The Effects of Very Brief Exposure on PTSD in U.S. Combat Veterans
ConditionPost Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorChildren's Hospital Los Angeles
About this trial
The goal of this clinical trial is to develop a new behavioral treatment for U.S. combat veterans with post-traumatic stress disorder (PTSD), very brief exposure to combat-related stimuli. The main questions it aims to answer are:
1. How does Very Brief Exposure (combat images and control everyday images) and Visible Exposure to combat stimuli affect brain activity and subjective fear ratings? 2. To what extent are participants aware of the stimuli presented and tolerating the exposures?
All participants will view both very brief exposure and visible exposure to combat stimuli in the functional magnetic brain imaging (fMRI) scan. They will provide ratings of fear, awareness, and tolerability. Researchers will compare U.S. combat veterans with PTSD and healthy controls to confirm differences in brain region activation and ratings.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females ages 18-50
Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnosis of PTSD
Traumatic event is a combat-based experience (e.g., being injured, watching a buddy be killed)
Minimum score of 18 on the Combat Experience Scale (CES)
Disqualifiers
Treatment for PTSD, substance abuse, or mental health concerns in the past 6 months
10 or more years since the combat trauma
Acute intoxication
Severe level of Substance Dependence (6 or more DSM-V symptoms)
Trial design
Design model
Single group
Treatments tested in this trial
Very Brief Exposure to Combat Images
Other interventionIn VBE, a series of pictures representing a person's fears (e.g., a combat scene with arousing visuals) is presented very briefly (17 ms), followed by a masking stimulus that prevents conscious recognition of each picture. This sequence of picture-mask stimuli is repeated many times in an exposure session.
Treatment groups
90 Participants
are divided into 1 treatment groupGroup A: Image Exposure ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Activation of Frontostriatal and Prefrontal Brain Regions to combat stimuli in PTSD
A hypothesis-driven, group-level analysis will test brain activity, measured as Blood Oxygen Level Dependent (BOLD) response, in 4 regions of interest while minimizing Type II error.
Time frame
Day 2Secondary outcomes
1
Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale
After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear".
Time frame
Day 22
Fear induced by exposure to combat stimuli in PTSD in healthy participants as measured by fear scale
After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear".
Time frame
Day 23
Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale
After each block of 10 combat stimuli trials, participants rate levels of fear on a 10-point, 1-10 visual analogue scale with these anchor point: "1 - No fear", "5 - Moderate but Tolerable Fear", and "10 - Very Intense Fear".
Time frame
Days 3-7Sponsors and contacts
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Source ClinicalTrials.gov