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IRCT20230823059233N1 IRCT 2023-11-01 Esfahan University of Medical Sciences Study of Effects of Group CFT on Social Isolation and Depression in Patients with Multiple Sclerosis Investigating the Effect of A Group Compassion-based Program on Social Isolation and Depression of Family Caregivers of Patients with Multiple Sclerosis 2023-12-21 anticipated 60 Complete https://irct.ir/trial/73412 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Using the online method of randomization, participants will be randomly assigned into intervention or control groups by the online random number calculator of the GraphPad® website; the procedure consists of the assignment of a random number - from 1 to 60 - to each participant, and then the online calculator will assign the numbers into two equal groups. N/A Multiple Sclerosis. Intervention 1: Intervention group: The intervention is an in-person educational program of six 120-minutes sessions based on Gilbert's CFT protocol. The participants of intervention group will be divides into three equal groups of ten participants, with each group receiving six in-person 120-minutes group CFT sessions weekly held in the classrooms of selected centers. The first session consists of preliminary communication with and introduction to caregivers, a review of educational program, and introduction to general principles of compassion. Second session teaches mindfulness, breathworks, and body scan basics, ending with a scheduled exercise for next week for participants. The third session introduces the participants to the attributes of a compassionate person. The fourth session focuses on the compassion skills (including compassionate reasoning, attention, feeling, sensations, imagery, and behavior). The fifth session teaches participants the readiness and acceptance of future events. The sixth (and final) session teaches how to write compassionate letters and concludes with a review of previous sections. The certified researcher will be the holder of all sessions under the supervision of the advisor of the study. The content of each session will be presented through face-to-face education using PowerPoint slides and educational pamphlets designed by the researcher. At the end of each session, the participants will receive at-home exercises. The researcher will observe the practice of exercises by caregivers at the same session. The repeated practice will be encourages, and the caregivers will be asked to verbally report about their practices in the next session. The caregivers will be given the phone number of the researcher in case of any question or issue. Intervention 2: Control group: The control group will receive no intervention. In accordance to ethical and professional principles if the effectiveness of the educational program is confirmed, the control group will have access to the recorded educational content. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information available
public Hojatollah Yousefi
Hezarjarib
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 302 2900 yousefi@nm.mui.ac.ir Esfahan University of Medical Sciences scientific Hojatollah Yousefi
Hezarjarib
Isfahan Iran (Islamic Republic of) 8431919795 +98 913 302 2900 yousefi@nm.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) A minimum age of 18 and maximum age of 70 years old for the caregivers Minimum level of literacy needed for reading and writing for the caregivers Caregivers' consent to participate in study If the patient has more than one caregiver, the caregiver who spends more time with the patient than others The physical ability of caregivers to participate in the in-person educational program for at least two hours The mental capacity of caregivers to participate in the educational program without a self-reported learning or memory disorder Expanded disability status scale ranging from 2 to 9.5 for patients Diagnosed with Multiple Sclerosis for at least six months 18 years 70 years Both Self-reported history of depression or any other disease affecting social interactions for caregivers Being the caregiver of more than a single person for caregivers History of other chronic diseases for patients G35 Multiple sclerosis Treatment - Other N/A Intervention group: The intervention is an in-person educational program of six 120-minutes sessions based on Gilbert's CFT protocol. The participants of intervention group will be divides into three equal groups of ten participants, with each group receiving six in-person 120-minutes group CFT sessions weekly held in the classrooms of selected centers. The first session consists of preliminary communication with and introduction to caregivers, a review of educational program, and introduction to general principles of compassion. Second session teaches mindfulness, breathworks, and body scan basics, ending with a scheduled exercise for next week for participants. The third session introduces the participants to the attributes of a compassionate person. The fourth session focuses on the compassion skills (including compassionate reasoning, attention, feeling, sensations, imagery, and behavior). The fifth session teaches participants the readiness and acceptance of future events. The sixth (and final) session teaches how to write compassionate letters and concludes with a review of previous sections. The certified researcher will be the holder of all sessions under the supervision of the advisor of the study. The content of each session will be presented through face-to-face education using PowerPoint slides and educational pamphlets designed by the researcher. At the end of each session, the participants will receive at-home exercises. The researcher will observe the practice of exercises by caregivers at the same session. The repeated practice will be encourages, and the caregivers will be asked to verbally report about their practices in the next session. The caregivers will be given the phone number of the researcher in case of any question or issue. Control group: The control group will receive no intervention. In accordance to ethical and professional principles if the effectiveness of the educational program is confirmed, the control group will have access to the recorded educational content. Depression. Timepoint: Before intervention, immediately after the intervention, and two months after the intervention. Method of measurement: Beck Depression Inventory II. Social isolation. Timepoint: Before intervention, immediately after the intervention, and two months after the intervention. Method of measurement: Russell's UCLA Loneliness Scale questionnaire. Esfahan University of Medical Sciences Approved 2023-10-28 Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of Hezar Jarib Ave., Isfahan City Isfahan Isfehan Iran (Islamic Republic of)