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IRCT20231126060197N1 IRCT 2023-12-07 Shiraz University of Medical Sciences The effect of group education on depression The effect of group education on self-care self-efficacy of adolescents with depressive disorder 2024-01-21 anticipated 96 Complete https://irct.ir/trial/74013 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: People with conditions are randomly placed in two intervention and control groups. Random allocation method in this study is permutation block method in such a way that A represents the person who receives the intervention and B represents the person who does not receives the intervention. This method is implemented considering blocks of 4 so that the total number of possible permutations of four is equal to 6. (blocks of four included: BBAA, AABB, BABA, BAAB, ABBA, ABAB) The desired random list of 96 items, which includes 4 blocks of 6 items, is produced and the order of allocation of each of the participant samples in the intervention and control groups of the study is determined. The way to use the table of random numbers is to choose the starting point randomly, Blinding description: This study is done in a one-sided blind method by the person who did the data analysis and statistical analysis. N/A Major depressive disorder. Intervention 1: Intervention group: There are 48 patients in this group, which are divided into 6 groups of 8 people. Girls and boys are placed in separate groups. The people of each group are tried to be in the same age category. After completing the informed consent form, doing the pre-test and familiarization with study implementation method, 10 sessions of group educational intervention for 90 minutes will be provided to the intervention groups twice a week. The content of the educational intervention, in order to improve self-care self-efficacy, is based on the concepts obtained from Behzadi et al.'s research, which includes 4 main themes and each theme has 3 sub-themes: 1- Adaptive coping (emotional-oriented coping, problem-oriented coping and spiritual approach) 2- Social self-care (effective social interactions, acquiring social competence and management of high-risk behaviors) 3- Life adaptation to disease and treatment condition (healthy life style, management of complications caused by treatment and treatment adherence) 4- Health information seeking behaviors (searching for practical resources, assessing the quality of the information and how to use the information optimally). Intervention 2: Control group:. Yes - There is a plan to make this available What will be shared: Informed consent form, non-identifiable data of participants, the study protocol and the report of clinical study When: The access period starts 6 months after the results are published. To whom: The research team, researchers working in academic and scientific institutions as well as people working in industry. Conditions: For the mentioned people with information of project manager. Where to obtain: The main executive of project: Dr. Shahrzad Yektatalab E-mail: yektash@sums.ac.ir Tel: +98 71 3647 4254 How to obtain: With the information and coordination of project manager. Comments:
public Dr. Shahrzad Yektatalab
Nursing Department, School of Nursing and Midwifery, Nemazee Sq., Zand Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 yektash@sums.ac.ir Shiraz University of Medical Sciences scientific Dr. Shahrzad Yektatalab
Nursing Department, School of Nursing and Midwifery, Nemazee Sq., Zand Blvd., Shiraz
Shiraz Iran (Islamic Republic of) 7193613119 +98 71 3647 4254 yektash@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age 12-18 years old Willingness to participate in the study Parents' consent to adolescent participation in the study Preparation and favorable physical and mental conditions of the patient to participate in the intervention Having DSM-5 diagnostic criteria for depression Suffering from a depressive disorder based on the psychiatrist's diagnosis and the score obtained from the depression assessment questionnaire 12 years 18 years Both Refusal to continue participating in the study during the study The occurrence of a crisis or an unforeseen event affecting the patient's mental state Inability to actively participate in the treatment process due to reasons such as slowness of thinking, slowness of speech, etc Presence of other accompanying psychiatric and cognitive disorders based on interview and doctor's diagnosis F32 Major depressive disorder, single episode Lifestyle N/A Intervention group: There are 48 patients in this group, which are divided into 6 groups of 8 people. Girls and boys are placed in separate groups. The people of each group are tried to be in the same age category. After completing the informed consent form, doing the pre-test and familiarization with study implementation method, 10 sessions of group educational intervention for 90 minutes will be provided to the intervention groups twice a week. The content of the educational intervention, in order to improve self-care self-efficacy, is based on the concepts obtained from Behzadi et al.'s research, which includes 4 main themes and each theme has 3 sub-themes: 1- Adaptive coping (emotional-oriented coping, problem-oriented coping and spiritual approach) 2- Social self-care (effective social interactions, acquiring social competence and management of high-risk behaviors) 3- Life adaptation to disease and treatment condition (healthy life style, management of complications caused by treatment and treatment adherence) 4- Health information seeking behaviors (searching for practical resources, assessing the quality of the information and how to use the information optimally) Control group: Self-care self-efficacy. Timepoint: Measurement of self-care self-efficacy at the beginning of the study (1st session) and at the end of the intervention (10th session). Method of measurement: Behzadi et al.'s self-care self-efficacy of adolescents with mental disorders questionnaire, Beck depression inventory. Shiraz University of Medical Sciences Approved 2023-11-25 Ethics committee of Shiraz University of Medical Sciences Central department of Shiraz University of Medical Sciences, Zand St., Shiraz Shiraz Fars Iran (Islamic Republic of)