The effect of family members' psycho-educational intervention for on caregiver burdens and psychiatric symptoms in patients with schizophrenia in Shiraz, Iran
The objective of this study was the investigation of the effectiveness of family psychoeducation in reducing patients’ symptoms and on burden of family caregivers, and the relationship between these two aspects. A total of seventy Iranian outpatients with a diagnosis of schizophrenia disorder and their caregivers were randomly allocated into the experimental (n=35) or control groups (n=35) from Hafez and Ebnesina hospital in 2009. The patients in the experimental group received antipsychotic drug treatment and a psychoeducational program was arranged for their caregivers. The patients in the control group only received routine treatment. At the baseline, immediately post-intervention and one month later, validated tools were used to assess patients’ psychological status and caregiver’s burden.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809122812N1
Registration date:2011-07-25, 1390/05/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-07-25, 1390/05/03
Registrant information
Name
Farkhondeh Sharif
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1212 2401
Email address
fsharif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research- Shiraz University of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-12-22, 1388/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family members' psycho-educational intervention for on caregiver burdens and psychiatric symptoms in patients with schizophrenia in Shiraz, Iran
Public title
schizophrenic family members' psycho-education and its effect on patients psychiatric symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria for the patients: a diagnosis of schizophrenia disorder according to DSM-IV criteria within the preceding 5 years, lack of any comorbidity, no any other mental illnesses. All caregivers who were invited to participate identified themselves as the primary caregiver with the greatest responsibility for providing care within the family, and they themselves had not any known mental illness
Exclusion criteria: the family’s participation in another psychoeducational programs within the preceding year, caring for more than one family member with mental illness, substance abuse problem in the patient
Age
From 16 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Shiraz University of Medical Sciences
Street address
Beside red cresent organization, Zand Street,
City
Shiraz
Postal code
713451359
Approval date
2010-03-18, 1388/12/27
Ethics committee reference number
88-5007
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20, F29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
psychological symptom
Timepoint
Before and immediately and one month after intervention
Method of measurement
by psychological symptom questionnaire
2
Description
Family burden
Timepoint
before and immediately and one month after intervention
Method of measurement
family burden questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving antipsychotic drug treatment as well as psychoeducational program was held for their caregivers
Category
Rehabilitation
2
Description
Control group: routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Project cooardinator
Street address
Abiverdi Blvd,
City
Shiraz
2
Recruitment center
Name of recruitment center
Ebn Sina Hospital
Full name of responsible person
project cooardinator
Street address
Ebne-Sina Hospital, Quran Gate
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Dabbaghmanesh
Street address
Central building of Shiraz University of Medical Sciences, Zand St.,
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farkhondeh Sharif
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shiraz University of Medical Sciences
City
Shiraz
Postal code
713451359
Phone
+98 71 1647 4255
Fax
+98 71 1647 4252
Email
fsharif@sums.ac.ir
Web page address
WWW.SUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farkhondeh Sharif
Position
PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Shiraz University of Medical Sciences,
City
Shiraz
Postal code
713451359
Phone
+98 71 1647 4255
Fax
+98 71 1647 4252
Email
fsharif@sums.ac.ir
Web page address
WWW.SUMS.AC.IR
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)