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IRCT20210920052525N1 IRCT 2021-10-23 Tarbiat Modares University The Effectiveness of Group Reality Therapy on Anxiety and Depression The Effectiveness of Group Reality Therapy on Anxiety and Depression of Iranian Family Caregivers of the Elderly with Multiple Chronic Conditions: A Randomized Controlled Trial Study 2021-10-02 anticipated 50 Complete https://irct.ir/trial/58843 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization: Step 1: Random sequence generation: Considering that the researchers of this study tend to have all sample groups with equal sample size, they used restricted randomization. In the present study, the method used in this type of randomization in order to create a balance in the number of samples assigned to each of the studied groups is block randomization. The placement of family caregivers of the elderly with several chronic diseases in two groups of intervention (reality therapy) and control (without intervention) was done by block random allocation method. The method of assigning 50 eligible samples to two groups of 25 is as follows: the method of 4 random blocks is used to assign family caregivers to the four groups studied. To do this, first write a list of blocks and assign numbers to them {(1) AABB- (2) ABAB- (3) ABBA- (4) BBAA- (5) BABA- (6) BAAB}. Then, using a table of random numbers, 13 random numbers between 1 to 6 are created and according to the mentioned numbers, the relevant block is selected and a random sequence is formed as a sequence of letters A and B (letter A for the test group and letter B for the control group). Step 2: Concealment of random allocation: To perform a random sequence on the study participants, Sequentially numbered, sealed, opaque envelopes are used. In such a way that the assigned group is not specified before the individual is assigned; A number of envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, envelopes are numbered in the same way on the outer surface of the envelopes. Finally, the lids of the letter envelopes are glued and placed inside the boxes, respectively. At the beginning of the registration of participants, one of the envelopes of the letter is opened and the assigned group of the participant is revealed, according to the order of entry of the eligible participants. Step 3: Execute the random allocation process: The student examines the participants in terms of inclusion and exclusion criteria in the study and registers them in the study. However, the person who assigns the participants to the groups will not be involved in the intervention and data collection of the participants. N/A Multiple Chronic Conditions. Intervention 1: Intervention group: Reality therapy intervention is done for a period of one month in the form of group training and twice a week. The sessions are conducted by the researcher (PhD student in nursing) and PhD in psychology on family caregivers in the intervention group with the aim of reducing their anxiety and depression. Topics of 8 sessions of reality therapy include "environment and assessment; providing information and flipping; explaining and understanding anxiety based on choice theory and reality therapy; familiarity with depression based on choice theory and the sacrifice triangle; communication skills training as a deterrent External control and its destructive effects mean anxiety and depression; communication skills (internal control and general behavior machine); intelligent planning (SMART PLAN); WDEP process to solve the problem. Intervention 2: Control group: They do not receive any intervention and only receives health and medical care that is specific to the elderly from medical centers or health centers. These cares include: health advice about caring for the chronic diseases of the elderly, how to take medication, medical visits. Yes - There is a plan to make this available What will be shared: The data obtained in relation to the target population of this study are related to demographic information and the two main outcomes of the study, namely anxiety and depression, which are reported anonymously and as a result of the analysis of the findings. When: Access period starts from 1401 To whom: Researchers in the field of nursing and psychology All health care providers Nursing politicians Conditions: Reference to the researchers of this study Where to obtain: Send a message to saharmalmir93@gmail.com How to obtain: Data is sent after obtaining permission from the supervisors Comments:
public Sahar Malmir
Alavi Street
Khorramabad Iran (Islamic Republic of) 6813963658 +98 66 3330 9193 saharmalmir93@gmail.com Tarbiat Modares University scientific Hassan Navipour
Tehran, Jalal Al-Ahmad, Nasr Bridge
Tehran Iran (Islamic Republic of) 111-14115 +98 21 6657 0089 naviporh@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Caring for an elderly family member with multiple chronic illnesses for at least three months Age 18-60 years Willingness to participate in the study Having literacy Being able to communicate and use a smartphone 18 years 60 years Both Participate in any other related research on geriatric care over the past two years Inability to take care of oneself and perform daily activities Having a severe mental disorder that requires medication Other N/A Intervention group: Reality therapy intervention is done for a period of one month in the form of group training and twice a week. The sessions are conducted by the researcher (PhD student in nursing) and PhD in psychology on family caregivers in the intervention group with the aim of reducing their anxiety and depression. Topics of 8 sessions of reality therapy include "environment and assessment; providing information and flipping; explaining and understanding anxiety based on choice theory and reality therapy; familiarity with depression based on choice theory and the sacrifice triangle; communication skills training as a deterrent External control and its destructive effects mean anxiety and depression; communication skills (internal control and general behavior machine); intelligent planning (SMART PLAN); WDEP process to solve the problem. Control group: They do not receive any intervention and only receives health and medical care that is specific to the elderly from medical centers or health centers. These cares include: health advice about caring for the chronic diseases of the elderly, how to take medication, medical visits. Anxiety. Timepoint: Before intervention and after intervention (End of a month). Method of measurement: Depression, Anxiety and Stress Questionnaire (DASS-21). Depression. Timepoint: Before intervention and after intervention (End of a month). Method of measurement: Depression, Anxiety and Stress Questionnaire (DASS-21). Tarbiat Modares University Approved 2019-05-07 Ethics Committees of Tarbiat Modares University Tehran, Jalal AleAhmad, Nasr,Tarbiat Modares University Tehran Tehran Iran (Islamic Republic of)