(1) Objectives: The aim of this study is to examine the effect of psycho-educational group therapy on internalized stigma of family caregivers of children with Bipolar mood disorder. (2) Design: This research is an experimental study with a "pre-test, post-test and follow-up with control group" design. (3) Setting and conduct: The sample size of this study estimated 88 persons that randomly 44 persons in control group and 44 persons in experimental group will allocated. Instruments for data gathering are Demographic Questionnaire and Modified Version of Internalized Stigma Questionnaire.
(4) Participants will be chosen based on inclusion and exclusion criteria. (5) Interventions: Firstly the pre-test will be done in both groups. The experimental group will attend eight sessions of 90 minutes in psycho-educational group therapy. The control group will not receive any intervention in this duration. Then the post-test and follow up after one month will be done on both group. Finally the results of the two groups will be compared. (6) The main outcome variable: Reducing internalized stigma in receiving psycho-educational group therapy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605026834N10
Registration date:2016-12-17, 1395/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-17, 1395/09/27
Registrant information
Name
Hossein Ebrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1475 1709
Email address
ebrahimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice- Chancellor, Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-01, 1395/05/11
Expected recruitment end date
2017-02-01, 1395/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psycho-educational group therapy on internalized stigma of family caregivers of children with Bipolar mood disorder
Public title
The effect of group therapy on stigma of family of children with Bipolar mood disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Family caregiver who has not major Psychiatry problem; is first-degree relative with the patient; is the primary carer of the patient; lives in a house with the patient; has at least ability to write and read; is at least 18 and up to 60 years old; and has obtained a minimum score of 42.5 in the stigma questionnaire in pretest; the diagnosis of his/her child is confirmed by a psychiatrist based on DSM V standards; his/her child is treated as outpatient; and his child is at least 8 and up to 18 years old.
Exclusion criteria: Family caregiver has to decide to participate in other training program; dose not want to continue to participate in the study; experiences acute crisis such as divorce and death of loved one during the study; has history of substance abuse (according to self-reported); is graduated in the fields of medical sciences; has a history of serious physical illness, and known mental disorder; has absence more than one session from training sessions; his/her child hospitalized during the study; and his/her child has alcohol and drug dependency (according to the doctor or primary caregiver report).
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Sciences, Research Vice- Chancellor
Street address
Third floor, Central Building- No 2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-06-13, 1395/03/24
Ethics committee reference number
IR.TBZMED.REC.1395.268
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
F31.7
ICD-10 code description
bipolar affective disorder, currentlly in remission
Primary outcomes
1
Description
Internalized Stigmatization
Timepoint
Before, afer and one months after the intervention
Method of measurement
Internalized Stigmatization Scale of Mental Illnesses(ISSMI) Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Firstly, the pre-test will be done. Intervention group will receive 8 sessions therapy by the researcher. Then, the post-test and follow up will be done. Finally, the differences of pre-test, post-test and follow-up are compared with each other.
Category
Prevention
2
Description
Control group: This group will not receive any intervention. The differences of pre-test and post-test and follow up are measured and are compared with each other.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Dr Arash Mohaggegi
Street address
Tabriz Razi Psychiatric Hospital, Elgoli Boulevard East Azarbayjan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Vice- Chancellor, Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Third floor, No 2 Building of Tabriz University of Medical Sciences, Golgasht Ave Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Vice- Chancellor, Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somaye Janmohammadi
Position
MS in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street Tabriz
City
Tabriz
Postal code
Phone
+98 41 3475 1709
Fax
Email
Som.janmohammadi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hossein Ebrahimi
Position
PhD in nursing education
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
Phone
+98 41 3475 1709
Fax
Email
Ebrahimih@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Somayeh Janmohammadi
Position
MS in Psychiatric Nursing, Student
Other areas of specialty/work
Street address
Psychiatric Nursing Group, Tabriz Nursing and Midwifery Faculty, South Shariati Street Tabriz
City
Tabriz
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)