Determining the effectiveness of family psychoeducation intervention on the psychological burden and perceived stress of caregivers of patients with bipolar disorder
Design
The clinical trial has a control group and is randomized and nonblinded on 72 people. The block randomization method generated by Random Allocation Software was used for randomization.
Settings and conduct
The level of psychological burden and perceived stress will be assessed by the research members using the Zarit Psychological Burden Questionnaire and the Perceived Stress Questionnaire. Then, the intervention group will undergo psychological education sessions on bipolar disorder. The educational sessions will be held at Shahid Yahyanejad Hospital. Then, the aforementioned questionnaires will be completed again by the control and intervention groups after the end of the intervention and three months after the end of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria for caregivers:
Age 18-60 years
At least fifth grade education
Individuals from the patient's first-degree family who are consistently responsible for caring for him/her
Caregivers whose patients have had at least two mood episodes during the course of the disease
Criteria for excluding caregivers from the study:
People who have a history of psychiatric disorder or physical illness that affects their role in caring for the patient
People who have a history of participating in similar training sessions or are currently participating in other similar training sessions at the time of the study.
Intervention groups
For individuals in the study group, education on bipolar disorder will be provided by the resident responsible for implementing the project during four forty-five-minute sessions held over two weeks.
Main outcome variables
Psychological burden؛ perceived stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250609066133N1
Registration date:2025-07-10, 1404/04/19
Registration timing:prospective
Last update:2025-07-10, 1404/04/19
Update count:0
Registration date
2025-07-10, 1404/04/19
Registrant information
Name
Maryam Haghjou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3222 3594
Email address
haghjou29@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-07-16, 1404/04/25
Expected recruitment end date
2025-10-22, 1404/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of family Psychoeducational Intervention on the Burden and perceived stress of Caregivers of Patients with Bipolar Disorder
Public title
The Effectiveness of family Psychoeducational Intervention on the Burden and perceived stress of Caregivers of Patients with Bipolar Disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
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.
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 Health Research Institute - Babol University of Medical Sciences
Street address
Babol University of Medical Sciences , Ganafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2025-05-18, 1404/02/28
Ethics committee reference number
IR.MUBABOL.HRI.REC.1404.024
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
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
2
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yahyanejad hospital
Full name of responsible person
Maryam Haghjou
Street address
Shahid Mostafa Khomeini Ave.,Modarres Blvd
City
Babol
Province
Mazandaran
Postal code
۴۷۱۳۶۵۵۶۴۷
Phone
+98 11 3222 3594
Email
haghjou29@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Vice_chanceller Of Research., Daneshgah Square., Ganjafrooz Avenue
City
babol
Province
Mazandaran
Postal code
4717641367
Phone
+98 11 3219 7667
Email
Src.mubabol@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Maryam Haghjou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Modarres Street,Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3222 3594
Fax
Email
haghjou29@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Haghjou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Modarres Street,Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3222 3594
Fax
Email
haghjou29@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Haghjou
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Modarres Street,Shahid Yahyanejad Hospital
City
Babol
Province
Mazandaran
Postal code
4713655647
Phone
+98 11 3222 3594
Fax
Email
haghjou29@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
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 the data will become available and for how long
Start of access period since 2025
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
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.
From where data/document is obtainable
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
What processes are involved for a request to access data/document
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.