Protocol summary

Summary
(1) Objectives: The aim of this study is to determine the effect of group psychoeducational program on attitude toward mental illness in families of patients with schizophrenia and bipolar disorders. (2) Design: This research is a randomized clinical trial study(3) Setting and conduct: The sample size of this study has been estimated 80 families for schizophrenic patients group with 40 persons in control group and 40 persons in experimental group allocated randomly and 74 families for bipolar patients group with 37 families in control group and 37 families in experimental group allocated randomly. The data for this study will be gathered through Opinion about mental illnesses questionnaire. (4) Participants inclusion criteria: having willingness to participate in the study, literacy, being main caregiver of and responsible for patients with bipolar and schizophrenia disorders, not having a major psychiatric problem. (5) Intervention: First, the pretest will be done in both groups. The families of experimental group will receive 9 continuous 90-minutes psychoeducational sessions but the control group will not receive any intervention. Finally, the posttest will be done for both groups and the results will be compared. (6) The main outcome variable: Improving the attitude of familes toward mental illness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509238359N2
Registration date: 2015-10-02, 1394/07/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-02, 1394/07/10
Registrant information
Name
Farnaz Rrahmani
Name of organization / entity
Tabriz nursing and midwifery school
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
frahmani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of psychiatry and behavioral sciences, Tabriz University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2014-09-23, 1393/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group psychoeducational programme on attitude toward mental illness in families of patients with schizophrenia and bipolar disorders: a randomized clinical trial
Public title
Effect of psychoeducation on attitude towards mental illness in families of patients with bipolar and schizopherenia disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having willingness to participate in the study; Being main caregiver of and responsible for patients with bipolar and schizophrenia disorders; Not having a major psychiatric problem; Literacy. Exclusion criteria: Not having willingness to participate in the study; Having physical or mental disorder that hinder the person’s presence in the psychoeducation sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random assignment of subjects into two groups: First, subjects' names will be written on paper and will be read randomly, then the subjects will be randomly divided into two groups of experimental and control.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences, Vice chancellor for research
Street address
Third floor, central building- No 2 of Tabriz University of Medical Sciences, vice chancellor for research, Golgasht street, Tabriz, Iran.
City
Tabriz
Postal code
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
96162

Health conditions studied

1

Description of health condition studied
Attitude toward mental illness
ICD-10 code
Z63.7
ICD-10 code description
Other stressful life events affecting family and household

Primary outcomes

1

Description
Attitude toward mental illness
Timepoint
Before intervention and after intervention
Method of measurement
Opinion about mental illnesses questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, the pretest will be done. The experimental group will participate in 9 sessions of psychoeducation managed by the researcher. During the sessions, the researcher will try to improve the attitude of the families toward the mental illness. Then, the posttest will be done and the results of the pretest and the posttest will be compared.
Category
Other

2

Description
Control group: This group will not receive any intervention. First, the pretest will be done. After completion of psychoeducation sessions for experimental group, the difference between pretest and posttest will be measured and compared with each other.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital of Tabriz
Full name of responsible person
Farnaz Rahmani
Street address
Elgholi street, Razi hospital of Tabriz, Tabriz, Iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Fakhari Dehkharghani
Street address
Research Center of clinical psychiatric, Eduacation unit, Elgholi street, Razi hospital of Tabriz, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Farnaz Rahmani
Position
PhD student in nursing
Other areas of specialty/work
Street address
Elgoli street, Tabriz Razi Hospital, Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 413804486
Fax
Email
farnazrahmani58@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
Farnaz Rahmani
Position
PhD student in nursing
Other areas of specialty/work
Street address
Elgoli street, Tabriz Razi Hospital, Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41333804486
Fax
Email
farnazrahmani58@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Farnaz Rahmani
Position
PhD student in nursing
Other areas of specialty/work
Street address
Elgoli street, Tabriz Razi Hospital, Tabriz, Iran.
City
Tabriz
Postal code
Phone
00
Fax
Email
fsrnazrahmani58@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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