Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation and Expressive Writing for Post-Traumatic Stress
Efficacy and Safety of a Combined Intervention of Repetitive Transcranial Magnetic Stimulation and Expressive Writing According to Timing of Administration: A Parallel-Group Randomized Controlled Trial in Adults With Post-Traumatic Stress Symptoms
1 other identifier
interventional
45
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2026
Shorter than P25 for not_applicable
2 active sites
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
First Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
Study Completion
Last participant's last visit for all outcomes
February 1, 2027
May 5, 2026
April 1, 2026
7 months
April 21, 2026
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Assessment at baseline, immediately after treatment and one month follow-up
Secondary Outcomes (5)
Adverse events
Through study completion, an average of 2 months
Anxiety
Assessment at baseline, immediately after treatment and one month follow-up
Depression
Assessment at baseline, immediately after treatment and one month follow-up
Positive and negative affect
Assessment immediately after every expressive writing session
Physiological arousal
From start to end of every expressive writing session
Study Arms (3)
rTMS applied 10 minutes after emotional re-experiencing through expressive writing (SG1)
EXPERIMENTALBoth experimental groups will receive the same excitatory repetitive transcranial magnetic stimulation (rTMS) protocol targeting the right dorsolateral prefrontal cortex (rDLPFC). The stimulation protocol will consist of: * Frequency: 10 Hz * Intensity: 80% of resting motor threshold * Train duration: 4 seconds * Inter-train interval: 11 seconds * 50 trains per session * Approximately 12 minutes per session * Total of 2,000 pulses per session Treatment will be administered five days per week over three weeks, for a total of 15 sessions and 30,000 pulses. Emotional 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. In this group, expressive writing will take place 10 minutes before the rTMS session.
rTMS applied 10 minutes before emotional re-experiencing through expressive writing (SG2)
EXPERIMENTALBoth experimental groups will receive the same excitatory repetitive transcranial magnetic stimulation (rTMS) protocol targeting the right dorsolateral prefrontal cortex (rDLPFC). The stimulation protocol will consist of: * Frequency: 10 Hz * Intensity: 80% of resting motor threshold * Train duration: 4 seconds * Inter-train interval: 11 seconds * 50 trains per session * Approximately 12 minutes per session * Total of 2,000 pulses per session Treatment will be administered five days per week over three weeks, for a total of 15 sessions and 30,000 pulses. Emotional 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. In this group, expressive writing will take place 10 minutes after the rTMS session.
Sham stimulation combined with expressive writing, divided equally to mirror the two active arms
SHAM COMPARATORSham stimulation will be delivered using a placebo coil that reproduces the acoustic and procedural characteristics of rTMS without producing effective cortical stimulation. Emotional 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. This group will be divided into two halves, each mirroring the timing conditions of each experimental study arm.
Interventions
rTMS 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
Emotional 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 stimulation will be delivered using a placebo coil that reproduces the acoustic and procedural characteristics of rTMS without producing effective cortical stimulation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Cochlear implants or internal pulse generators.
- Use of medication that lowers the seizure threshold.
- Current suicidal ideation or behaviour, or recent suicidal ideation within the past month.
- Other medical or psychiatric conditions that contraindicate the use of rTMS.
- Any condition that prevents participation in any of the study interventions.
- Currently receiving psychological and/or pharmacological treatment for PTSD, acute stress, or another disorder that could account for post-traumatic stress symptoms.
- Failure to provide written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Servicio Canario de Saludlead
- University of La Lagunacollaborator
Study Sites (2)
Instituto Universitario de Neurociencias (IUNE) de la Universidad de La Laguna (ULL)
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38200, Spain
Servicio de Evaluación del Servicio Canario de Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38109, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Lilisbeth Perestelo-Pérez, Doctor in Psychology
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- Participants will remain blinded to their experimental condition through the use of sham rTMS as the control intervention. In addition, the researchers responsible for participant selection, clinical assessment, and administration of the expressive writing task will not have access to the randomization sequence or group allocation, thereby maintaining participant and assessor blinding throughout the study. Participants will be instructed not to disclose information about the rTMS sessions, and assessors will avoid asking about sensations or details related to the stimulation. An independent statistician, not involved in data analysis, will generate the randomization sequence. The trial statistician conducting the analysis will remain blinded to treatment allocation until the database is locked and analysis is complete.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2026
First Posted
May 5, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
De-identified participant data, together with the statistical procedures used for analysis, will be made available as supplementary material in the final open-access publication of the study. The templates of all self-report measures used in the assessment will also be included. Participants will be informed of this procedure in the participant information sheet and will provide corresponding informed consent.