Comparative study of role of "current" and "need assessment based" family education of schizophrenic patients on recurrence of shizophrenia, patients performance and quality of life and family members, quality of life. A controlled study
Family psycho-education is one of the most effective interventions for preventing relapse in patients with schizophrenia. We are going to evaluate the efficacy of a needs-assessment based educational program and compared it with a current program in the treatment of schizophrenia.
Patients with schizophrenia and their families (n = 60) are going to allocated to needs-assessment based education (treatment) and current education (control) programs; both will include 10 sessions of education within about six months. Symptoms will be assessed by the Positive and Negative Syndrome Scale (PANSS) ,GAF, WHO-QOL-Brief, SQLS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303172266N3
Registration date:2013-05-15, 1392/02/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-15, 1392/02/25
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2013-02-20, 1391/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of role of "current" and "need assessment based" family education of schizophrenic patients on recurrence of shizophrenia, patients performance and quality of life and family members, quality of life. A controlled study
Public title
Role of need assessment based family education of schizophrenic patients on recurrence of shizophrenia, patients performance and quality of life and family members, quality of life.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterion: patients with schizophrenia, diagnosed based on DSM-IV-TR Criteria and their families.
Exclusion criteria: patients with debilitating diseases such as uncontrolled epilepsy and mental retardation and those who were addicted to any substance, drug, or alcohol were not included into the study. Also, those who had received psycho-education or family therapy during the past two years.
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
The study was approved by the and all participants signed an informed consent
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
184145
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
The primary outcome of the study was improvement in symptoms severity
Timepoint
Every 3 months for 18 months
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
1
Description
Global function of the patients
Timepoint
Baseline and then every 6 months for 18 months.
Method of measurement
Global assessment of function index(GAS0
2
Description
Patients’ quality of life
Timepoint
Baseline and then every 6 months for 18 months.
Method of measurement
Schizophrenia Quality of Life Scale
3
Description
Quality of life of families
Timepoint
Baseline and then every 6 months for 18 months.
Method of measurement
World Health Organization Quality of Life Questionnaire-Short Form
Intervention groups
1
Description
Those in the control group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?.Educators of the control group will be mental health nurses who are working for the clinic and will unaware that some of their participants are under observation by the study.
Category
Treatment - Drugs
2
Description
Those in the study group will receive psycho-education based on the current protocols. Number of the sessions (10 sessions with 15 days intervals) and the structure were similar for the two groups (Atkinson and Coia).The subjects for education include 1) What do you know of schizophrenia?, 2) What is schizophrenia?, 3) What causes schizophrenia?, 4) Different methods of treatment for schizophrenia, 5) Problems of patient’s family, 6) Family and Schizophrenia (learning ways to deal with stress), 7) Creating an environment with minimal stress (coping skills), 8) How to manage and control the chaotic behavior of the patient, 9) Use of services and deal with crises, and 10) Where are we and where are we going?. Educators of the study group will be two residents of psychiatry educated with family education based on need assessment program.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor hospital
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr Peiman Adibi
Street address
School of Medicine, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan Universit
Full name of responsible person
Gholam Reza Kheirabadi
Position
Assistant Prof. of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Postal code
Phone
+98 31 1222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan Universit
Full name of responsible person
Golam Reza Kheirabadi
Position
Assistant Prof. of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Postal code
اصفهان
Phone
+98 31 1222 2135
Fax
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Behavioral Sciences Research Center, Department of Psychiatry, school of medicine, Isfahan University of Medical Sciences, Isfahan, IRAN
City
Isfahan
Postal code
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)