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IRCT20211031052929N1 IRCT 2022-01-10 Islamic Azad University of Shiraz Branch The Effectiveness of Mindfulness Based Cognitive Therapy on the quality of life, depression and plasma level of cortisol in patients with breast cancer and depressed people The Effectiveness of Mindfulness Based Cognitive Therapy (MBCT) on the quality of life, depression and plasma level of cortisol in patients with breast cancer and depressed people 2021-01-11 anticipated 60 Complete https://irct.ir/trial/59718 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects were divided into experimental and control groups based on simple randomization through a table of random numbers in two separate groups of breast cancer patients and depressed individuals. To use the table of random numbers, first the framework of the statistical community of 30 people in both groups was identified and they were given a two-digit code, respectively. Then the same numbers of digits were selected in the row or column direction. This work continued until 30 items in each group were selected as a sample. N/A Condition 1: Breast Cancer. Condition 2: Depressed People. Intervention 1: intervention group: mindfulness-based cognitive therapy : 1- Introduction of the program, structure and goals of the group including familiarity with cancer, depression, familiarity with mindfulness and expression of its logic and presentation of homework for the consolidation of educational materials 2- Education and practice of mindfulness or breathing awareness techniques to increase attention and concentration capacity include 45 minute meditation of body care, ten minutes of breathing along with mindfulness and expressing the logic of each of these techniques, thinking about exercises and accurate sensation of each of them and a three-minute breathing space and expressing its logic 3- Implementation of muscular relaxation technique, practicing conscious movement, keeping thoughts and minds widespread through pursuit of meditative exercises and focusing on conscious breathing and body organs, familiarity with mindfulness (the concept of automatic guide and mind states), familiarity with logic and the goals of this therapy and the practice of mindfulness technique, three-minute breathing 4- 45-minute training and practice, sitting meditation technique and expressing its logic, three-minute breathing exercise and providing simulated exercises for use in times of emotion, understanding negative spontaneous thoughts on depression and cancer, training how the table creates emotional thoughts and training ten-minute breathing along with mindfulness 5- 45-minute body check practicing, training and exercising of discovering reactions to common patterns and applying the potential talents of mindfulness skills to ease the reaction to the present time experiences (control of the wanderer mind), teaching and practicing meditation to accept and evaluate spontaneous thoughts and identification of common cognitive errors in depression 6-45-minute sitting meditation practicing, reviewing patients' problems during home exercise, emotions and anxieties during exercises, teaching techniques to respond to negative spontaneous thoughts, practicing three-minute body check technique and conscious breathing and making awareness the reactions against depression 7- Performing meditation exercises, practicing three-minute breathing, designing a problem during the exercise and discovering their effects on the body and mind, discussing how best continue to move and order created in the last few weeks, a list of pleasurable symptoms and skillfulness and exercising body check 8- Summation and reviewing the program, receiving feedback from group members, applying lessons for dealing with future creation, closing ceremonies, and post-test implementation. Intervention 2: Control group: patients in this group received no treatment. 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 I have not made a decision yet
public Zahra Olyaee
5 Km of Sadra City
Shiraz Iran (Islamic Republic of) ۷۴۷۳۱ - ۷۱۹۸۷ 07136410041-44 olyaiez@yahoo.com Islamic Azad University of Shiraz scientific Zahra Olyaee
5 km from Sadra City
Shiraz Iran (Islamic Republic of) ۷۴۷۳۱ - ۷۱۹۸۷ 07136410041-44 olyaiez@yahoo.com Islamic Azad University of Shiraz Iran (Islamic Republic of) Iran (Islamic Republic of) Satisfaction to participate in research the age range between 18 to 75 Major depressive disorder based on DSM - V Score between 20 to 28 in the second edition of the Beck Depression Scale At least fifth elementary degree Clinical diagnosis of stage 0 to 3 breast cancer based on clinical findings of cytology and physician diagnosis (in the group of people with cancer) 18 years 75 years Female Men with breast cancer(in the group of people with cancer) Metastasis to other organs of the body including liver, kidney and brain (in the group of people with cancer) Spectrum of schizophrenia and other psychotic disorders, bipolar and related disorders Substance Abuse Disorders Taking drugs that affect the psyche and antidepressants Common meditation or yoga exercises during the last three months before entering the study History of participating in a mindfulness program at the time of project implementation C50 F32.1 Malignant neoplasm of breast Major depressive disorder, single episode, moderate Behavior Behavior intervention group: mindfulness-based cognitive therapy : 1- Introduction of the program, structure and goals of the group including familiarity with cancer, depression, familiarity with mindfulness and expression of its logic and presentation of homework for the consolidation of educational materials 2- Education and practice of mindfulness or breathing awareness techniques to increase attention and concentration capacity include 45 minute meditation of body care, ten minutes of breathing along with mindfulness and expressing the logic of each of these techniques, thinking about exercises and accurate sensation of each of them and a three-minute breathing space and expressing its logic 3- Implementation of muscular relaxation technique, practicing conscious movement, keeping thoughts and minds widespread through pursuit of meditative exercises and focusing on conscious breathing and body organs, familiarity with mindfulness (the concept of automatic guide and mind states), familiarity with logic and the goals of this therapy and the practice of mindfulness technique, three-minute breathing 4- 45-minute training and practice, sitting meditation technique and expressing its logic, three-minute breathing exercise and providing simulated exercises for use in times of emotion, understanding negative spontaneous thoughts on depression and cancer, training how the table creates emotional thoughts and training ten-minute breathing along with mindfulness 5- 45-minute body check practicing, training and exercising of discovering reactions to common patterns and applying the potential talents of mindfulness skills to ease the reaction to the present time experiences (control of the wanderer mind), teaching and practicing meditation to accept and evaluate spontaneous thoughts and identification of common cognitive errors in depression 6-45-minute sitting meditation practicing, reviewing patients' problems during home exercise, emotions and anxieties during exercises, teaching techniques to respond to negative spontaneous thoughts, practicing three-minute body check technique and conscious breathing and making awareness the reactions against depression 7- Performing meditation exercises, practicing three-minute breathing, designing a problem during the exercise and discovering their effects on the body and mind, discussing how best continue to move and order created in the last few weeks, a list of pleasurable symptoms and skillfulness and exercising body check 8- Summation and reviewing the program, receiving feedback from group members, applying lessons for dealing with future creation, closing ceremonies, and post-test implementation Control group: patients in this group received no treatment. Depression score in Beck questionnaire (BDI-II). Timepoint: Before and after intervention. Method of measurement: Beck depression questionnaire (BDI-II). Quality of life score in the questionnaire SF36. Timepoint: Before and after intervention. Method of measurement: SF36 quality of life questionnaire. Serum cortisol levels. Timepoint: Before and after intervention. Method of measurement: Blood test. دانشگاه آزاد اسلامی واحد شیراز Approved 2020-09-26 Committee on Ethics in Mashhad University of Medical Sciences University of research and technology assistance, second floor , Qoreishi building, Daneshgah ST mashhad Razavi Khorasan Iran (Islamic Republic of)