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IRCT20200915048729N1 IRCT 2020-09-27 Arak University of Medical Sciences Impact of Cognitive Behavioral Therapy (CBT) on hemodialysis patients The effect of Cognitive Behavioral Therapy (CBT) on mental health and happiness in hemodialysis patients. 2020-10-01 anticipated 40 Complete https://irct.ir/trial/50988 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The subjects will be randomly divided into two groups of intervention and control group, each group will be 20 patiennts. The subjects were randomly divided into two groups of intervention and control. Letter A is assigned to the samples of intervention group and letter B to the samples of the control group, In this method, six modes of AABB, BBAA, BABA, ABBA, BAAB and ABAB are written in separate worksheets and placed inside a container. Then go to Randomly take one of the sheets out of the container, assuming ABAB. We put the first patients in Group A, the second in Group B, the third in Group A, and the fourth in Group B, and this leaf. And that's why, based on these six modes, 24 patients are selected and entered into groups. We repeat this method until 40 patients are selected. Since the sample size in this study is 40 patients, this operation is repeated twice. N/A Coronic Kidny Diseass. Intervention 1: Intervention group: This study is an interventional clinical trial with the intervention and control groups that will be done by random sampling on 40 patients referred to Farabi Bastak Hospital Hemodialysis Center. Patients will be entered into the study after completing the consent form. Patients will be randomly divided into two groups of intervention and control group. 20 patients will be placed in each group. At first, patients will complete the Oxford Mental Health and Happiness Questionnaire before they begin their interventions. Then, cognitive Behavioral Therapy interventions will be taught to the intervention group in 8 weekly sessions and 90 minutes per session according to the protocols of this treatment by the trained person. Sessions are briefly included: valuable progressive muscle relaxation, familiarity with stress and stressors, familiarity with self-control strategies, substitution of negative thoughts with positive thoughts, familiarity with different types of cognitive errors (thinking mistakes), familiarity with a variety of assertive behaviors, familiarity with strategies to increase self-esteem, and familiarity with skills strategies. After all the sessions, both questionnaires will be completed by the patients again. Data will be analyzed using spss software. The data will be analyzed using spss software. Intervention 2: Control group: he control group in the study will be a group with 20 patients after random selection. At first, both keyes mental health questionnaire and Oxford happiness questionnaire will be completed by the members of the group. During the study period, no training or intervention will be done on this group and will receive routine services of hemodialysis center. After 8 weeks, they will again complete the mental health and happiness questionnaires. The results obtained by this group will be analyzed using spss software, and according to the objectives of the study, it will be discussed and concluded. Yes - There is a plan to make this available What will be shared: After the end of the study the data files and individual data files including age , sex , duration of hemodialysis and … ) patients can be shared after non recognizable. When: After the end of the study , the release of documents / data files The release of the data file (access to information mental health questionnaire and happiness questionnaire) is published six months after the publication of the published results. To whom: After the end of the study , the documentation is permitted for all those interested in the study. Conditions: After the end of the study, the use of data or study documents to use in other studies is provided as the source of the study. Where to obtain: in order to obtain the documentation,Faeqheh Paravar, with the postal address of province Hormozgan, Bastak City, Enghelab street Send mail to paravar.faeq @ gmail. com send Watsapp No. 09184872690 to Faeqheh paravar How to obtain: people interested in receiving study documentation, can send their request to me The request will usually be answered in the shortest possible time, usually 2 hours. paravar.faeqheh@gmail.com The text of the request will be sent to whatsapp number 09184872690. Comments:
public Faeqheh Paravar
Enghelab
Bastak Iran (Islamic Republic of) 7961613153 +98 76 4432 2693 paravar.faeqheh@gmail.com Arak University of Medical Sciences scientific Faeqheh Paravar
Enghelab
Bastak Iran (Islamic Republic of) 7961613153 +98 76 4432 2693 paravar.faeqheh@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) At least 3 months have passed since the onset of hemodialysis. No use of psychological drugs by patients. Patients undergo hemodialysis for 2 or 3 weekly sessions and each session for 4 hours. 18 years 65 years Both Patients have a history of hospitalization due to psychological problems. I12.0 Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease Behavior Behavior Intervention group: This study is an interventional clinical trial with the intervention and control groups that will be done by random sampling on 40 patients referred to Farabi Bastak Hospital Hemodialysis Center. Patients will be entered into the study after completing the consent form. Patients will be randomly divided into two groups of intervention and control group. 20 patients will be placed in each group. At first, patients will complete the Oxford Mental Health and Happiness Questionnaire before they begin their interventions. Then, cognitive Behavioral Therapy interventions will be taught to the intervention group in 8 weekly sessions and 90 minutes per session according to the protocols of this treatment by the trained person. Sessions are briefly included: valuable progressive muscle relaxation, familiarity with stress and stressors, familiarity with self-control strategies, substitution of negative thoughts with positive thoughts, familiarity with different types of cognitive errors (thinking mistakes), familiarity with a variety of assertive behaviors, familiarity with strategies to increase self-esteem, and familiarity with skills strategies. After all the sessions, both questionnaires will be completed by the patients again. Data will be analyzed using spss software. The data will be analyzed using spss software. Control group: he control group in the study will be a group with 20 patients after random selection. At first, both keyes mental health questionnaire and Oxford happiness questionnaire will be completed by the members of the group. During the study period, no training or intervention will be done on this group and will receive routine services of hemodialysis center. After 8 weeks, they will again complete the mental health and happiness questionnaires. The results obtained by this group will be analyzed using spss software, and according to the objectives of the study, it will be discussed and concluded. Mental health score in Keyes ' mental health questionnaire. Timepoint: Measuring mental health questionnaire before intervention in the intervention group,then 8 weekly sessions of cognitive behavioral therapy training، and re-measurement of mental health questionnaire in the intervention group. Method of measurement: Keys Mental Health Questionnaire. Happiness Score in Oxford Happiness Questionnaire. Timepoint: Measuring Oxford Happiness Questionnaire before intervention inintervention group،then 8 weekly sessions of cognitive behavioral therapy training, and again, the questionnaire of happiness in the intervention group. Method of measurement: Oxford Happiness Questionnaire. Arak University of Medical Sciences Approved 2020-05-06 Ethics committee of Arak University of Medical Sciences Enghelab Bastak Hormozgan Iran (Islamic Republic of)