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IRCT20160924029954N14 IRCT 2020-11-23 Zahedan University of Medical Sciences the effect of cognitive-behavioral training along with motivational interviewing in comparison with cognitive-behavioral training on depression, medication adherence and level of hemoglobin A1C in type 2 diabetic patients with depression signs The effect of cognitive-behavioral education combined with motivational interviewing in comparison with cognitive-behavioral education on depression, drug adherence and hemoglobin A1C in patients with type 2 diabetes with depressive symptoms 2020-08-31 anticipated 90 Complete https://irct.ir/trial/51474 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: does not have, Randomization description: From patients diagnosed with type 2 diabetes referred to clinics based on inclusion criteria, by available sampling method, the patients will be selected. Due to the fact that the study population is patients with type 2 diabetes with depression, if they have general conditions, first with the help of Beck Depression Inventory, patients with a score above 21 are identified and then with clinical examination and mental status (MSE) of the depressed. The presence of patients with diabetes will be ensured as one of the most important inclusion criteria. Patients with depressive type 2 diabetes who are selected in this way will be randomly assigned to two groups of cognitive-behavioral education with motivational interview and cognitive-behavioral education. Thus, 90 colored balls (45 white balls for cognitive-behavioral education) And 45 red balls for cognitive-behavioral training combined with motivational interviews) randomly taken out of the container and based on the color of the extracted ball, group membership will be recorded on the list, respectively. By referring to the research environment and selecting and entering eligible patients, gradually and in order of the list, the membership of each patient will be determined in the order of inclusion in the study and the relevant intervention will be performed about him. N/A Condition 1: Diabetic patients. Condition 2: depressive disorder. Intervention 1: Intervention group: Intervention procedure: 1: Cognitive-behavioral training with motivational interview: 8 sessions of cognitive-behavioral training with motivational interview Three sessions per week (each session averages 90 to 100 minutes with a break time in each session). Content of motivational interview sessions Session 1: Start the session, introduce the motivational approach and determine the rules of the group. ● Practice determining the stages of change and determining the stage of change ● Ending the session ● Session 2: Start the session and introduce the topic ● Describe one by one the self-care behaviors during the day ● Discuss the activities ● Discuss the Complications of carelessness ● Ending the session ● Session 3: Starting the session and introducing the values ​​and how to determine its hierarchy ● Discovering the conflict between individual values ​​and health-related behaviors ● Introducing and practicing identifying positive dimensions and Negative behavior change ● Measuring the balance of decision-making and ending the session ● Session 4: Start the session and introduce the topic and identify motivators ● Tempters, confidence in behavior control and self-confidence ● Goal setting, vision and Preparing a plan and behavior change plan. دادن Ending the session. Content of cognitive-behavioral sessions: First session: ● Starting the session and introducing the cognitive-behavioral model, determining the group rules ● Familiarity with ABC sheets related to RET treatment Session 2: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effect of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce Awa Diabetes ● Concern or Anxiety ● Coping with Anxiety ● Ending Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending Sessions and Periods. Intervention 2: Intervention group: Intervention group 4: 2 sessions of cognitive-behavioral training 2 sessions per week (face to face and with the help of audio-visual aids): Content of cognitive-behavioral sessions: First session: ● Start the session and introduce the cognitive-behavioral model ● Familiarity with sections D and E of ABC worksheet ● End the session and assign the second session: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effects of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce complications ● Worrying or Anxiety ● Coping with Anxiety ● Ending the Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending the Session and Period. No - There is not a plan to make this available Justification or reason for not sharing IPD is Participants information is confidential
public Zahra Miri
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
zahedan Iran (Islamic Republic of) 9916713335 +98 54 3721 2364 mirizahra174@gmail.com Zahedan University of Medical Sciences scientific Ali Navidian
Field Of Fame - Zahedan Nursing And Midwifery Faculty
zahedan Iran (Islamic Republic of) 9816913396 +98 54 3344 2482 alinavidian@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Hemoglobin a1c in the amount of 8 and more Obtaining a score of 21 from the Beck Depression Inventory and confirming depression in the mental state examination No other psychiatric illnesses 6 months to 1 year of illness Full consciousness and no communication problem No addiction and substance abuse No history of participating in a counseling or training rehabilitation program at the same time Willingness to participate in the study Diagnosis of type 2 diabetes based on the patient's record Age range 20 to 60 years 20 years 60 years Both Critical illness, hospitalization, death, or any unexpected events during the study Do not attend more than one treatment session E08 F32 Diabetes mellitus due to underlying condition Major depressive disorder, single episode Behavior Behavior Intervention group: Intervention procedure: 1: Cognitive-behavioral training with motivational interview: 8 sessions of cognitive-behavioral training with motivational interview Three sessions per week (each session averages 90 to 100 minutes with a break time in each session). Content of motivational interview sessions Session 1: Start the session, introduce the motivational approach and determine the rules of the group. ● Practice determining the stages of change and determining the stage of change ● Ending the session ● Session 2: Start the session and introduce the topic ● Describe one by one the self-care behaviors during the day ● Discuss the activities ● Discuss the Complications of carelessness ● Ending the session ● Session 3: Starting the session and introducing the values ​​and how to determine its hierarchy ● Discovering the conflict between individual values ​​and health-related behaviors ● Introducing and practicing identifying positive dimensions and Negative behavior change ● Measuring the balance of decision-making and ending the session ● Session 4: Start the session and introduce the topic and identify motivators ● Tempters, confidence in behavior control and self-confidence ● Goal setting, vision and Preparing a plan and behavior change plan. دادن Ending the session. Content of cognitive-behavioral sessions: First session: ● Starting the session and introducing the cognitive-behavioral model, determining the group rules ● Familiarity with ABC sheets related to RET treatment Session 2: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effect of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce Awa Diabetes ● Concern or Anxiety ● Coping with Anxiety ● Ending Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending Sessions and Periods. Intervention group: Intervention group 4: 2 sessions of cognitive-behavioral training 2 sessions per week (face to face and with the help of audio-visual aids): Content of cognitive-behavioral sessions: First session: ● Start the session and introduce the cognitive-behavioral model ● Familiarity with sections D and E of ABC worksheet ● End the session and assign the second session: ● Start the session and introduce the topic of stress and diabetes ● Discuss the effects of stress on diabetes ● Teach stress management techniques ● End the session and present the task of the third session: ● Start the session and introduce complications ● Worrying or Anxiety ● Coping with Anxiety ● Ending the Session Session 4: ● Starting the Session and Introducing Diabetes and Social Relations ● Diabetes and Social Support ● Learning Ways to Increase Social Support ● Ending the Session and Period People whose Beck questionnaire score is above 21. Timepoint: "Measurement of depression at the beginning of the study and 3 months after the intervention". Method of measurement: Beck Depression Inventory. The score they get from the Drug Adherence Questionnaire. Timepoint: Measurement of drug adherence at the beginning of the study and three months after the intervention. Method of measurement: Moriski Drug Adherence Questionnaire. Percentage of globin a1c reported by the laboratory. Timepoint: Measurement of hemoglobin a1c at the beginning of the study and three months after the intervention. Method of measurement: Laboratory measurement of hemoglobin a1c. Zahedan University of Medical Sciences Approved 2020-08-09 Ethics Committee Of Zahedan University Of Medical Sciences & Health Services Administrative Complex Of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)