The goal of this clinical trial is to learn if a combined treatment using repetitive transcranial magnetic stimulation (rTMS) and expressive writing works to reduce symptoms of post-traumatic stress in adults. It will also study how safe this treatment is and whether the timing of rTMS changes how well it works.
The main questions it aims to answer are:
* Does this combined treatment lower symptoms of post-traumatic stress? * Does it work better when rTMS is given before or after expressive writing?
Researchers will compare three groups to see which approach works best:
* rTMS given before expressive writing * rTMS given after expressive writing * Sham stimulation (a look-alike procedure that does not provide real stimulation)
Participants will:
* Take part in sessions that include expressive writing about emotional experiences * Receive either real rTMS or sham stimulation * Complete questionnaires about post-traumatic stress, anxiety, depression, and mood * Have their heart rate and skin responses measured during the sessions * Be assessed before the study, after the sessions, and one month later
This study includes adults aged 18 to 65 who have experienced at least one traumatic or highly stressful event and report symptoms of post-traumatic stress.
Be between 18 and 65 years of age.
Have experienced at least one traumatic or highly stressful event, regardless of how much time has passed since the event occurred.
Present a score ≥ 24 on the Revised Impact of Event Scale (IES-R).
Have post-traumatic stress symptoms that are not better explained by another clinical condition or mental disorder.
History of epilepsy, seizures, or convulsions.
Presence of intracranial or cranial metal incompatible with rTMS.
History of severe traumatic brain injury.
Pregnancy or reasonable possibility of pregnancy.
Parallel
Repetitive Transcranial Magnetic Stimulation
DevicerTMS will be administered by an experienced technician using a figure-of-eight coil connected to a Magstim Rapid2 stimulator (Magstim, Whitland, Dyfed, United Kingdom). Target localization will be performed using stereotactic neuronavigation with the frameless BrainSight system (Rogue Research, Canada) and a Polaris infrared tracking system (Northern Digital, Canada). Before each session and for each participant, the motor hotspot and resting motor threshold (rMT) will be determined. The hotspot will be defined as the stimulation site over the left primary motor cortex that produces the strongest and most consistent motor-evoked potentials in the first dorsal interosseous muscle, recorded via electromyography using a Biopac MP-35 system. The resting motor threshold will be defined as the minimum stimulation intensity capable of eliciting at least five small-amplitude motor responses out of ten stimuli applied to the relaxed muscle. The rTMS intensity will be individually adjusted
Expressive writing
BehavioralEmotional re-experiencing will be induced through expressive writing. Participants will write for 15 minutes once per week about the thoughts and emotions associated with their traumatic or highly stressful experiences throughout the treatment period (Pennebaker \& Chung, 2011).
Sham rTMS
DeviceSham stimulation will be delivered using a placebo coil that reproduces the acoustic and procedural characteristics of rTMS without producing effective cortical stimulation.
Post-traumatic stress symptoms
Post-traumatic stress symptomatology will be assessed using the Revised Impact of Event Scale (IES-R), a 22-item self-report instrument designed to measure subjective distress associated with traumatic or highly stressful events. The scale evaluates three core dimensions: intrusion, avoidance, and hyperarousal. In the present study, the IES-R will be used both to quantify the severity of post-traumatic stress symptoms and to establish eligibility criteria.
Adverse events
Safety will be described by the number of participants who experience adverse events (AEs) and serious adverse events (SAEs), as well as by the total number of AEs and SAEs observed. An adverse event is defined as any undesirable experience associated with the use of a medical product in a participant. A serious adverse event, according to the U.S. Food and Drug Administration (FDA), refers to any undesirable experience associated with a medical treatment that results in death, is life-threatening, requires hospitalization, leads to disability or permanent damage, necessitates intervention to prevent further harm, or results in any other significant medical consequence.
Anxiety
Anxiety symptomatology will be assessed using the Generalized Anxiety Disorder-7 questionnaire (GAD-7). The GAD-7 is a brief 7-item self-report scale designed to evaluate the severity of generalized anxiety symptoms.
Depression
Depressive symptomatology will be assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item self-report measure designed to evaluate the severity of depressive symptoms.
Positive and negative affect
Affect will be assessed using the Positive and Negative Affect Schedule (PANAS). The PANAS is a 20-item self-report scale composed of two 10-item subscales that measure positive affect and negative affect, respectively.
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Servicio Canario de Salud
Lead sponsor
University of La Laguna
Collaborator
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