The PREVENT Resilience Study
ConditionPsychological Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEmory University
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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 DSM-5 clusters.
Disqualifiers
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)
Trial design
Design model
Sequential
Treatments tested in this trial
Transcranial Magnetic Stimulation (TMS)
DeviceTranscranial 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.
TMS Sham
Other interventionTMS 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
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Transcranial Magnetic Stimulation (TMS)Experimental treatment 1 intervention
Group B: Control ApplicationSham comparator 1 intervention
Trial outcomes
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 interventionSecondary 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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov