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IRCT20240107060643N1 IRCT 2025-01-03 Islamic Azad University Investigating the synergy of three cognitive behavioral therapy methods, repeated transcranial magnetic stimulation, and transcranial direct current stimulation on major depression patients Comparison of synergestic effectiveness between cognitive behavioral therapy (CBT) and repeated transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS) in cognitive flexibility, attention control, working memory and reducing signs and symptoms of MDD patients 2021-09-23 anticipated 65 Complete https://irct.ir/trial/74984 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples are entered into four groups using simple randomization. Random assignment is done using Excel software. To do this, we enter sixteen numbers 1, sixteen numbers 2, sixteen numbers 3, and sixteen numbers 4 in the first column, which represent the three intervention groups and one control group, respectively. Then, we generate sixty-four random numbers in the second column using the (RAND) function. We sort the data (ascending or descending) based on the values ​​of the column containing the random numbers, Blinding description: The evaluator and data analyst are unaware of the type of intervention performed in the group. N/A Major depression. Intervention 1: Intervention group: Cognitive behavioral therapy is performed in 12-16 sessions (45-60 minutes) according to the protocol (Leahy, 2012) twice a week. After the initial assessment and identification of the patient's problems, familiarization with the treatment begins. After that, intervention and training in cognitive and behavioral techniques are provided. Intervention 2: Intervention group: Each individual received repetitive transcranial magnetic stimulation (rTMS) at a frequency of 1 Hz, 20 minutes per session, 1200 pulses on the right dorsolateral prefrontal cortex (rDLPFC) and 10 Hz on the left dorsolateral prefrontal cortex (lDLPFC) for 20 minutes, 1600 pulses in total, 2800 pulses per session. Intervention 3: Control group: Control group: The group that receives one of the SSRI drugs at an antidepressant dose. Intervention 4: Intervention group: Combination of tDCS and drug therapy: The tDCS treatment program was implemented for the experimental group for 10 20-minute sessions (F3) and (F4). In direct current cranial wall stimulation treatment, two electrodes, one positive and the other negative, are placed on the head through a sponge pad soaked in a conductive solution. After passing through different areas (scalp, skull, etc.), the electric current through these electrodes reaches the surface of the cerebral cortex. The current that reaches this area charges the neurons and creates positive and negative poles, which leads to a change in the activity of that area. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Alireza Atabakhsh
Islamic Azad University, Zanjan branch - Pain Kouh Blvd. - Daneshjo Blvd
Zanjan Iran (Islamic Republic of) 58145-45156 +98 24 3346 9500 alirezaatabakhsh12@gmail.com Islamic Azad University scientific Mohsen Dadashi
Islamic Azad University, Zanjan branch - Pain Kouh Blvd. - Daneshjo Blvd
zanjan Iran (Islamic Republic of) 4513956184 024330180 mohsendadashi@zums.ac.ir Zanjan University of Medical Sciences Iran (Islamic Republic of) All major depression patients Subjects had to show symptoms of major depressive disorder confirmed by a psychiatrist according to the HDRS (21). The participants had to complete a written consent form and were not exposed to any psychological or complementary treatment for at least one month before entering the study. Carrying metal or other electrical devices on the head or having wounds and scratches on the scalp. Absent contraindications to tDCS, such as metal in the head or medical devices implanted in the brain, experience at least Three AHs per week Age: 18 to 65 years old 18 years no limit Both Risk of suicide, History of epilepsy and seizures Presence of an electrical or metal object in the body Presence of any neurological disease that affects the central nervous system (such as Parkinson's) Pregnancy Co-occurring bipolar disorder Psychosis F33.2 Major depressive disorder, recurrent severe without psychotic features Treatment - Other Treatment - Devices Treatment - Drugs Treatment - Devices Intervention group: Cognitive behavioral therapy is performed in 12-16 sessions (45-60 minutes) according to the protocol (Leahy, 2012) twice a week. After the initial assessment and identification of the patient's problems, familiarization with the treatment begins. After that, intervention and training in cognitive and behavioral techniques are provided. Intervention group: Each individual received repetitive transcranial magnetic stimulation (rTMS) at a frequency of 1 Hz, 20 minutes per session, 1200 pulses on the right dorsolateral prefrontal cortex (rDLPFC) and 10 Hz on the left dorsolateral prefrontal cortex (lDLPFC) for 20 minutes, 1600 pulses in total, 2800 pulses per session. Control group: Control group: The group that receives one of the SSRI drugs at an antidepressant dose. Intervention group: Combination of tDCS and drug therapy: The tDCS treatment program was implemented for the experimental group for 10 20-minute sessions (F3) and (F4). In direct current cranial wall stimulation treatment, two electrodes, one positive and the other negative, are placed on the head through a sponge pad soaked in a conductive solution. After passing through different areas (scalp, skull, etc.), the electric current through these electrodes reaches the surface of the cerebral cortex. The current that reaches this area charges the neurons and creates positive and negative poles, which leads to a change in the activity of that area. The individual's score on Hamilton Depression Rating Scale (HDRS). Timepoint: Measuring the severity of depressive symptoms before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: Hamiltonian measurement test. Wisconsin Cognitive Flexibility Test (WCST) score. Timepoint: Measuring the individual's WCST score before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: Wisconsin Cognitive Task (WCST) by Sina Software. Working memory score in the N-BACK test. Timepoint: Measuring the individual's N-BACK score before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: N-BACK working memory cognitive task by Sina Software. Cognitive selective attention score in the simple Stroop test. Timepoint: Measuring the individual's score on the simple stroop task before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: Simple Stroop cognitive attention and concentration task by Sina Company software. Cognitive attention inhibition score in the GONOGO test. Timepoint: Measuring the individual's score on the GONOGO task before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: Cognitive task of attention inhibition by Sina Company software. The individual's score on the beck Depression Inventory(BDI). Timepoint: Measuring the severity of depressive symptoms before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: he individual's score on Beck Depression Inventory (BDI). The individual's score on the Montgomery-Aasberg Depression Rating Scale (MADRS). Timepoint: Measuring the severity of depressive symptoms before the intervention, immediately after the intervention, and one month after the intervention as a follow-up. Method of measurement: Montgomery-Asberg Depression Scale (MADRS). Islamic Azad University Approved 2024-03-20 Islamic Azad University - Zanjan Branch (Research Ethics Committee) Islamic Azad University, Zanjan Branch - Arazi Payin Kooh Road - Daneshjoo Blvd. Zanjan Zanjan Iran (Islamic Republic of)