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IRCT20251031067832N1 IRCT 2026-04-24 Tehran University of Medical Sciences Investigating the Impact of Self-Compassion education on the Family Caregiver reaction of older adults with chronic disease Investigating the Impact of Self-Compassion education on the Family Caregiver reaction of older adults with chronic disease 2025-12-21 anticipated 70 Complete https://irct.ir/trial/87233 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: This study is a randomized controlled trial aiming to evaluate the effect of self-compassion training on the reactions of family caregivers of elderly people with chronic diseases. Seventy eligible caregivers from one urban comprehensive health center will be selected. Participants will be randomly assigned to intervention and control groups using block randomization with a block size of four. The random sequence will be generated by Random Allocation Software, and allocation concealment will be ensured using opaque, sealed, and sequentially numbered envelopes, Blinding description: This study will be conducted as a single-blind randomized controlled trial. Due to the nature of the educational intervention, it is not possible to blind the participants or the intervention facilitator. However, to minimize assessment bias, the data collector and statistical analyst will be blinded to group allocation. Participants will be instructed not to disclose their group assignment to the assessor. The coding of data will be done by an independent researcher, and only after the completion of data analysis will the groups be revealed. This approach ensures partial blinding and reduces the risk of subjective bias in data evaluation. N/A The studied condition is family caregiver stress and burden resulting from caring for older adults with chronic disease. It refers to the emotional, physical, and social strain experienced by family caregivers.. Intervention 1: intervention group: The intervention group will receive a self-compassion training program. This program consists of 8 45-minute sessions, twice a week, the content of which is designed based on the book The Mindful Self-Compassion Workbook by Germer and Neff. To develop the sessions, exercises such as compassionate statements, kindness meditation, writing practice, and relaxing physical contact practice, which are mentioned in detail at the end of each chapter, are used as the content framework of the sessions. The content of the sessions will include training in skills such as understanding and accepting difficult emotions, mindfulness, reducing self-criticism, cultivating kindness towards oneself and others, emotional empowerment, resilience, and creating self-compassionate motivation in the caregiving process. The training will be provided in person and will be supplemented with an educational booklet and educational videos. Additionally, to enhance learning, supplementary content including motivational and self-compassionate messages, short educational clips, and introductions to relevant resources will be provided to caregivers via social media. Intervention 2: Control group: The control group receives no intervention and simply continues their usual care. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to confidentiality concerns and ethical considerations, individual participant data will not be shared. The study involves sensitive information from family caregivers of elderly individuals with chronic diseases, and releasing such data may risk breaching participants’ privacy despite deidentification.
public Ahmadreza Khosravifar
No. 1470 , Opposite 16th Street (Farshi Moghaddam) , North Kargar Street , Tehran
Tehran Iran (Islamic Republic of) 1439957181 +98 905 838 0831 ahmadkhosravi191@gmail.com Tehran University of Medical Sciences scientific Ahmadreza Khosravifar
No. 1470 , Opposite 16th Street (Farshi Moghaddam) , North Kargar Street , Tehran
Tehran Iran (Islamic Republic of) 1439957181 +98 905 838 0831 ahmadkhosravi191@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Seniors with electronic records Continuous care of the elderly with chronic illness for at least 20.5 hours per week for 3 months Age over 18 years Family caregivers include spouse, children, friends, and relatives Access to a smartphone and the ability to operate it and access the internet Ability to speak Persian 18 years no limit Both Having a history of participating in self-compassion training classes Having psychological disorders based on caregivers' self-reports Cognitive diseases in elderly people under care Z63.8 Other specified problems related to primary support group Behavior N/A intervention group: The intervention group will receive a self-compassion training program. This program consists of 8 45-minute sessions, twice a week, the content of which is designed based on the book The Mindful Self-Compassion Workbook by Germer and Neff. To develop the sessions, exercises such as compassionate statements, kindness meditation, writing practice, and relaxing physical contact practice, which are mentioned in detail at the end of each chapter, are used as the content framework of the sessions. The content of the sessions will include training in skills such as understanding and accepting difficult emotions, mindfulness, reducing self-criticism, cultivating kindness towards oneself and others, emotional empowerment, resilience, and creating self-compassionate motivation in the caregiving process. The training will be provided in person and will be supplemented with an educational booklet and educational videos. Additionally, to enhance learning, supplementary content including motivational and self-compassionate messages, short educational clips, and introductions to relevant resources will be provided to caregivers via social media. Control group: The control group receives no intervention and simply continues their usual care Primary outcome variable: Caregivers’ reactions score measured by the Caregiver Reaction Assessment (CRA). This variable assesses the emotional, social, and physical responses of family caregivers of elderly individuals with chronic diseases before and after the self-compassion training intervention. Timepoint: The primary outcome (caregivers’ reactions score) will be measured before the intervention (baseline), immediately after the completion of the self-compassion training program (8 weeks after the start), and one month after the intervention to assess the sustainability of the effect. Method of measurement: The primary outcome variable (caregivers’ reactions) will be measured using the Caregiver Reaction Assessment (CRA) questionnaire, a validated self-report instrument that evaluates emotional, social, and physical responses of family caregivers of elderly individuals with chronic diseases. The CRA consists of multiple subscales scored on a Likert scale. Tehran University of Medical Sciences Approved 2025-11-01 Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran University of Medical Scienc No. 1470 , Opposite 16th Street (Farshi Moghaddam) , North Kargar Street , Tehran Tehran Tehran Iran (Islamic Republic of)