NCT06218381

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. 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. 2.To what extent are participants aware of the stimuli presented and tolerating the exposures?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
14mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress65%
Mar 2024Jul 2027

First Submitted

Initial submission to the registry

January 9, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

January 9, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

Post Traumatic Stress DisorderVeteranVery Brief Exposure

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

EXPERIMENTAL

This 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).

Other: Very Brief Exposure to Combat Images

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.

Image Exposure Arm

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Bradley M Peterson, MD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Courtney Marcelino

CONTACT

Bradley S Peterson, MD

CONTACT

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

Locations