Effect of Psycho education on performance and depression and anxiety of family with schizophrenia patients
Design
Study is done as clinical trial on the family with schizophrenia patients and hospitalized in 22 Bahman hospital of Qazvin, in the recent 6 months.
Settings and conduct
The aim of this study is to evaluate the Effect of Psycho education on performance and depression and anxiety of family with schizophrenia patients. Study is done as clinical trial on the family with schizophrenia patients and hospitalized in 22 Bahman hospital of Qazvin, in the recent 6 months. Inclusion criteria are an age from 20-60 year old, a member of family with bipolar disorder diagnosed by psychologist, same condition of disease severity. In the case of dissatisfaction, Family is excluded of study. At first, all families are attended to a general session to justify the outline of method, and also to fill a consent form and questionnaire. Then they are educated weekly through an educational set for two sessions in 2 hours. The educational sessions are present as free by psychologist researcher in a conference room at the same hospital. After 6 months of intervention, families are invited to fill the questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a member of family with schizophrenia diagnosed by psychologist, trusty patients' caregiver, family or caregiver without disease symptoms, family with hospitalized patients in a recent 6 months in center, patients with same condition of disease severity and in age from 20-60 year old.
Exclusion criteria: contributed caregivers with psychiatric disease, and family with dissatisfaction.
Intervention groups
family of schizophrenia patients
Main outcome variables
The Rate of trainee performance
The Rate of trainee anxiety
The Rate of trainee depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038835N1
Registration date:2018-03-31, 1397/01/11
Registration timing:retrospective
Last update:2018-03-31, 1397/01/11
Update count:0
Registration date
2018-03-31, 1397/01/11
Registrant information
Name
Zahra Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5978
Email address
z.hashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-27, 1396/07/05
Expected recruitment end date
2018-03-25, 1397/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Psycho education on performance and depression and anxiety of family with Schizophrenia patients
Public title
Effect of Psycho education on performance and depression and anxiety of family with Schizophrenic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A member of family with schizophrenia diagnosed by Psychologist
Trusty patients' caregiver
Family or caregiver without disease symptoms
Family with hospitalized patients in a recent 6 months in center
Patients with same condition of disease severity
Age from 20-60 year old
Exclusion criteria:
Contributed caregivers with psychiatric disease
Family with dissatisfaction
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.QUMS.REC1396.260
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
The Rate of trained performance
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
The Rate of trained anxiety
Timepoint
Before and after intervention
Method of measurement
Questionnaire
2
Description
The Rate of trained depression
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Family of patients with schizophrenia
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital of Qazvin
Full name of responsible person
Dr Seyede Zahra Hashemi
Street address
22 Bahman hospital, Rah'ahan street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Valiasr street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyede Zahra Hashemi
Position
Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Valiasr street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyed Alireza Haj Seyed Javadi
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Rah'ahan street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyede Zahra Hashemi
Position
Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Rah'ahan Street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD