Protocol summary

Study aim
Determining the effect of emotion regulation program on social skills and perceived social stigma in patients with mood disorders
Design
This study is a clinical trial with a control group and it is performed on 60 samples that were placed in two groups of 30 people, control and test, using a simple random method. Randomization in this study is done using spss
Settings and conduct
The research environment is Khurshid and Farabi hospitals in Isfahan. The sample of our study will be patients diagnosed with depressive and bipolar mood disorders hospitalized in these centers. The adjustment program sessions will be conducted in 6 sessions of 30-45 minutes and in the form of groups of eight to ten patients for the intervention group and three times a week, by the student and with the supervision and accompaniment of the supervisor in the classroom of the department.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being hospitalized with a diagnosis of one of the depressive disorders, bipolar by a psychiatrist, being at least 18 years old Non-entry criteria: patient's unwillingness to continue attending, absence of more than two sessions, acute phase of the patient, causing any physical problem or discomfort to the patient.
Intervention groups
Intervention group: The sessions of the emotion regulation program will be conducted in 6 sessions of 30-45 minutes for the intervention group and three times a week in the classroom of the department. Control group: They will not receive any training program and at the end, the content of the sessions will be provided to the members of the control group
Main outcome variables
social skills and perceived social stigma

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039321N5
Registration date: 2024-02-04, 1402/11/15
Registration timing: prospective

Last update: 2024-02-04, 1402/11/15
Update count: 0
Registration date
2024-02-04, 1402/11/15
Registrant information
Name
sima ghezelbash
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7607
Email address
ghezelbash@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of emotion regulation program on social skills and perceived social stigma in patients with mood disorders
Public title
The effect of emotion regulation program on social skills and perceived social stigma
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. Diagnosed with one of the depressive disorders, bipolar, recorded by a psychiatrist in the patient's file. . The patient has passed the acute period of his illness, was in a relatively stable condition when entering the study, and was hospitalized in a non-acute ward In bipolar patients, the patient should not be in the mania phase . Patients should be in the adult age group (over 18 years old) The patient is willing to participate in the study The patient should not suffer from cognitive disorders at the same time - which cause learning disorders. (It is clear according to the documents of the case). Not suffering from mental retardation (it is clear according to the documents of the case) The patient should not be affected by the side effects of drug and non-drug treatment The patient has not experienced stressful events such as divorce and loss of loved ones during the last six months . The patient has not participated in interventions similar to the intervention of this study at the same time or recently The patient has relative and higher vision (it is clear by examining the mental status examination form recorded in the patient's file by the researcher). The patient should be able to speak Persian and be literate in reading and writing (able to complete the questionnaires). The patient and his accompanying person should have access to a smartphone and the Internet and should be familiar with the ITA messenger program, so that if they are unable to attend the third stage of the questionnaires one month after the end of the intervention, they can In this way, he communicated with them (in order to complete the questionnaire one month after the intervention, when the patient was probably discharged from the hospital). The patient does not have a recent history of substance abuse.
Exclusion criteria:
1) The unwillingness of the patient or his family to continue their presence in the study. 2) absence of more than two patient sessions from the intervention sessions 3) Return of the patient to the acute period of the disease 4) Transferring the patient to another hospital or dying during the study 5) causing any physical problem or discomfort, as a result of which the sample is no longer able to continue participating in the study.
Age
From 18 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
Generating random samples in spss statistical software: Transform; compute variables; random numbers (RV-UNIFORM(min,max)) The sampling method is based on available sampling and random allocation of samples using spss statistical software. In this way, for the samples, based on the determined sample size, we will consider numbers from 1 to 60, then with the help of spss software and according to the mentioned route, we will randomly allocate 30 people in each of the test and control 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
Ethics Committee in Research Faculty of Nursing, Management and Rehabilitation - Isfahan University
Street address
Isfahan University of Medical Sciences ,Isfahan ,Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.170

Health conditions studied

1

Description of health condition studied
depressive disorders
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

2

Description of health condition studied
bipolar disorders
ICD-10 code
F31
ICD-10 code description
Bipolar disorder

Primary outcomes

1

Description
The score of social skills in Riggio and Kanari social skills questionnaire
Timepoint
The beginning of the study (before the intervention), immediately after and one month after the educational program
Method of measurement
Riggio and Kanari social skills questionnaire

2

Description
Perceived social stigma score from the Michael King Stigma Questionnaire
Timepoint
The beginning of the study (before the intervention), immediately after and one month after the educational program
Method of measurement
Michael King Stigma Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The sessions of the emotion regulation program will be conducted by the researcher in groups of 8-10 patients three times in the classroom of Khurshid and Farabi Hospital in Isfahan in 6 sessions of 30-45 minutes. The content of these sessions is based on a training booklet that provides the patients with a summary of the discussed training in the form of a training booklet. In addition, the educational content of the sessions will be transmitted through group discussions, lectures, questions and answers, and presentation of videos and slides.
Category
Other

2

Description
Control group: They do not receive any educational program and only participate in two sessions of introduction and discussion.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi hospital
Full name of responsible person
Atefe Azimi
Street address
Farabi Specialized and Subspecialized Hospital, Arghwaniye Blvd., Mushtaq 3rd St., Isfahann ,Iran
City
Isfahan
Province
Isfehan
Postal code
81551-13153
Phone
+98 31 3795 2000
Email
farabi@mui.ac.ir

2

Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Atefe Azimi
Street address
khorshid medical educational research complex ,Governorate Street ,Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81458-33117
Phone
+98 31 3222 2127
Email
Nour@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Nursing and Midwifery Faculty., Isfahan University of Medical Sciences., Hezerjerib Ave
City
isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@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
Atefe Azimi
Position
Master's student in psychiatry
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezarjerib Ave., Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Email
atefe.azimi.nk76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefe Azimi
Position
Master's student in psychiatry
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7565
Email
atefe.azimi.nk76@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sima Ghezelbash
Position
Faculty member- instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Isfahan University Of Medical Sciences, Hezar-Jerib Ave., Isfahan, IR Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7565
Email
ghezelbash@nm.mui.ac.ir

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
Not applicable
Data Dictionary
Not applicable
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