Investigating the Effect of A Group Compassion-based Program on Social Isolation and Depression of Family Caregivers of Patients with Multiple Sclerosis
Determining the effect of a group compassion-based program on social isolation and depression of family caregivers of patients with multiple sclerosis referring to selected centers of Isfahan University of medical sciences in 2023
Design
Two parallel groups randomized clinical trial, with a control group, on 60 family caregivers of patients with Multiple Sclerosis. The sample units will be randomly assigned into two equal groups.
Settings and conduct
Participants of intervention group will be enrolled in weekly sessions in classrooms of Al-Zahra and Kashani hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria for caregivers:
Age between 18 and 70 years
Minimum level of literacy needed for reading and writing
Consent to participate in study
If the patient has more than one caregiver, the caregiver who spends more time with the patient
The physical ability to participate in class sessions for at least two hours
The mental capacity to participate in the educational program without a self-reported learning or memory disorder
No history of depression or any other disease affecting social interactions
Caregiver of only a single person
Exclusion criteria for caregivers:
Unwillingness to continue to participate
Absence in class sessions for more than two sessions
Diagnosis of depression or any other disease affecting social interactions during the study
Inclusion criteria for patients:
Expanded disability status scale ranging from 2 to 9.5
No history of other chronic diseases
Diagnosed with Multiple Sclerosis for at least six months
Exclusion criteria for patients:
Patients' death or relapse of symptoms
Unwillingness to continue to cooperate
Intervention groups
Intervention group: six weekly in-person sessions of CFT-based educational program
Control group: no intervention
Main outcome variables
Depression score in BDI-II
Social isolation score in UCLA loneliness scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059233N1
Registration date:2023-11-01, 1402/08/10
Registration timing:prospective
Last update:2023-11-01, 1402/08/10
Update count:0
Registration date
2023-11-01, 1402/08/10
Registrant information
Name
Fatemeh Nabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 078 3314
Email address
fatemehnabi99@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of A Group Compassion-based Program on Social Isolation and Depression of Family Caregivers of Patients with Multiple Sclerosis
Public title
Study of Effects of Group CFT on Social Isolation and Depression in Patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Nursing, Rehabilitation and Management schools- Isfahan University of
Street address
Hezar Jarib Ave., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-10-28, 1402/08/06
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.128
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, immediately after the intervention, and two months after the intervention
Method of measurement
Beck Depression Inventory II
2
Description
Social isolation
Timepoint
Before intervention, immediately after the intervention, and two months after the intervention
Method of measurement
Russell's UCLA Loneliness Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Mehrdad Noroozi
Street address
Shohadaye Sofeh Ave., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
7573181746
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Mojtaba Rahimi
Street address
Ayatollah Kashani Ave., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Fax
Email
kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahin Shirani
Street address
Hezar Jarib Ave., Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Web page address
https://mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hojatollah Yousefi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 913 302 2900
Fax
Email
yousefi@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hojatollah Yousefi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8431919795
Phone
+98 913 302 2900
Fax
Email
yousefi@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Nabi
Position
MSN student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Bazr No. 80, Navab Safavi Ave., Dorcheh, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8431919795
Phone
+98 913 078 3314
Fax
Email
fatemehnabi99@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available