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IRCT20210611051540N1 IRCT 2021-07-10 Islamic Azad University Effect of Neurofeedback for the treatment of Depression The Effectiveness of Neurofeedback on Working Memory, Cognitive Flexibility and Severity of Patients' Symptoms with Mild Depression 2021-07-14 anticipated 30 Complete https://irct.ir/trial/56819 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first, patients are selected according to the inclusion criteria. And then according to the random sequence obtained through Random allocation software In the same way, patients will be randomly divided into experimental and control groups. N/A بیماران مبتلا به افسردگی خفیف. Intervention 1: Intervention group: Patients with mild depression who receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to therapeutic intervention and data collection, neurofeedback device treatment protocols and tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. Each depressed patient undergoes neurotherapy for 30 minutes 2 times a week for 3 months in each session. All patients complete the questionnaire and only the intervention group is treated with neurofeedback. The effectiveness of neurofeedback depends on the specific area of ​​the brain depending on the type of disorder. In this form, the pattern of brain waves in the disorder is determined first, then the degree of deviation of the waves from the normal pattern is determined, which is done through quantitative electroencephalography.Quantitative electroencephalography is obtained from 19 cranial sites identified according to the 10-20 system, and in fact 19 electrodes are placed on the skull. In fact, we can say that neurofeedback technology response to psychotherapy, cognitive rehabilitation and poor cortical function It has been used successfully in the treatment of depression, anxiety, post-traumatic stress disorder, personality disorders, addiction, as well as obsessive-compulsive disorder. In this treatment, which is a self-regulatory skill, the brain works more efficiently with the awareness of the person with the disorder through auditory or graphic signals.Based on what has been said in this study, the question is whether neurofeedback has an effect on working memory, cognitive flexibility and the severity of symptoms of patients with mild depression referred to Ava Psychiatric Clinic in Rasht? Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations.This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence.In which part of the test is the two-sentence section to the seven-sentence section read to the subjects, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active. Intervention 2: Control group: Patients with mild depression who do not receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to data collection, tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. All patients complete the questionnaire and only the intervention group will be treated with neurofeedback. The control group will complete the questionnaire twice.Once before the start of treatment in the experimental group and once after the end of treatment in the experimental group. Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations. This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence. Each section of the test is read to the subjects in a two-sentence section to a seven-sentence section, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active. Yes - There is a plan to make this available What will be shared: All data obtained from the results of questionnaires, diagnostic interviews and improving the performance of clients will be published. When: Access period starts from September 2021 To whom: Data and other documents are available to all researchers in the field of research Conditions: If other people request to receive data and documents, send a message to my personal email. Where to obtain: Applicants should refer to Avae Salamat Clinic located in Rasht, Enghelab Street, next to Zohralabi Pharmacy, to receive the required documents or data. Maryam Samadi Tahergorabi is responsible by calling 09380115195 and emailing maryam.samadi995@gmail.com. How to obtain: Applicants should call 09380115195 to receive the required documents or data or send an email to maryam.samadi995@gmail.com. Documents will be provided to them within 72 hours to a week. Comments:
public Maryam Samadi Tahergoorabi
unit9, Mahan building, Amoozegar alley, Hafez street
Rasht Iran (Islamic Republic of) 4144794157 +98 13 3334 2933 maryam.samadi995@gmail.com Islamic Azad University scientific Maryam Samadi Tahergoorabi
unit9, Mahan building, Amoozegar Alley, Hafez street
Rasht Iran (Islamic Republic of) 4144794157 001333342933 maryam.samadi995@gmail.com Islamic Azad University Iran (Islamic Republic of) The age of the person is between 20 to 40 years A diagnostic interview has been conducted with the person The person has referred to Avae Salamat Clinic as a patient 20 years 40 years Both If under other medical conditions If the patient has severe depressive disorder If the patient has a disorder other than depression Treatment - Devices Treatment - Devices Intervention group: Patients with mild depression who receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to therapeutic intervention and data collection, neurofeedback device treatment protocols and tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. Each depressed patient undergoes neurotherapy for 30 minutes 2 times a week for 3 months in each session. All patients complete the questionnaire and only the intervention group is treated with neurofeedback. The effectiveness of neurofeedback depends on the specific area of ​​the brain depending on the type of disorder. In this form, the pattern of brain waves in the disorder is determined first, then the degree of deviation of the waves from the normal pattern is determined, which is done through quantitative electroencephalography.Quantitative electroencephalography is obtained from 19 cranial sites identified according to the 10-20 system, and in fact 19 electrodes are placed on the skull. In fact, we can say that neurofeedback technology response to psychotherapy, cognitive rehabilitation and poor cortical function It has been used successfully in the treatment of depression, anxiety, post-traumatic stress disorder, personality disorders, addiction, as well as obsessive-compulsive disorder. In this treatment, which is a self-regulatory skill, the brain works more efficiently with the awareness of the person with the disorder through auditory or graphic signals.Based on what has been said in this study, the question is whether neurofeedback has an effect on working memory, cognitive flexibility and the severity of symptoms of patients with mild depression referred to Ava Psychiatric Clinic in Rasht? Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations.This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence.In which part of the test is the two-sentence section to the seven-sentence section read to the subjects, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active. Control group: Patients with mild depression who do not receive neurofeedback treatment. The statistical population of this study will consist of all patients with mild depression who refer to Avaye Salamat psychological clinic during the first quarter of 1400. According to forecasts, the number of these people will be 80. A total of 30 patients will be selected by availability and randomly assigned to two groups (15 in the experimental group and 15 in the control group).In relation to data collection, tools such as Beck Depression Inventory, Cognitive Flexibility Questionnaire and Active Memory Questionnaire will be used. All patients complete the questionnaire and only the intervention group will be treated with neurofeedback. The control group will complete the questionnaire twice.Once before the start of treatment in the experimental group and once after the end of treatment in the experimental group. Depression Inventory: This questionnaire was developed by Goldberg (1979) and has 18 items in a 5-point Likert scale; Very high (5), high (4), medium (3), low (2), very low (1) and not at all (0) are scored. The minimum and maximum scores of this questionnaire are 18 and 108, respectively, and its cut-off point is 54. Cognitive Flexibility Questionnaire: This questionnaire was developed by Dennis and Vanderwall (2010) and consists of 20 questions in a 7-point range; I strongly agree to strongly disagree. The questionnaire has three sub-components including; 1) the desire to understand difficult situations as controllable situations, 2) the ability to understand several alternative justifications for human life events and behavior, and 3) the ability to create multiple alternative solutions to difficult situations. This questionnaire has a minimum score of 20, a maximum score of 140 and a cut-off point of 80. Active Memory Questionnaire: This questionnaire was developed by Danman and Carpenter (1980) and consists of 27 sentences. These sentences are divided into six parts: two-sentence, three-sentence, four-sentence, five-sentence, six-sentence and seven-sentence. Each section of the test is read to the subjects in a two-sentence section to a seven-sentence section, respectively, and they are asked to listen to these sections, each of which contains relatively difficult and unrelated sentences, and then two Do the following: 1- Recognize whether the sentence is semantically correct or not. 2. Write down the last word of each sentence. To score an active memory test, divide the number of correct answers in each section by the total number of sentences, and then add the number obtained from each section and divide it by two, the number obtained indicates the amount of memory capacity. Each subject will be active. Active Memory Score in the Active Memory Capacity Test by Daneman. Timepoint: Measurement of working memory at the beginning of the study and 10 sessions after starting neurotherapy. Method of measurement: Daneman Active Memory Capacity Test. Cognitive flexibility score in Dena and Vanderwall cognitive questionnaire. Timepoint: Measurement of flexibility at the beginning of the study and 10 sessions after starting neurotherapy. Method of measurement: Cognitive Flexibility Questionnaire Dena and Vanderwall. Depression score in Beck questionnaire. Timepoint: Measurement of the severity of depression at the beginning of the study and 10 sessions after starting neurotherapy. Method of measurement: Beck Depression Inventory. Lahijan Branch of Azad University Approved 2021-06-07 Ethics Committee of Lahijan Branch of Azad University Unit9, Mahan building, Amoozgr alley, Hafez street Rasht Guilan Iran (Islamic Republic of)