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IRCT20210611051543N1 IRCT 2021-08-05 Zanjan University of Medical Sciences The synergistic effect of repeated transcranial magnetic stimulation of the brain with cognitive behavior therapy in patients with panic disorder The Synergistic effect of repeated transcranial magnetic stimulation with cognitive behavioral therapy in patients with panic disorder 2021-07-13 anticipated 45 Complete https://irct.ir/trial/56877 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the finite randomization method of block randomization. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all blocks is equal and in this three-group experiment we will have 15 blocks (including 5 people in the first intervention group, 5 people in the second intervention group and 5 people in the control group). Randomization tool also uses random sequence generation software that these random sequence generation software in addition to simple structural randomization are able to generate random sequence by blocking method. For concealment, we use random allocation concealment, which is the method used to execute random sequences on study participants, so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, according to the order of entry of eligible participants to the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed, Blinding description: The subjects do not know the type of intervention. The patient receives the intervention in separate coded treatment rooms. No mirrors are installed on the patient's entrance and exit. Coding is done by one of the design partners. Patients do not see each other during the intervention. People who analyze the results do not know the nature of the study groups. The evaluation is done by someone other than the researcher. N/A Panic disorder. Intervention 1: Intervention group: The combination of repetitive transcranial magnetic stimulation of the brain and cognitive-behavioral therapy؛ The first session of cognitive-behavioral therapy, includes assessment and homework; session 2: assessment, socialization to treatment, medication and homework, session 3: assessment, interventions, medication and homework, session 4 includes assessment, behavioral interventions, medication and homework; sessions 5-8 include assessment, cognitive interventions, other interventions, medication and homework, sessions 9-10 include assessment, cognitive interventions, behavioral interventions, medication, and homework; sessions 11-12 include assessment, cognitive interventions, behavioral interventions, other interventions, and homework. Repetitive transcranial magnetic stimulation protocol: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks). Intervention 2: Intervention group: Repetitive transcranial magnetic stimulation: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks). Intervention 3: Control group: The control group received sham repetitive transcranial magnetic stimulation. Most of the parameters of the sham stimulation (frequency, pulses, stimulation site and intensity) were the same as for active stimulation. The sham stimulation was defined with a coil diverted by90 degrees over the same area and same intensity and design as real repetitive transcranial magnetic stimulation. An also cognitive-behavioral therapy applied in this group. Yes - There is a plan to make this available What will be shared: Outcomes and results are published in the form of statistics When: After publishing the article To whom: The data will be available to researchers Conditions: Can be used for secondary studies Where to obtain: 93Ma.hbi@zums.ac.ir 09147432754 How to obtain: Will be sent after receiving the email Comments:
public Maryam Habibi
Ark Square. Shahid Beheshti Hospital
zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 4001 93Ma.Hbi@zums.ac.ir Zanjan University of Medical Sciences scientific Maryam Habibi
Ark Square. Shahid Beheshti Hospital
Zanjan Iran (Islamic Republic of) 45136-15788 +98 24 3354 4001 93Ma.Hbi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) Having diagnostic criteria for Panic disorder based on psychiatrist diagnosis and clinical interview Having at least a third secondary education Experience at least 3 panic attacks per week Being 18 to 65 years old Signing the written consent form Not to be exposed to any psychological Therapies for at least 1 month before entering the research Not using alcohol and substances during the last month 18 years 65 years Both Inclusion complete criteria for personality disorder Existence of psychotic disorders, bipolar History of epilepsy and seizures No contraindications to repeated transcranial magnetic Stimulation, such as metal in the head or implanted brain medical Devices Diagnosis of any neurological conditions affecting central Nervous system(e.g. Parkinson's disease) Pregnancy Use of tricyclic antidepressants (TCAs) F41.0 Panic disorder [episodic paroxysmal anxiety] without agoraphobia Treatment - Devices Treatment - Devices Treatment - Devices Intervention group: The combination of repetitive transcranial magnetic stimulation of the brain and cognitive-behavioral therapy؛ The first session of cognitive-behavioral therapy, includes assessment and homework; session 2: assessment, socialization to treatment, medication and homework, session 3: assessment, interventions, medication and homework, session 4 includes assessment, behavioral interventions, medication and homework; sessions 5-8 include assessment, cognitive interventions, other interventions, medication and homework, sessions 9-10 include assessment, cognitive interventions, behavioral interventions, medication, and homework; sessions 11-12 include assessment, cognitive interventions, behavioral interventions, other interventions, and homework. Repetitive transcranial magnetic stimulation protocol: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks). Intervention group: Repetitive transcranial magnetic stimulation: 1 Hz transcranial magnetic stimulation to stimulate the right dorsolateral prefrontal cortex, 110% resting motor threshold, 1800 pulses (lasting for 30 minutes) in each session, and one session per day. Performed for 20 sessions (5 sessions per week for 4 weeks). Control group: The control group received sham repetitive transcranial magnetic stimulation. Most of the parameters of the sham stimulation (frequency, pulses, stimulation site and intensity) were the same as for active stimulation. The sham stimulation was defined with a coil diverted by90 degrees over the same area and same intensity and design as real repetitive transcranial magnetic stimulation. An also cognitive-behavioral therapy applied in this group. Percentage of people whose Panic Disorder Severity Scale score is above 4. Timepoint: Measurement of panic before intervention, in the tenth session of the intervention, after the intervention, follow-up for two months after the intervention. Method of measurement: Panic Disorder Severity Scale. Percentage of people whose Beck questionnaire score is above 20. Timepoint: Measurement of depression before the intervention, after intervention, tow-month follow-up intervention. Method of measurement: Beck Questionnaire. Percentage of people whose Hamilton questionnaire score is above 17. Timepoint: Measurement of depression before the intervention, after intervention and tow-month follow-up intervention. Method of measurement: Hamilton Depression Test. Cognitive test score in Stroop test. Timepoint: Measurement of attention bias before intervention, after intervention and tow-month follow-up after intervention. Method of measurement: Stroop test. Analyze the electroencephalography results. Timepoint: Measurements before the intervention, after the intervention. Method of measurement: Electroencephalography. The higher the score, the higher the emotion regulation. Timepoint: Measuring emotion regulation strategies before intervention, after intervention and follow-up for tow months after intervention. Method of measurement: Gross and John Emotion Regulation Questionnaire. Zanjan University of Medical Sciences Approved 2021-05-25 Ethics Committee of Zanjan University of Medical Sciences Azadegan Square Zanjan Zanjan Iran (Islamic Republic of)