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IRCT20190812044515N1 IRCT 2023-08-28 Islamic Azad University Investigating the effect of Tdcs on metacognitive therapy in the treatment of major depressed people Psychotherapy plus: augmentation of metacognitive therapy with prefrontal transcranial direct current stimulation (tDCS) on depressive symptoms, rumination, and brain waves pattern based on quantitative analysis of the electroencephalogram (QEEG) in individuals with major depressive disorder- sham-controlled randomized double-blind study. 2022-11-22 anticipated 60 Complete https://irct.ir/trial/72021 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Blinding description: Randomization to two groups of active tDCS or sham is done in the second step through the random assignment of identifiers by an independent clinical physician who is not involved in the study. To reduce bias during data collection and assessment of clinical endpoints, double-blind tDCS treatment is used. All study personnel, metacognitive therapists, and patients will have no knowledge of whether the active state or sham state will be activated by the tDCS device. Patients are asked not to discuss stimulation with other members of the group. N/A depression. Intervention 1: The first intervention group: metacognitive therapy + Active-tDCS, in the above intervention, after the session entered the main part, i.e. the challenge with beliefs, real tDCS with a current whose anode electrode in the posterior-lateral prefrontal cortex of the left DLPC is equivalent to the F3 point in the -20 system. 10EEG and the cathode electrode is on the top of the cingulate cortex on the opposite side, it is activated. And the brand used is ActivaDosII. Intervention 2: Intervention group: second intervention group: metacognition therapy + sham-tDCS, in the above intervention, after the session enters the main part, i.e. the challenge with beliefs, tDCS is inactive, in such a way that the location of the electrodes is the same as the anodic stimulation electrodes, with this difference For the initial itching sensation, the current was applied only in the first 30 seconds and then stopped during the test. And the brand used is ActivaDosII. Intervention 3: Intervention group: The third intervention group: metacognitive therapy, metacognitive therapy group based on the practical guide of metacognitive treatment of anxiety and depression was implemented for eight sessions of 90-120 minutes among the subjects of the experimental group. Intervention 4: Control group: They did not receive any intervention during the treatment period, but they were assured that after the end of the research period, therapeutic intervention will be used to help them. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: It will be available for researchers working in academic and scientific institutions Conditions: Keeping ethical issues in mind, all analyzes are unimpeded Where to obtain: To receive data, they can correspond with the following email: v_farahmand_psy@yahoo.com How to obtain: After sending the request to the mentioned email, according to the volume of the request, the request will be answered between 1 and 7 days Comments:
public Shahnaz Nouhi
University blvd
Shahrood Iran (Islamic Republic of) 36199-43189 0092332394530 psynut.sh@gmail.com Islamic Azad University scientific Shahnaz Nouhi
University blvd
shahrood Iran (Islamic Republic of) 36199-43189 +98 23 3239 4530 psynut.sh@gmail.com Islamic Azad University Iran (Islamic Republic of) Not having a history of participating in a metacognitive psychotherapy program. Not having a history of epilepsy or convulsions. Not having a history of shock therapy (ECT). Having a score above 20 in the Beck depression questionnaire. Not having acute suicidality to participate in treatment sessions. Positive safety screening to perform tDCS. 20 years 60 years Both Substance abuse or dependence in the last 6 months (excluding nicotine, with current or past nicotine use) Psychotic disorders (lifelong) including schizoaffective disorders or depressive episodes with psychotic symptoms (lifelong) Bipolar disorders (types I and II) Neurological disorders, such as stroke in the last 2 years, epileptic attacks (for life), epilepsy, dementia, Parkinson's, Huntington's, multiple sclerosis, as well as any other neurological disease that leads to increased intracranial pressure or increased risk of epileptic seizures Not having a current risk of suicide, based on the researcher's personal assessment F32 Major depressive disorder, single episode Treatment - Devices Treatment - Devices Treatment - Other Other The first intervention group: metacognitive therapy + Active-tDCS, in the above intervention, after the session entered the main part, i.e. the challenge with beliefs, real tDCS with a current whose anode electrode in the posterior-lateral prefrontal cortex of the left DLPC is equivalent to the F3 point in the -20 system. 10EEG and the cathode electrode is on the top of the cingulate cortex on the opposite side, it is activated. And the brand used is ActivaDosII. Intervention group: second intervention group: metacognition therapy + sham-tDCS, in the above intervention, after the session enters the main part, i.e. the challenge with beliefs, tDCS is inactive, in such a way that the location of the electrodes is the same as the anodic stimulation electrodes, with this difference For the initial itching sensation, the current was applied only in the first 30 seconds and then stopped during the test. And the brand used is ActivaDosII. Intervention group: The third intervention group: metacognitive therapy, metacognitive therapy group based on the practical guide of metacognitive treatment of anxiety and depression was implemented for eight sessions of 90-120 minutes among the subjects of the experimental group. Control group: They did not receive any intervention during the treatment period, but they were assured that after the end of the research period, therapeutic intervention will be used to help them. Depression score. Timepoint: Measurement of depression at the beginning of the study and 10 sessions after the intervention and 30 days after the last visit session. Method of measurement: Beck Depression Questionnaire and Nelen Hoeksma Rumination Questionnaire. Rumination. Timepoint: At the beginning of the study and the last visit and 30 days after the last visit. Method of measurement: Nelen Hoeksma Rumination Questionnaire. Islamic Azad University Approved 2023-08-12 Islamic Azad University - Shahrood branch University blvd Shahrood Semnan Iran (Islamic Republic of)