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IRCT20180522039775N3 IRCT 2026-07-14 University of Birjand Effectiveness of repetitive transcranial magnetic stimulation (rTMS) on patients with comorbid anxiety-depression Effectiveness of right unilateral and sequential bilateral repetitive transcranial magnetic stimulation (rTMS) on somatic-subjective anxiety in patients with comorbid anxiety and depression 2026-07-31 anticipated 60 Complete https://irct.ir/trial/90325 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A computer-based randomization approach will be used (www.sealedenvelope.com). Sixty participants will be placed into ten equal-sized blocks of 6 to create a random allocation sequence. To conceal the randomization process, a unique code generated by the software will be provided to each participant. These codes will be randomly associated with cubes representing the intervention groups, Blinding description: In this study, both the evaluator and the therapist will remain blinded to the administration of active versus sham interventions, as well as to the group allocation of participants. Furthermore, participants will be unaware of whether they receive active or sham intervention, and the researcher will be blinded to group assignments. The evaluator will administer and score identical questionnaires at three time points—pretest, posttest, and follow-up—without any knowledge of group allocation. The therapist will receive and implement a standardized stimulation protocol (including duration, coil positioning, and audible coil click) for all participants, as provided by the researcher, while remaining uninformed about group assignment and underlying hypotheses. Both groups (active and sham stimulation) will be exposed to identical equipment, coil, acoustic artifact, and stimulation positioning, with the sole distinction that in the sham condition, no magnetic current will be delivered to the brain. N/A Mixed anxiety and depressive disorder. Intervention 1: Intervention group 1: In the bilateral stimulation protocol, the right dorsolateral prefrontal cortex (area F4) will be stimulated first at a frequency of 1 Hz. Each session will consist of 4 trains, each lasting 360 seconds, delivering a total of 1,440 pulses. Immediately thereafter, stimulation will be applied to the left dorsolateral prefrontal cortex (area F3) at a frequency of 10 Hz, such that each session comprises 75 trains of 5 seconds each, resulting in 3,750 pulses per session. The stimulation intensity for both hemispheres will be set at 120% of the resting motor threshold (rMT). All participants will receive repetitive transcranial magnetic stimulation (rTMS) sessions three times per week. Intervention 2: Intervention group 2: In the right unilateral stimulation group, all stimulation parameters applied to the right dorsolateral prefrontal cortex (DLPFC) will be identical to those used in the bilateral protocol (targeting region F4), except that the number of stimulation trains per session will be increased to five, resulting in the delivery of 1,800 pulses per session. All participants will receive repetitive transcranial magnetic stimulation (rTMS) sessions three times per week. Intervention 3: Control group: Sham repetitive transcranial magnetic stimulation (sham rTMS) will be administered to the same target regions (F3 and F4) using a placebo (sham) coil. This coil is fully matched to the active coil with respect to visual appearance, acoustic characteristics, and somatosensory perceptual features (e.g., a mild percussive sensation on the scalp). Critically, it lacks the capacity to generate focused magnetic field pulses and thus does not produce any neuromodulatory effect. No - There is not a plan to make this available Justification or reason for not sharing IPD is he participant data file is confidential and only general information will be entered in the article.
public Mehdi Rezaei
Sepideh Street
Birjand Iran (Islamic Republic of) 9719917569 +98 56 3220 5311 mehdi.rezaei15@birjand.ac.ir The University of Birjand scientific Mehdi Rezaei
Sepideh Street
Birjand Iran (Islamic Republic of) 9719917569 009832205311 mehdi.rezaei15@birjand.ac.ir University of Birjand Iran (Islamic Republic of) Patients who meet the criteria for major depressive disorder and an anxiety disorder according to the DSM-5 The symptoms of depression and a baseline score greater than 17 on the HRSD-17 scale Symptoms of anxiety and a baseline score greater than 18 on the HAMA scale Having access to medication information is available 18 years no limit Both Under 18 years old History of receiving electromagnetic therapies (such as tDCS, rTMS, ECT) Having significant suicidal thoughts The presence of a pacemaker or metal implants Personal history of seizures or epilepsy History of head surgery or severe head trauma Diagnosing other psychiatric conditions, including substance use disorders, organic brain disorders, personality disorders, or bipolar disorder Pregnancy or breastfeeding High-dose benzodiazepine use (>2 mg of lorazepam equivalent per day) F41.2 Mixed anxiety and depressive disorder Treatment - Devices Treatment - Devices Placebo Intervention group 1: In the bilateral stimulation protocol, the right dorsolateral prefrontal cortex (area F4) will be stimulated first at a frequency of 1 Hz. Each session will consist of 4 trains, each lasting 360 seconds, delivering a total of 1,440 pulses. Immediately thereafter, stimulation will be applied to the left dorsolateral prefrontal cortex (area F3) at a frequency of 10 Hz, such that each session comprises 75 trains of 5 seconds each, resulting in 3,750 pulses per session. The stimulation intensity for both hemispheres will be set at 120% of the resting motor threshold (rMT). All participants will receive repetitive transcranial magnetic stimulation (rTMS) sessions three times per week. Intervention group 2: In the right unilateral stimulation group, all stimulation parameters applied to the right dorsolateral prefrontal cortex (DLPFC) will be identical to those used in the bilateral protocol (targeting region F4), except that the number of stimulation trains per session will be increased to five, resulting in the delivery of 1,800 pulses per session. All participants will receive repetitive transcranial magnetic stimulation (rTMS) sessions three times per week. Control group: Sham repetitive transcranial magnetic stimulation (sham rTMS) will be administered to the same target regions (F3 and F4) using a placebo (sham) coil. This coil is fully matched to the active coil with respect to visual appearance, acoustic characteristics, and somatosensory perceptual features (e.g., a mild percussive sensation on the scalp). Critically, it lacks the capacity to generate focused magnetic field pulses and thus does not produce any neuromodulatory effect. Anxiety. Timepoint: Baseline, Final Treatment Session (Session 20), Three Months Post-Treatment (Follow-up). Method of measurement: Hamilton Anxiety Rating Scale (HAM-A). Depression. Timepoint: Baseline, Final Treatment Session (Session 20), Three Months Post-Treatment (Follow-up). Method of measurement: Hamilton Depression Rating Scale (HAM-D). University of Birjand Approved 2026-05-11 Research Ethics Committee of University of Birjand University of Birjand, Shahid Avini Boulevard Birjand South Khorasan Iran (Islamic Republic of)