-Aim of study:
Effect of psycho-education on internalized stigma of clients with bipolar disorder.
-Method of study:
This is a Non-randomized controlled clinical trial.
Inclusion criteria: suffering from bipolar disorder type one or two according to medical records; participants aged 18 to 60 years.
Exclusion criteria: Suffering from cognitive disorder such as Alzheimer's.
This study will be carried out among 84 patients with bipolar disorder type one or two. Equal number of volunteers from both gender will be entered to the trial .
Method: Participants of this study are patients with bipolar disorder who are hospitalized in Iran Psychiatry Hospital. Participants will be selected based on inclusion criteria. Psycho-educational program for client will be held in group of 5 to 8 members, during six session 60 minute (three times a week). The control group will be received only routine interventions. The inventory for Internalized Stigma of Mental Illness (ISMI) will be used in this study. the questionnaire will be completed by both groups before the start of intervention (pre-test) and three weeks after start of intervention (post-test).
The time required for full implementation is 12 months.
Project outcomes: Internalized stigma of client with bipolar disorder.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016060923683N3
Registration date:2017-02-10, 1395/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Naiemeh Seyedfatemi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 1880
Email address
seyedfatemi.n@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences,School of Nursing and Midwifery
Expected recruitment start date
2016-09-18, 1395/06/28
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of psycho-education program on internalized stigma in
clients with bipolar disorder
Public title
Effect of psycho-education on stigma in clients with bipolar disorder
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
suffering from bipolar disorder type one or two according to medical records; being hospitalized for at least one week; participants aged 18 to 60 years; the ability to participate in the group;
Exclusion criteria:
Suffering from cognitive disorder such as Alzheimer's.
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:
84
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences Ethics Committee
Street address
Hemmat Highway, Tehran
City
Tehran
Postal code
Approval date
2016-06-06, 1395/03/17
Ethics committee reference number
IR.IUMS.REC. 1395.9311688006
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
2
Description of health condition studied
Bipolar disorder
ICD-10 code
F30
ICD-10 code description
Manic episode
Primary outcomes
1
Description
Internalized Stigma
Timepoint
Before and three weeks after intervention
Method of measurement
Internalized Stigma of Mental Illness (ISMI) scale
Secondary outcomes
empty
Intervention groups
1
Description
Psycho-educational program for client will be held in group of 5 to 8 members during six session 60 minute, three times a week. Each session will be started with a summary of the previous session, and the main topic will be thought, at the end of the each session the main points will be reviewed and clients' questions will be answered.
Category
Other
2
Description
The control group will be received only ward routine interventions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Nahid Akbari
Street address
School of Nursing and Midwifery-Rasheed Yassami Street-Tehran
City
Tehran
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, School of Nursing and Midwifery
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
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Zinat Keshavarz
Position
Masters student
Other areas of specialty/work
Street address
School of Nursing and Midwifery-Rasheed Yassami Street-Tehran
City
Tehran
Postal code
Phone
+98 288882886
Fax
Email
keshavrzz64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences, School of Nursing and Midwifery
Full name of responsible person
Naime Seyedfatemi
Position
Professor
Other areas of specialty/work
Street address
School of Nursing and Midwifery-Rasheed Yassami Street-Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2886
Fax
Email
nseyedfatemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences-School of Nursing and Midwifery
Full name of responsible person
Zinat Keshavarz
Position
Masters student
Other areas of specialty/work
Street address
School of Nursing and Midwifery-Rasheed Yassami Street-Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
keshavarzz64@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)