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

Primary Purpose

Psychological Trauma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR (Virtual reality)
D-Cycloserine
Sponsored by
United States Army Institute of Surgical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Trauma focused on measuring PTSD, burns, virtual reality exposure, D-Cycloserine, Combat related psychological trauma in burned servicemembers

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 3, 2009
Last Updated
December 19, 2011
Sponsor
United States Army Institute of Surgical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00855153
Brief Title
Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator was not able to maintain IRB approval. Study never accrued subjects.
Study Start Date
May 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Institute of Surgical Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma
Keywords
PTSD, burns, virtual reality exposure, D-Cycloserine, Combat related psychological trauma in burned servicemembers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Description
Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment
Intervention Type
Other
Intervention Name(s)
VR (Virtual reality)
Other Intervention Name(s)
Iraq world II
Intervention Description
VR stimulation of combat scenarios utilized as the exposure therapy tool.
Intervention Type
Drug
Intervention Name(s)
D-Cycloserine
Other Intervention Name(s)
DCS
Intervention Description
50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
Primary Outcome Measure Information:
Title
Reduction in PTSD symptoms for burn patients and improve perceived life satifaction.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn M Gaylord, RN, PhD
Organizational Affiliation
US Army Institute of Surgical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
US Army Institute of Surgical Research
City
Ft Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16919524
Citation
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.
Results Reference
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Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members

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