The effect of self-awareness skills on stigma in family caregivers of patients with bipolar disorder type 1
Design
A clinical trial with a control group with parallel groups randomized by block method is conducted on 49 samples.
Settings and conduct
In Ibn Sina Hospital of Mashhad, intervention is held in the form of educational sessions
Participants/Inclusion and exclusion criteria
Entry criteria for caregivers: first-degree relative of the patient who is the main caregiver of the patient. High school education, living in Mashhad and Iranian nationality, age at least 18 and at most 60 years old, no physical, hearing and visual impairments, no known mental disorders and no drug use in this context, no experience of another crisis such as divorce and Death of loved ones in the last six months, lack of medical education.
Criteria for the admission of patients: Confirmation of a patient with type 1 bipolar disorders by a psychiatrist, at least six months have passed since the diagnosis of the disease, and have a history of at least one previous hospitalization in a psychiatric hospital.
Intervention groups
After determining the subjects and completely identical conditions, the pre-test will be performed for the test and control groups. The training of self-awareness skills will be done in a group for a period of 4 weeks, twice a week in 8 sessions of 35 minutes. Also, one month after the end of the intervention, the control group will be invited to participate in the self-awareness training session.
Main outcome variables
In the control group, it is expected that our intervention will reduce the stigma score and also they will behave carefully in dealing with everyday life issues.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231014059720N1
Registration date:2023-10-30, 1402/08/08
Registration timing:prospective
Last update:2023-10-30, 1402/08/08
Update count:0
Registration date
2023-10-30, 1402/08/08
Registrant information
Name
Amir Fallah Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 1942
Email address
fallahamir1992@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-14, 1402/09/23
Expected recruitment end date
2024-01-13, 1402/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Self-Awareness Skills on Stigma in Family Caregivers of Patients with Bipolar Disorder type 1
Public title
The Effect of Self-Awareness Skills on Stigma in Family Caregivers of Patients with Bipolar Disorder type 1
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Entry criteria for caregivers: first-degree relative of the patient who is the main caregiver of the patient.
High school education
living in Mashhad and Iranian nationality
age at least 18 and at most 60 years old
no physical, hearing and visual impairments
no known mental disorders and no drug use in this context
no experience of another crisis such as divorce and Death of loved ones in the last six months
lack of medical education
Criteria for the admission of patients: Confirmation of a patient with type 1 bipolar disorders by a psychiatrist
at least six months have passed since the diagnosis of the disease
and have a history of at least one previous hospitalization in a psychiatric hospital.
Exclusion criteria:
to be absent in one of the training sessions
After completing the training process, the main caregiver of the patient experiences such things as divorce or the death of a loved one until the post-test
During the research, participate in another educational program in this field.
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:
49
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked
In order to randomly assign patients to study subjects while ensuring equal numbers in study groups, random permutation block method is used. For this purpose, blocks with sizes 2 and 4 are used, and a random list will be created through the website https://www.sealedenvelope.com.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
No.31,27th Salman Farsi Ave.
City
Sabzevar
Province
Razavi Khorasan
Postal code
9657134991
Approval date
2023-10-08, 1402/07/16
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.082
Health conditions studied
1
Description of health condition studied
Bipolar type 1
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
The effect of self-awareness skill training on the stigma of family caregivers
Timepoint
before and one month after the end of the intervention
Method of measurement
Ritscher et al.'s internal stigma questionnaire of mental patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The study population is the caregivers of patients with bipolar disorder type 1 hospitalized in the educational or therapeutic adult departments of Ibn Sina Hospital. Caregivers of patients who are interested in participating in the research will be invited. Then, a meeting will be held to state the objectives of the study, informed and written consent will be obtained from the caregivers of the patients, and they will be asked to complete the demographic checklist and the standard questionnaire of internal stigma of psychiatric patients by Ritscher et al. The sample size has been calculated by considering 20% attrition for the group of 49 people. The intervention group will undergo self-awareness training for 4 weeks in the form of two 35-minute sessions per week (8 sessions), which are as follows.The intervention is taken from the book Life Skills Training authored by Hamed Barabadi, and in each session, first a brief explanation about the activity that is to be done, and then homework is completed in the classroom and at home. The assignments are classified as the mentioned items. 1- Definition of self-awareness 2- Definition of real self and ideal self 3- Emotions and its components 4- Self-image 5- Self-esteem 6- Trophy of victory 7- Filling placards of success 8- Introducing sources of self-awareness. After one month of the intervention, the questionnaires will be completed again by this group.
Category
Other
2
Description
Control group: In the control group, after filling the relevant questionnaire, they do not receive any intervention and they only receive the usual interventions of the hospital, and after our interventions are completed and the questionnaire form is completed by the intervention group, the control group is invited to act after one month. come to receive the interventions taken from the life skills training book in one session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Hospital, Mashhad
Full name of responsible person
Saeed Vaghee
Street address
Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
VagheeS@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Street address
Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
VagheeS@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
VagheeS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Vaghee
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Educational complex of Shahid Dr. Kharazmi, university campus, east gate of Ferdowsi University of Mashhad, Azadi Square, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
VagheeS@mums.ac.ir
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
Its main implications are shared
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
It is accessible to all people
Under which criteria data/document could be used
The person to whom the data is sent must have a university degree in psychiatry or psychology and for what purpose he requests this information.
From where data/document is obtainable
09050476711
Fallah Moghaddam Amir
What processes are involved for a request to access data/document
An email will be sent to him during a phone call with the number 09050476711, and after his request, information will be sent to him through the given email within a month.