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

• Status: Withdrawn
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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. 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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United States Army Institute of Surgical Research
• Treatments: Cycloserine

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.