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Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members

This study has been withdrawn prior to enrollment.
(Investigator was not able to maintain IRB approval. Study never accrued subjects.)
Sponsor:
Information provided by (Responsible Party):
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00855153
First received: March 3, 2009
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

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. SMs will attain scores that are lower than initial measures for symptoms of PTSD
  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

Condition Intervention
Psychological Trauma
 Other: VR (Virtual reality)
Drug: D-Cycloserine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study Using Gradual Virtual Reality Exposure Therapy and D-Cycloserine (DCS) for Treatment of Combat Related Psychological Trauma in Burn Service Members

Resource links provided by NLM:

MedlinePlus related topics: Burns Injuries Wounds
Drug Information available for: Cycloserine
U.S. FDA Resources

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:
  • Reduction in PTSD symptoms for burn patients and improve perceived life satifaction. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: May 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment
Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment
 Other: VR (Virtual reality)
VR stimulation of combat scenarios utilized as the exposure therapy tool.
Other Name: Iraq world II
Drug: D-Cycloserine
50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
Other Name: DCS

Detailed Description:

The purpose of this study is to establish systematic observations about the feasibility of using gradual exposure virtual reality treatment and D-Cycloserine (VRE + DCS) with service members receiving medical care for burns attained during combat. The rational for this study comes from the need to establish with this population, when and how VRE + DCS might be delivered in a safe and systematic fashion. This would be done in preparation for the potential of a future controlled study to address the efficacy of VRE + DCS in comparison to each component and control group.

This study seeks to establish methods of applying VRE + DCS in relation to medical viability as an attempt to clarify at what stage of medical care a service member is able to give informed consent, follow the proscribed instructions, and participate in VRE+ DCS process to include reasonable attention and capacity for immersion. Other areas that will be examined include medication suitability, expected course of medical treatment that would allow for reasonable completion of twelve sessions within twenty weeks, and assessed stability in social support.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00855153

Locations
United States, Texas
US Army Institute of Surgical Research
Ft Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
United States Army Institute of Surgical Research
Investigators
Principal Investigator: Kathryn M Gaylord, RN, PhD US Army Institute of Surgical Research
  More Information

Publications:

Responsible Party: United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier: NCT00855153     History of Changes
Other Study ID Numbers: H-09-012
Study First Received: March 3, 2009
Last Updated: December 19, 2011
Health Authority: United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:
PTSD
burns
virtual reality exposure
D-Cycloserine
Combat related psychological trauma in burned servicemembers

Additional relevant MeSH terms:
Wounds and Injuries
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013