ClinicalTrials.gg
RecruitingNCT07568145Updated Sep 8, 2026

The PREVENT Resilience Study

An interventional study of Transcranial Magnetic Stimulation (TMS) and TMS Sham in Psychological Trauma, sponsored by Emory University. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Emory University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 51 studies in Psychological Trauma with a site in United States — 12 open to participants now, 15 under way, none of them phase 3. Psychological Trauma · United States.

Planned enrollment
30th of 42
50 · median 89
Started
2026
with 2 others
No phase
40 of 51
10 open now
Primary completion
2028-03
later than 13 of 14 live
Registered
49th of 51
by date

Among the 51 studies in Psychological Trauma with a site in United States, this one is the 30th largest by planned enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2026, is one of 40 with no phase, reaches primary completion later than 13 of the 14 other live ones, and was the 49th registered.

Psychological Trauma

140 studies on the registry are indexed under Psychological Trauma; 43 are open to participants now.

Browse Psychological Trauma studies →

Open to participants now

12 of the 51 studies in Psychological Trauma with a site in United States are open now. Recruiting first, the newest first:

6 more — sign in →

All 12 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 28 Psychological Trauma studies recruiting now, 12 (43%) set no upper age limit and 14 (50%) stop at 75 or younger; 9 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study summary

PTSD is one of the most universal and severe psychiatric disorders whose incidence continues to rise due to the common exposure to severe trauma in the United States and worldwide. After trauma, a proportion of individuals maintains high symptoms of PTSD and depression, which can persist for years. The early weeks following trauma present a unique opportunity to deliver early interventions that can prevent chronic PTSD and depression from occurring, and the researchers propose a brain-based intervention that will reduce reactivity to threat, an early risk mechanism for chronic PTSD. This study is being done to learn more about whether brain stimulation in the weeks after a trauma can change brain activity that is linked to Post-Traumatic Stress Disorder (PTSD).

Read the detailed description

After experiencing a traumatic event, there is a risk of developing Post-Traumatic Stress Disorder, which can disrupt everyday life and functioning. It is now well-recognized that many individuals experience initial psychological symptoms acutely following a traumatic event, but many recover naturally within the first 3 months post-trauma. However, about 20% of individuals continue to maintain high levels of debilitating symptoms that can persist for years following the trauma in the absence of treatment. Initial hyperarousal is a predictor of subsequent re-experiencing and avoidance symptoms. Such chronic symptoms present the greatest burden to individuals, associated with increasingly ingrained behavioral responses such as avoidance, decreasing quality of life, and the physiological consequences of chronic allostatic load, including cardiovascular and metabolic disorders. The burden to society is similarly tremendous, and annual costs associated with chronic post-trauma psychopathology are estimated to exceed $230 billion.

Interventions in the early post-trauma period could therefore provide an immense benefit to society by enhancing mechanisms that lead to recovery and resilience, thereby reducing chronic trauma-related psychopathology. This study is being done to test Transcranial Magnetic Stimulation (TMS) for early intervention for Post-Traumatic Stress Disorder. Researchers will test TMS in the weeks following a psychological trauma among individuals experiencing symptoms associated with acute stress. This usage of TMS is experimental. The study is being done to learn more about whether brain stimulation in the weeks after a trauma can change brain activity that is linked to Post-Traumatic Stress Disorder.

03

Conditions studied

  • Psychological Trauma

Keywords

  • Post-Traumatic Stress Disorder
  • Transcranial Magnetic Stimulation (TMS)
  • Resilience
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women 18-65 years of age. (Assessed via self-reported and medical record-based Date of Birth)
  • Trauma-exposed within the last 2 weeks (Endorsement of having experienced an event that could have caused death, serious injury, or sexual violence)
  • High initial symptoms of PTSD related to the index trauma - PCL-5 >30 AND at least 2 symptoms of hyperarousal.
  • Low symptoms of PTSD related to a previous lifetime trauma - PCL-5\<31AND does not meet for all four clusters.
  • Participants may be on psychotropic medication, including antidepressants, antipsychotics, benzodiazepines and anticonvulsants, but the dosage of the medication must be stable for at least 6 weeks and not change during the course of the study (Assessed via self-report during the screening phone call).
  • Capable and willing to provide .

Exclusion criteria

Exclusion Criteria:

  • Having active suicidal intent or plan, or in the clinician's opinion, is likely to attempt suicide within the next six months. (Assessed via the Patient Health Questionnaire-9 (PHQ-9) during the screening phone call)
  • Lifetime diagnosis of psychotic disorder or bipolar disorder per psychiatric screener. (Assessed via self-report during the screening phone call)
  • Diagnosed with the following conditions: a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in the central nervous system (CNS), stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness for more than 5 minutes due to head injury (Assessed via self-report during the screening phone call)
  • History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, intracranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes), or implanted medical pumps. (Assessed via self-report during the screening phone call)
  • For women, being pregnant. (Assessed via self-report during the screening phone call, the medical record, and cycling females will undergo a pregnancy test at TMS Day 1)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Transcranial Magnetic Stimulation (TMS)

    All participants will complete two days that will contain both neuroimaging and TMS components and will take approximately 4 hours. Some TMS components will consist of active TMS, and other TMS components will consist of sham (placebo) TMS.

    Device: Transcranial Magnetic Stimulation (TMS)

  • Sham comparator
    Control Application

    All participants will experience multiple single-blind sham control TMS sessions (30-minute sessions) and post-sham MRI scan.

    Other: TMS Sham

Interventions

  • DeviceTranscranial Magnetic Stimulation (TMS)

    Transcranial Magnetic Stimulation (TMS) is a non-invasive, FDA-approved procedure for pharmaco-resistant depression and is widely used in clinical and research settings. It uses magnetic pulses to stimulate underactive nerve cells in the brain, primarily treating depression and obsessive-compulsive disorder (OCD) when other treatments fail. It is a safe, outpatient treatment, usually involving a 20-40 minute session.

  • OtherTMS Sham

    TMS Sham is equivalent to a drug placebo. The experience is the same with the noise and vibration of the TMS coil, however, no magnetic stimulation occurs. Participants will be blinded to the condition during the TMS days to prevent bias in responding during the MRI tasks

06

What researchers measure

Primary outcomes

  1. Amygdala Reactivity During Fear Processing Pre- to Post TMS

    Amygdala reactivity during fear processing will be assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala will be separated into the right and left hemispheres. The right amygdala is the primary outcome measure. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. For analysis of amygdala reactivity to threat cues, volume-averaged beta values for each condition (fearful faces, neutral faces) will be extracted. Right amygdala threat reactivity will be compared between receiving any versus no TMS

    Time frame: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention

Secondary outcomes

  1. Response assessment of amygdala threat reactivity for different doses

    Change in amygdala threat reactivity, defined as blood oxygen level-dependent (BOLD) response to threat-related stimuli measured by functional magnetic resonance imaging (fMRI), comparing different doses of TMS.

    Time frame: Baseline, day 1 post-TMS intervention and day 2 post-TMS intervention

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The research team will share Individual Participant data that has been deidentified with the National Institute of Mental Health (NIMH) Data Archive (DA) as per the terms of the grant

Time frame: Data will become available after the study and will follow the standard NDA access rules

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Mar 2028, 21 months after the start.

Of 82 non-industry interventional studies with no phase under Psychological Trauma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 46. This study's planned 21 months is below that.

Counting every sponsor, half of 83 studies reached it within 24 months; a quarter within 12 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 5, 2026
StartActual
Jun 18, 2026
Primary completionEst.
Mar 2028
CompletionEst.
Mar 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07568145
Lead sponsor
Emory University
Responsible party
Sanne van Rooij (Associate Professor, Emory University) — Principal investigator
First posted
May 5, 2026
Start date
Jun 18, 2026
Primary completion
Mar 2028 (estimated)
Completion
Mar 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Sanne van Rooij, PhD
Contact
sanne.van.rooij@emory.edu
404-251-8926
Sanne van Rooij, PhD
principal investigator · Emory University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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