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IRCT20111105008011N2 IRCT 2021-04-11 Shiraz University of Medical Sciences Evaluating of Health Improvement Program in Caregivers of Patients with Schizophrenia based on Watson’ Theory Evaluating of Health Improvement Program in Caregivers of Patients with Schizophrenia based on Watson’ Theory 2021-04-21 anticipated 72 Complete https://irct.ir/trial/55040 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, we will contact individuals who meet eligibility criteria from whose information is recorded in the psychiatric center. We will invite 72 people to a briefing session and obtaining informed consent. (the number of participants has been calculated with the Med-calc statistical software with 80% power and 5% error and considering a possible drop of 20%). In the next step, we will consider a cod for each person. Then, for a simple random assignment with a random number table, participants are divided into two groups (by starting sampling from a point on the right side of a line of the table based on a random sequence such as even and odd numbers). Again, the two groups will randomly be divided into intervention and control groups (Solomon four-group design). In this way, we will have four groups of 18 people (two intervention groups and two control groups). N/A Caregivers of schizophrenia patients. Intervention 1: Intervention group 1: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session. Intervention 2: Intervention group 2: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session. Intervention 3: Control group 1: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group. Intervention 4: Control group 2: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group. Yes - There is a plan to make this available What will be shared: IPD, Analysis, Clinical trial study report When: From one month after the end of the study To whom: Researchers and Clinical Practitioners Conditions: For clinical and research use Where to obtain: Ladan Zarshenas How to obtain: By request, explanation and sending via email Comments:
public Shahpar Bagheri
Zand Street
Shiraz Iran (Islamic Republic of) 713451359 (+98 71) 36 47 42 54-8 shbagheri@sums.ac.ir Shiraz University of Medical Sciences scientific Ladan Zarshenas
Zand street
Shiraz Iran (Islamic Republic of) 713451359 (+98 71) 36 47 42 54-8 zarshenasster@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Over 18 years old Main family caregiver of patients with schizophrenia for at least one year 18 years no limit Both Unable to understand the study procedures Under treatment for mental illnesses F20 Schizophrenia Lifestyle Lifestyle Lifestyle Lifestyle Intervention group 1: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session. Intervention group 2: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session. Control group 1: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group. Control group 2: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group. Well-being. Timepoint: Before and four weeks after the intervention. Method of measurement: Caregiver well-being Scale. Shiraz University of Medical Sciences Approved 2019-06-09 Ethics committee of Shiraz University of Medical Sciences School of Nursing and Midwifery, Nemazee Square, Zand St. Shiraz Fars Iran (Islamic Republic of)