The Effects of Very Brief Exposure on PTSD in U.S. Combat Veterans
PTSD
1 other identifier
interventional
80
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2024
CompletedFirst Posted
Study publicly available on registry
January 23, 2024
CompletedStudy Start
First participant enrolled
March 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
December 18, 2025
December 1, 2025
2.3 years
January 9, 2024
December 11, 2025
Conditions
Keywords
Outcome Measures
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.
Day 2
Secondary Outcomes (3)
Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale
Day 2
Fear induced by exposure to combat stimuli in PTSD in healthy participants as measured by fear scale
Day 2
Fear induced by exposure to combat stimuli in PTSD in veteran group as measured by fear scale
Days 3-7
Study Arms (1)
Image Exposure Arm
EXPERIMENTALThis within-subjects design study will have all participants view three types of exposure during fMRI scanning: VBE to combat images, VBE to masked everyday scenes (control), and conscious visible exposure to the same images (control).
Interventions
In 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.
Eligibility Criteria
You may qualify if:
- Patient Population
- 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)
- Minimum score of 3 or more on Primary Care (PC)-PTSD-5
- Participants with other cooccurring psychiatric disorders (e.g., anxiety, ADHD) will be included to ensure a representative sample.
- Healthy Population
- Males and Females, ages 18-50
You may not qualify if:
- Patient Population
- Treatment for PTSD, substance abuse, or mental health concerns in the past 6 months
- or more years since the combat trauma
- Acute intoxication
- Severe level of Substance Dependence (6 or more DSM-V symptoms)
- Prior diagnosis of Autistic Spectrum Disorders
- Current or past psychotic disorders or active psychotic symptoms
- Current Bipolar I Disorder
- Dementia
- Neurological or serious medical conditions (e.g., stroke, epilepsy/ seizure disorder, cancer, Lupus, HIV+);
- Traumatic brain injury
- Healthy Population
- Ferromagnetic implants (e.g., pacemaker), metal braces, retainers, tattoos or permanent make up w/ metallic content, transdermal medicinal patches that cannot be removed
- Neurological or serious medical conditions (e.g., stroke, epilepsy/ seizure disorder, cancer, Lupus, HIV+);
- Lifetime Diagnosis of PTSD, Tourette's Syndrome, Bipolar Disorder, Substance Dependence, Eating Disorder, Autism Spectrum Disorder, a psychotic disorder, Acute Stress Disorder
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain Imaging Lab
Los Angeles, California, 90027, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley M Peterson, MD
Children's Hospital Los Angeles
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Division of Child & Adolescent Psychiatry
Study Record Dates
First Submitted
January 9, 2024
First Posted
January 23, 2024
Study Start
March 22, 2024
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share