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IRCT20250609066133N1 IRCT 2025-07-10 Babol University of Medical Sciences The Effectiveness of family Psychoeducational Intervention on the Burden and perceived stress of Caregivers of Patients with Bipolar Disorder The Effectiveness of family Psychoeducational Intervention on the Burden and perceived stress of Caregivers of Patients with Bipolar Disorder 2025-07-16 anticipated 72 Complete https://irct.ir/trial/84291 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Block randomization will be used to assign target group patients to one of the two study groups. Then, participants will be assigned to one of the two intervention and control groups in blocks of six in a 1:1 ratio according to the block randomization protocol (generated by Random Allocation Software), so that the researcher cannot predict which intervention group the next person will be placed in. In order to conceal the random allocation, the codes generated by the software will be placed in opaque envelopes so that it is not clear which group the next person will be placed in. N/A Bipolar disorder. Intervention 1: Intervention group: Individuals in this group will receive training on bipolar disorder in four 45-minute sessions over two weeks, two sessions each week. The content will be taught by the resident implementing the project. The source of the information taught will be Kaplan and Sadock's Comprehensive Psychiatry, 11th edition, and the book Treatment of Bipolar Disorder: Cognitive Behavioral Approach. Intervention 2: Control group: The control group will not undergo psychological training as will be done for the intervention group. The level of care in this group will be the same as usual. Yes - There is a plan to make this available What will be shared: The participant data file will be published without publishing the names of the individuals, the study protocol, the statistical analysis map, the informed consent form, the clinical study report, the codes used in the analysis, and the data classification system after the end of the study. When: Start of access period since 2025 To whom: Researchers working in academic and scientific institutions Conditions: Permitted analyses include descriptive and inferential statistical analyses. Data may only be used for research and scientific purposes, including publication of articles and reports. Commercial use of the data is not permitted. Where to obtain: To receive the data, they can send their request to the email of the student responsible for the research, Maryam Haghjou .Adress:haghjou29@gmail.com How to obtain: The applicant must submit a formal request including the purpose and type of data. The request is sent to the review committee and usually takes 1 to 2 weeks to evaluate. The applicant is notified after the request is approved or rejected. If approved, a privacy agreement must be signed. The data is sent to the applicant after the agreement is signed, which may take 1 to 3 weeks. Comments:
public Maryam Haghjou
Modarres Street,Shahid Yahyanejad Hospital
Babol Iran (Islamic Republic of) 4713655647 +98 11 3222 3594 haghjou29@gmail.com Babol University of Medical Sciences scientific Maryam Haghjou
Modarres Street,Shahid Yahyanejad Hospital
Babol Iran (Islamic Republic of) 4713655647 +98 11 3222 3594 haghjou29@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Age from 18 to 60 At least fifth grade education People from the patient's immediate family who are permanently responsible for his or her care Caregivers whose patients have had at least two mood episodes during the course of their illness 18 years 60 years Both F31 Bipolar disorder Prevention N/A Intervention group: Individuals in this group will receive training on bipolar disorder in four 45-minute sessions over two weeks, two sessions each week. The content will be taught by the resident implementing the project. The source of the information taught will be Kaplan and Sadock's Comprehensive Psychiatry, 11th edition, and the book Treatment of Bipolar Disorder: Cognitive Behavioral Approach. Control group: The control group will not undergo psychological training as will be done for the intervention group. The level of care in this group will be the same as usual. Psychological burden score on the Zarit Psychological Burden Questionnaire. Timepoint: Measurement of psychological burden before the start of the intervention, after the intervention, and three months after its end. Method of measurement: Zarit burden interview. Perceived stress score on the Perceived Stress Test. Timepoint: Measurement of perceived stress at the beginning of the study, after the intervention, and three months after the intervention. Method of measurement: Perceived Stress Test. Babol University of Medical Sciences Approved 2025-05-18 Research Ethics Committees of Health Research Institute - Babol University of Medical Sciences Babol University of Medical Sciences , Ganafrooz Avenue Babol Mazandaran Iran (Islamic Republic of)