Psychological TraumaNCT00855153
Virtual Reality and D-Cycloserine in Combat Related Psycological Trauma in Burn Service Members
A study testing VR (Virtual reality) and D-Cycloserine in people with Psychological Trauma, run by United States Army Institute of Surgical Research at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Psychological Trauma
- What is being tested?
- VR (Virtual reality) and D-Cycloserine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Institute of Surgical Research
Fort Sam Houston, Texas, 78234
About this study
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
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:
Read more
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
Read the 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.
- Conditions
- Psychological Trauma
- Being tested
- VR (Virtual reality), D-Cycloserine
- Keywords
- PTSD, burns, virtual reality exposure, D-Cycloserine, Combat related psychological trauma in burned servicemembers
- Medical subject headings
- Psychological Trauma, Stress Disorders, Post-Traumatic, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR (Virtual reality)Other
Also called Iraq world II
VR stimulation of combat scenarios utilized as the exposure therapy tool.
D-CycloserineDrug
Also called DCS
50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Subjects receive 50mg DCS prior to 90 min session with graded VRE treatment Receives: Other: VR (Virtual reality); Drug: D-Cycloserine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in PTSD symptoms for burn patients and improve perceived life satifaction.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2009 (estimated)
- Study startMay 2009
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Investigator was not able to maintain IRB approval. Study never accrued subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Institute of Surgical Research
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kathryn M Gaylord, RN, PhD, Principal investigator, US Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00855153
- Sponsor's protocol ID
- H-09-012
- Status last verified
- Dec 2011
- First submitted
- 3 Mar 2009
- Last updated
- 20 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16919524
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00855153
- Acronym / sponsor ID
- H-09-012
- Conditions
- Psychological Trauma
- Keywords
- PTSD, burns, virtual reality exposure, D-Cycloserine, Combat related psychological trauma in burned servicemembers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator was not able to maintain IRB approval. Study never accrued subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Army Institute of Surgical ResearchUS federal agency
- Study start
- May 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 4 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Other: VR (Virtual reality), Drug: D-CycloserineSubjects receive 50mg DCS prior to 90 min session with graded VRE treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR (Virtual reality)Also: Iraq world IIVR stimulation of combat scenarios utilized as the exposure therapy tool. | Other | treatment |
| D-CycloserineAlso: DCS50 mg DCS 30 min prior to individual 90 min session with graded VR exposure treatment | Drug | treatment |
Primary outcome
Reduction in PTSD symptoms for burn patients and improve perceived life satifaction.
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
- Background: PubMed 16919524Davis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn M Gaylord, RN, PhD principal investigator
US Army Institute of Surgical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR (Virtual reality) and D-Cycloserine in people with Psychological Trauma, run by United States Army Institute of Surgical Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in PTSD symptoms for burn patients and improve perceived life satifaction. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00855153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2011.