The effect of family-family support program on caregiver burden, general health and coping strategies of family members of patients with severe mental health disorders
Determining and comparing the level of caregiving burden, and general health and coping strategies before and after the intervention in both the intervention and control groups.
Design
This research is a randomized controlled intervention study to evaluate the effectiveness of the FFS program for families of patients with severe psychiatric illnesses such as schizophrenia, depression, or bipolar disorder in Iran. The study will include family members of inpatients in psychiatric hospitals. Sampling will be conducted using the convenience sampling method, with participants informed about the FFS program through hospital officials and provided with information leaflets. A meeting will be held to explain the program's objectives, content, and implementation to interested families.
The FFS program, developed with expert input and comprising eight sessions, covers topics such as psychiatric illness awareness and stress-coping strategies. Before the program, participants will complete caregiver burden scale, the GHQ and stress coping scale, with FFS group caregivers supported by those who completed a "train the trainer" course. Each session lasts 2 hours with an observation period and researcher support for caregiver-presenters. After the completion of the program, a booklet will be provided for caregivers to share knowledge.
Settings and conduct
Iran psychiatry hospital
Participants/Inclusion and exclusion criteria
They must be willing to participate in the study, literate, over 18 years of age, and the primary caregiver responsible for the care and treatment of a patient with severe psychiatric illness for at least 3 months. Exclusion criteria include not attending in three sessions and more of a total of eight sessions.
Intervention groups
Family-family support
Main outcome variables
Care-giver Burden
General Health
Coping strategies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100911004728N5
Registration date:2024-05-16, 1403/02/27
Registration timing:prospective
Last update:2024-05-16, 1403/02/27
Update count:0
Registration date
2024-05-16, 1403/02/27
Registrant information
Name
Hadi Ranjbar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 6862
Email address
ranjbar.h@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-20, 1403/03/31
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-family support program on caregiver burden, general health and coping strategies of family members of patients with severe mental health disorders
Public title
Family support in patients with mental health problem
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Literate
The main caregiver of the patient
Care for more than three months
Exclusion criteria:
Not participating in three and more sessions out of a total of eight sessions
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will occur during the initial meeting with families who are willing to participate. Caregivers who agree to take part in the trial will be randomly assigned to either the FFS group or the control group. Participants will be randomly provided with stickers labeled A and B, and informed that those with stickers marked A will be placed in the study group and those with stickers marked B will be placed in the control group.
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
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2024-01-01, 1402/10/11
Ethics committee reference number
IR.IUMS.REC.1402.876
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress, and adjustment disorders
Primary outcomes
1
Description
The caregiver burden
Timepoint
Before intervention, After intervention
Method of measurement
Caregiver buirden scale
2
Description
General Health
Timepoint
Before intervention, After intervention
Method of measurement
General Health scale
3
Description
Coping mechanisms
Timepoint
Before intervention, After intervention
Method of measurement
Stress coping strategies scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Family-family support program
Category
Behavior
2
Description
Control group: Routine follow up
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatry Hospital
Full name of responsible person
Hadi ranjbar
Street address
No1 navab St
City
Tehran
Province
Tehran
Postal code
1432345671
Phone
+98 21 4450 3395
Email
hadiranjbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2542
Email
hadiranjbar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2542
Fax
Email
hadiranjbar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2542
Fax
Email
hadiranjbar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hadi Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Tehran, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2542
Fax
Email
hadiranjbar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Starting after publication
To whom data/document is available
It will be available for people working in academic institutions
Under which criteria data/document could be used
The person responsible for general inquiries will review all requests and the data will provide for academic purposes
From where data/document is obtainable
All applicants should email their requests to mohebiaan@gmail.com
What processes are involved for a request to access data/document
All requests will assess in two weeks and the result will send to the applicants after assessment.