The comparison of effectiveness of religious cognitive behavior therapy and classic cognitive behavior therapy and repetitive transcranial magnetic stimulation (rTMS) on anhedonia, rumination with their related neural circuits in patients with major depression

Comparison of the effectiveness of psychological treatment methods (classical and religious cognitive-behavioral therapy) and repetitive transcranial magnetic stimulation (rTMS) on anhedonia, rumination and neural networks associated with each of them

Clinical trials with control group with randomized double-blind parallel groups. Sixty MDD patients are enrolled in the study from December 2016 to May 2018.Random allocation software was used for random sequence generation. The random allocation process was carried out by a researcher blinded to the random sequence in order to avoid bias in this field. Sequentially numbered, sealed,opaque envelopes (SNOSE) technique was used to hide it.

The study is conducted at Atieh Clinical Neuroscience Center. Participants receive treatment for 10 sessions after being assigned to the intervention group. Before starting the treatment, the participants perform the Snaith-Hamilton Pleasure Scale (SHAPS) and the Hamilton Depression Rating Scale (HDRS) at baseline and during the tenth session for clinical evaluation. qEEG will be taken from the participants to check the anhedonia and ruminantion networks at baseline and treatment completion.

Inclusion criteria: Outpatients male and female with the range of 18-70 years of age, The diagnosis of Major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Having beck depression inventory (BDI)>14, Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks, Completion of consent form,Being under supervision of a psychiatrist. exclusion criteria:The history of rTMS treatment for any reason, having cardiac pacemaker,The risk of seizure with any reasons, pregnancy,High risk of suicide,Intracranial implant and other ferromagnetic materials close to the head

There are 4 intervention groups in this study. The first group received classical cognitive-behavioral therapy, the second group received religious cognitive-behavioral therapy; the third group received rTMS and the fourth group received sham rTMS. In the control group, the stimulation parameters are similar to the actual TMS group, except that the coil angel is 90 ° and perpendicular to the head.

Anhedonia; Rumination,

Random allocation software was used for random sequence generation. The random allocation process was carried out by a researcher blinded to the random sequence in order to avoid bias in this field. SNOSE technique was used to hide it.

In this study, participants and outcome evaluators are blinded to the study groups. The outcome evaluator performs the evaluation without knowing which intervention group the participant belongs to. According to the explanations stated in the informed consent, the participants are told that they are randomly assigned to the intervention groups and, if they are in the control group, after the completion of the test, they will undergo the same number of sessions considered for the other patients. In the control group, the participant will receive the sham TMS. That is, all the parameters are the same as the actual TMS group, except that coil angle is different. Therefore, the participants are blinded to the type of treatment they receive.

The information on the main outcome of the study can be shared.

Access time: one year after the release of the results

The researchers working in the academic institutions

The study data is available for writing meta-analysis.

To receive the data, the principal researcher of the project must be contacted via email Reza Kazemi email:rezakazemi@ut.ac.ir

After receiving the application for documentation, if the conditions are met, the documentation will be submitted to the applicant by the principal researcher within a week