Motion sickness as seen on the VR assessment trial.
  • Subjects screened with CAPS scores 44 or lower at pre-treatment assessment.
  • Women who are pregnant or breast feeding.
  • Unhealed uncovered wounds on face that would be a significant discomfort or infection risk
  • Open uncovered wound to hands or face that the doctor sees at being a moderate or greater risk for treatment complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

  • Davis M, Ressler K, Rothbaum BO, Richardson R. Effects of D-cycloserine on extinction: translation from preclinical to clinical work. Biol Psychiatry. 2006 Aug 15;60(4):369-75. doi: 10.1016/j.biopsych.2006.03.084.

    PMID: 16919524BACKGROUND

MeSH Terms

Conditions

Psychological TraumaStress Disorders, Post-TraumaticBurns

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Kathryn M Gaylord, RN, PhD

    US Army Institute of Surgical Research

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

May 1, 2009

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations

US(1)