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IRCT20211214053413N1 IRCT 2022-06-24 University of Tehran Comparison of the effectiveness of cognitive-behavioral stress management technique (CBSMT) and self-care education and their combination in patients with type 2 diabetes Comparison of the effectiveness of cognitive-behavioral stress management technique (CBSMT) and self-care education and their combination on treatment adherence, diabetic self-care, health status, perceived stress, lifestyle and quality of life in patients with type 2 diabetes 2022-02-08 anticipated 60 Complete https://irct.ir/trial/60830 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research, randomization will be block, and the randomization unit will be cluster. Random assignment of patients (60 tons) to 4 groups (first 15 patients for group A, then 15 patients for group B, then 15 patients for group C and finally 15 patients for group D), using The order of generating integer random numbers (= INT (RAND (* * 60)) is performed by the rand function of Excel software. And D, will be done so that the names of the groups (intervention group 1; stress management based on cognitive-behavioral therapy, intervention group 2; self-care training, intervention group 3; stress management based on cognitive-behavioral therapy + self-care training, group Control; group 4) is written on four pieces of paper and will be folded, then by random selection of the first paper from four papers, type of intervention group A, by choosing the second paper from the remaining three papers, type of intervention group B, by selecting the third paper From the remaining two papers, the type of intervention in group C will be determined, and the remaining paper (fourth) will determine the type of intervention for group D. N/A Patients with type II diabetes. Intervention 1: Intervention group 1: Medication (Use of metformin according to the instructions of an endocrinologist) and 8 sessions of cognitive-behavioral stress management therapy (CBSMT) for 2 to 2.5 hours and once a week. Intervention 2: Intervention group 2: receive medication(Use of metformin according to the instructions of an endocrinologist) and 8 sessions of self-care training for 2 to 2.5 hours and once a week. Intervention 3: Intervention group 3: Medication(Use of metformin according to the instructions of an endocrinologist) and 8 sessions of combination of two treatments for 2 to 2.5 hours and once a week. Intervention 4: Control group: They only receive drug treatment(Use of metformin according to the instructions of an endocrinologist). Yes - There is a plan to make this available What will be shared: All related data to participants are shared after hiding patient's name. When: The period of access to the present research data will be available 6 months after publication of the research results in the form of research articles. To whom: The present study data will be available only to researchers working in the academic and scientific institutions. Conditions: The output of statistical analysis will be available Where to obtain: Applicants can apply for documentation and data via email at jalaliamineh95@gmail.com How to obtain: After completion of the research and publication of the extracted articles, it will be available for a maximum 6 months later. Comments:
public Amineh.Jalali
Tehran - Enghelab Square - Enghelab St. - 16 Azar St. - Central Organization of the University of Tehran
Tehran Iran (Islamic Republic of) 1358879331 +98 34 4326 3329 amineh.jalali@ut.ac.ir University of Tehran scientific Amineh Jalali
Kerman. Houshang Moradi St. Kermani, Houshang Moradi 9 alley, Nikan building, second floor, unit 3
Tehran Iran (Islamic Republic of) 1358879331 +98 34 4326 3329 amineh.jalali@ut.ac.ir University of Tehran Iran (Islamic Republic of) Age range 40-50 years Having diabetes type 2 for at least six months with a specialist physician diagnosis Higher education than the cycle Not using other treatment psychotherapy programs and changing medications during the research 40 years 50 years Both Have other types of diabetes Have severe diabetic complications that prevent research Acute or chronic medical illness that may cause problems with blood sampling E08 Diabetes mellitus due to underlying condition Diagnosis Diagnosis Diagnosis Diagnosis Intervention group 1: Medication (Use of metformin according to the instructions of an endocrinologist) and 8 sessions of cognitive-behavioral stress management therapy (CBSMT) for 2 to 2.5 hours and once a week. Intervention group 2: receive medication(Use of metformin according to the instructions of an endocrinologist) and 8 sessions of self-care training for 2 to 2.5 hours and once a week. Intervention group 3: Medication(Use of metformin according to the instructions of an endocrinologist) and 8 sessions of combination of two treatments for 2 to 2.5 hours and once a week. Control group: They only receive drug treatment(Use of metformin according to the instructions of an endocrinologist). Adherence therapy. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Madanlu Therapy Adherence Questionnaire (2013). Diabetic Self-Care. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Diabetes Self-Care Questionnaire. Health status. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Questionnaire Walker Health. Perceived Stress. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Cohen, Kamak and Marmerstein (1983) Perceived Stress Scale. Lifestyle. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Promoting Lifestyle Questionnaire (1983). Quality of life. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Quality of Life Questionnaire 36 questions. Adherence of treatment. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Madanlu Therapy Adherence Questionnaire (2013). The amount of self-care. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Diabetes Self-Care Questionnaire. Health status. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: World Health Organization Health Status. Lifestyle level. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Questionnaire Walker Health Promoting Lifestyle Questionnaire (1983). En Level of quality of life. Timepoint: Before an intervention, immediately after the intervention, 2months after the end of intervention. Method of measurement: Quality of Life Questionnaire 36 questions. Level of Perceived stress. Timepoint: Before an intervention, immediately after the intervention, 2 months after the end of intervention. Method of measurement: Cohen, Kamak and Marmerstein (1983) Perceived Stress Scale. University of Tehran Approved 2021-11-06 Ethics Committee of the Faculty of Psychology and Educational Sciences, University of Tehran Tehran - Shahid Chamran Highway - Under Nasr Bridge (Gisha) Tehran Tehran Iran (Islamic Republic of)