D-cycloserine and Virtual Reality Exposure to Treat Iraq War Veterans With PTSD

Conditions

Stress Disorder, Post Traumatic

Keywords

D-Cycloserine, Virtual Reality, Exposure Therapy, Veterans, Cognitive Behavior Therapy, Translational Research

Brief summary

This study will determine whether a combination of virtual reality exposure therapy and D-cycloserine will reduce post-traumatic stress disorder symptoms in Iraq war veterans.

Detailed description

Post-traumatic stress disorder (PTSD) is a type of anxiety disorder affecting people who have witnessed or experienced a traumatic event. Veterans of war are at an increased risk for developing PTSD because of their experiences with war and combat. Symptoms of PTSD often include flashbacks or nightmares, depression, anxiety or uneasiness, and feeling emotionally numb or distant toward others. Fortunately, PTSD can be treated, usually with some combination of anti-depressants, anti-anxiety medication, and therapy. Virtual reality exposure (VRE) therapy is a new type of treatment that helps people to overcome anxiety about trauma by facing situations with the use of virtual reality. D-cycloserine is a medication that has been found to enhance the effects of psychotherapy in recent studies. This study will determine the effectiveness of VRE therapy plus D-cycloserine at reducing PTSD symptoms in Iraq war veterans. During this study, all participants will undergo one educational session and five VRE sessions. The first session will involve gathering information, learning common reactions to trauma, and participating in a breathing relaxation approach. The following five sessions will involve reviewing memories of Iraq and watching virtual Iraq sequences. Each participant will wear a head-mounted display during which they will view scenario settings such as cities, humvee convoys, and scenes related to combat. Participants will be randomly assigned to receive D-cycloserine, alprazolam (anti-anxiety drug), or placebo one half-hour before each VRE session. Prior to the first treatment session, participants will undergo a startle reaction procedure. This will entail hearing sudden tones that last a fraction of a second, and viewing virtual reality scenes. Three small electrodes, attached to each participant's face, will measure the number of eye blinks during the procedure. At several times throughout the study, heart rate and skin conductance will also be measured with electrodes. Collection of saliva samples and measurement of blood pressure will also occur several times during this study. Before, during, and immediately after treatment, participants will complete questionnaires. Participants will be contacted 3, 6, and 12 months after treatment to assess symptoms and to schedule a time for an interview, additional questionnaires, and the virtual reality-based assessment.

Related papers

No related papers found yet.

Interventions

DRUGD-Cycloserine

D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

DRUGAlprazolam

Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.

BEHAVIORALVirtual Reality Exposure Therapy

VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.

DRUGPlacebo

Placebo will be administered in the same manner as the active drugs.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Meets DSM-IV criteria for PTSD due to Iraq military trauma * Speaks English * Healthy overall

Exclusion criteria

* History of mania, schizophrenia, or other psychoses * Suicidal * Current alcohol or drug dependence * Medication free within 2 weeks of study entry for any medication that has been taken less than daily for the past month and medicine free within 4 weeks of study entry for any anxiolytic medication that has been taken daily for the last month or more * Pregnant * Special medical conditions, such as kidney insufficiency, chronic diseases, or history of significant head injury * Stabilized on potentially data obscuring medication such as glucocorticoids

Design outcomes

Primary

Measure	Time frame	Description
Clinician-Administered PTSD Scale (CAPS)	Baseline	Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

Secondary

Measure	Time frame	Description
PTSD Symptom Scale Self-Report	Baseline	PTSD Symptom Scale - Self-Report Version (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of PTSD. Each of the 17 items describe PTSD symptoms which respondents rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Ratings on items are summed to create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score (that ranges from 0 to 51). The total score higher than 13 indicates on likelihood of PTSD.

Countries

United States

Participant flow

Recruitment details

Participants were self-referred or referred by professionals. Some patients were referred from both VA personnel and non-VA sources between January 2007-May 2013.

Participants by arm

Arm	Count
VRE Therapy and D-cycloserine D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session. Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.	53
VRE Therapy and Alprazolam Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session. Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.	50
VRE Therapy and Placebo Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display. Placebo: Placebo will be administered in the same manner as the active drugs.	53
Total	156

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Withdrawal by Subject	25	15	19

Baseline characteristics

Characteristic	VRE Therapy and D-cycloserine	VRE Therapy and Alprazolam	VRE Therapy and Placebo	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	53 Participants	50 Participants	53 Participants	156 Participants
Region of Enrollment United States	53 participants	50 participants	53 participants	156 participants
Sex: Female, Male Female	4 Participants	1 Participants	3 Participants	8 Participants
Sex: Female, Male Male	49 Participants	49 Participants	50 Participants	148 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 53	0 / 50	0 / 53
serious Total, serious adverse events	0 / 53	0 / 50	0 / 53

Outcome results

Primary

Clinician-Administered PTSD Scale (CAPS)

Scores may range from 0 (no symptoms) to 136 (severe symptoms). The score is based on the first 17 CAPS items administered.

Time frame: Baseline