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IRCT20180503039509N1 IRCT 2018-10-30 Islamic Azad University of Qom The comparision between the effectiveness of mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) on anxiety, depression and fatigue in cancer patients. شناخت درمانی مبتنی بر ذهن آگاهی (MBCT) - درمان شناختی رفتاری (CBT) The comparision between the effectiveness of mindfulness-based cognitive therapy (MBCT) and cognitive behavioral therapy (CBT) on anxiety, depression and fatigue in cancer patients. 2018-11-01 anticipated 60 Complete https://irct.ir/trial/32687 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be performed through a table of random figures and allocation concealment will be performed by sealed envelopes which will be kept by the hospital reception. Based on these the participants will be assigned to CBT, MBCT and the control group, Blinding description: In this study the participant, the evaluator of the outcome and analyzer of data will not be aware how the individuals are allocated to mbct and cbt groups and control group. N/A Condition 1: colon, rectosigmoid and rectum cancer. Condition 2: breast cancer. Condition 3: Lymphatic cancer. Intervention 1: intervention group one: mindfulness-based cognitive therapy group Content of interventional sessions of mindfulness-based cognitive therapy1- Introduction of the program, structure and goals of the group, familiarity with cancer and anxiety, depression, and fatigue of patients having this disease, familiarity with mindfulness and expression of its logic and presentation of homework for the consolidation of educational materials2- 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 logic3- 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 (communication with the world in a different way) and the practice of mindfulness technique, three-minute breathing4- 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, recognizing Beck's cognitive model on anxiety and depression based on ABC and understanding negative spontaneous thoughts on cancer, training how the table creates emotional thoughts and training ten-minute breathing along with mindfulness5- 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 cancer6-45-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 anxiety, depression and fatigue7- 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 check8- 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: Intervention group two: Cognitive behavioral therapy group First sessionFamiliarization, introduction of rules and treatment process, acquaintance of the patient with the nature of their illness and the role of psychological factors in the emergence and exacerbation of symptoms and the introduction of cognitive behavioral therapy method and education of the relaxation technique (relaxation training is performed in all treatment sessions)The second session and the third sessionEducation of cognitive pattern for patients, introducing spontaneous thoughts, providing sheets to record invalid thoughts, identifying emerging thoughts of illnesses and unpleasant senses, investigating possible problems in recording thoughts and identifying emotions and helping them solveFourth and fifth sessionsMeet the challenge of irrational thoughts and beliefs, introducing challenges as a way to fight the irrational thoughts and beliefs that the patient wrote over the course of the week, delivering profits and losses, and Socratic questioning of thoughts that created unpleasant emotions.Sixth and seventh sessionsProblem-solving training, self-expression training, and education of planning for activities, and discussing problem solving methods as a way to cope with worries, training three passive, daring and aggressive behavioral styles in communication situations to strengthen self-expression and teaching time setting and planning for doing activitiesEighth sessionSummarizing and summation the contents of the past session, introducing several books in order to become more familiar with cognitive therapy, make the patient to pay attention to the intermediate beliefs and underlying assumptions, taking feedback from the patient towards treatment sessions. Intervention 3: Control group third group : The group didnot receive any 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 No more information
public Masoumeh Sheikhzadeh
No4. Meraj33 Alley. Ayatollah Saeidi ST
Kashan Iran (Islamic Republic of) 8716838371 +98 31 5522 4569 Sheikhzadehpsychology@gmail.com Mashhad University of Medical Sciences scientific Masoumeh Sheikhzadeh
No4. Meraj33 Alley. Ayatollah Saeidi ST
Kashan Iran (Islamic Republic of) 8716838371 +98 31 5522 4569 Sheikhzadehpsychology@gmail.com Islamic Azad University of Qom Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 and 50 years Minimum Cycle Degree (Given the active nature of the species and the contribution of the therapist and doing the homework to a degree, the energy and superhuman motivation of the ability to identify thoughts and emotions is needed).Ability to attend meetings Ability and informed consent of the company in the scheme Minimum duration of cancer for 6 months Not receiving psychological help at diagnosis 18 years 50 years Both No history of mental illness specifically Lack of physical illness other than the study C19 C50.4 C96.9 Malignant neoplasm of rectosigmoid junction Malignant neoplasm of upper-outer quadrant of breast Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified Behavior Behavior Behavior intervention group one: mindfulness-based cognitive therapy group Content of interventional sessions of mindfulness-based cognitive therapy1- Introduction of the program, structure and goals of the group, familiarity with cancer and anxiety, depression, and fatigue of patients having this disease, familiarity with mindfulness and expression of its logic and presentation of homework for the consolidation of educational materials2- 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 logic3- 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 (communication with the world in a different way) and the practice of mindfulness technique, three-minute breathing4- 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, recognizing Beck's cognitive model on anxiety and depression based on ABC and understanding negative spontaneous thoughts on cancer, training how the table creates emotional thoughts and training ten-minute breathing along with mindfulness5- 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 cancer6-45-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 anxiety, depression and fatigue7- 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 check8- Summation and reviewing the program, receiving feedback from group members, applying lessons for dealing with future creation, closing ceremonies, and post-test implementation. Intervention group two: Cognitive behavioral therapy group First sessionFamiliarization, introduction of rules and treatment process, acquaintance of the patient with the nature of their illness and the role of psychological factors in the emergence and exacerbation of symptoms and the introduction of cognitive behavioral therapy method and education of the relaxation technique (relaxation training is performed in all treatment sessions)The second session and the third sessionEducation of cognitive pattern for patients, introducing spontaneous thoughts, providing sheets to record invalid thoughts, identifying emerging thoughts of illnesses and unpleasant senses, investigating possible problems in recording thoughts and identifying emotions and helping them solveFourth and fifth sessionsMeet the challenge of irrational thoughts and beliefs, introducing challenges as a way to fight the irrational thoughts and beliefs that the patient wrote over the course of the week, delivering profits and losses, and Socratic questioning of thoughts that created unpleasant emotions.Sixth and seventh sessionsProblem-solving training, self-expression training, and education of planning for activities, and discussing problem solving methods as a way to cope with worries, training three passive, daring and aggressive behavioral styles in communication situations to strengthen self-expression and teaching time setting and planning for doing activitiesEighth sessionSummarizing and summation the contents of the past session, introducing several books in order to become more familiar with cognitive therapy, make the patient to pay attention to the intermediate beliefs and underlying assumptions, taking feedback from the patient towards treatment sessions. Control group third group : The group didnot receive any treatment. Anxiety - depression. Timepoint: Before and immediately after the intervention. Method of measurement: Using Beck Anxiety and Depression Inventory. Fatigue. Timepoint: before and after intervention. Method of measurement: Ocuyama Cancer Fatigue Questionnaire (2000). Islamic Azad University of Qom Approved 2018-04-21 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)