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
Qualifiers
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 meeting for all four DSM-5 clusters.
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, intra-cranial 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
Treatments tested in this trial
- Transcranial Magnetic Stimulation (TMS)
- TMS Sham
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Emory University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov