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IRCT20200716048117N1 IRCT 2020-10-18 Tehran University of Medical Sciences The effect of transcranial direct current stimulation (tDCS) and omega-3 supplementation on depression and weight Determining the effectiveness of transcranial direct current stimulation (tDCS) and omega-3 supplementation on executive functions, food craving, and depressive symptoms in patients with depression and overweight 2019-12-06 anticipated 100 Complete https://irct.ir/trial/50663 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: Randomization method: block, randomization unit: individual, tools and randomization sequence: determined by Excel software. Allocation concealment is done by coding, Blinding description: In this double-blind study, participants, the principal investigator, the clinical caregiver, the evaluator, and the data analyst were all blind. Description of how to blind: Group 1: tDCS+ medicine Group 2: SHAM+ placebo Group 3: SHAM+ medicine Group 4: tDCS+ placebo Groups are hidden from the view of the research team and study participants by coding and placebo. 3 Condition 1: mild Depression. Condition 2: Moderate depression. Condition 3: Obesity. Intervention 1: Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, and omega-3 supplement (5 cc daily, containing 736 mg (EPA) And 460 mg (DHA)). Intervention 2: Intervention group 2: Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, And omega-3 placebo supplement (5 cc daily, soybean oil). Intervention 3: Third Intervention group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and omega-3 supplement (5 cc daily, containing 736 mg of eicosapentaenoic acid (EPA) and 460 mg docosahexaenoic acid (DHA)).0 mg DHA). Intervention 4: Control group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and the placebo of omega-3 (5 cc daily, soybean oil). Yes - There is a plan to make this available What will be shared: All data is potentially shareable after deleting individual IDs. When: Access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The analyzes used in the article are allowed on the delivered data. Where to obtain: Requests for data / documentation should only be sent via email to the developer. Responsible person: Dr. Seyed Ali Mostafavi E-Mail: Mostafavi_a@sina.tums.ac.ir How to obtain: After sending an e-mail to the given documents or files, this information may be sent to the applicant's e-mail as soon as possible. Comments:
public Mahla Tabasi
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
Tehran Iran (Islamic Republic of) 1333795914 +98 21 5541 3540 mahla.tabasi93@gmail.com Tehran University of Medical Sciences scientific Seyed Ali Mostafavi
Roozbeh Hospital, Psychiatric and Psychological Research Center, South Kargar St., Tehran., Iran.
Tehran Iran (Islamic Republic of) 1333795914 +98 21 5541 3540 pprct@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Women with depression (Beck depression score above 14) overweight or obesity (BMI≥25) 18 to 60 years old 18 years 60 years Female Reluctance and satisfaction to participate in the study during pregnancy or lactation Other major psychiatric illnesses such as bipolar depression, Schizophrenia, neurological diseases such as epilepsy History of major head trauma and neurofeedback in the last two months F32.0 F32.1 E66.0 Major depressive disorder, single episode, mild Major depressive disorder, single episode, moderate Obesity due to excess calories Treatment - Other Treatment - Other Treatment - Other Other Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, and omega-3 supplement (5 cc daily, containing 736 mg (EPA) And 460 mg (DHA)). Intervention group 2: Intervention group 1: 3 sessions of transcranial direct current stimulation (tDCS), one session per week, 4 sessions of stimulation for 15 minutes each time, And omega-3 placebo supplement (5 cc daily, soybean oil). Third Intervention group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and omega-3 supplement (5 cc daily, containing 736 mg of eicosapentaenoic acid (EPA) and 460 mg docosahexaenoic acid (DHA)).0 mg DHA). Control group: 3 sessions of Sham transcranial direct current stimulation (tDCS) of the brain, one session per week, each session consists of 4 episodes of stimulation, each lasting 15 minutes, and the placebo of omega-3 (5 cc daily, soybean oil). Depression score 14 and above in Beck questionnaire. Timepoint: Measurement of depression at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake. Method of measurement: Beck Depression Inventory. Scores of executive functions of individuals in Simple Strop computer software and Wisconsin card computer test. Timepoint: Measurement of executive functions at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake. Method of measurement: Simple Strop computer software and Wisconsin card computer test. Individual cravings score in the Summary Food Trait Questionnaire (FCQ-T). Timepoint: Measurement of food craving at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake. Method of measurement: Summary Food Trait Questionnaire (FCQ-T). People weigh in kilograms and their fat percentage with a pneumatic fat analyzer _ Model BF 511. Timepoint: Measurement of weight and fat percentage at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake. Method of measurement: People weigh in kilograms and their fat percentage with a pneumatic fat analyzer _ Model BF 511. Appetite score in a simple appetite questionnaire SNAQ. Timepoint: Measurement of appetite at the beginning of the study (before the intervention), and 14 and 28 days after receiving brain stimulation and omega-3 intake. Method of measurement: Simple appetite questionnaire SNAQ. Tehran University of Medical Sciences Approved 2019-09-24 Vice Chancellor for Research and Technology, Tehran University of Medical Sciences No. 1, Qods Ave., Keshavarz Blvd., Tehran., Iran. Tehran Tehran Iran (Islamic Republic of)