Determining the effect of Lieberman's return program on reducing the positive and negative symptoms and improving social skills in people with schizophrenia
Design
Two arm parallel group randomised trial without blinded groups
Settings and conduct
This is an experimental study that will be conducted in 2017 at Khorshid hospital in Isfahan. The target population of the study is patients with schizophrenia who are under the care and treatment programs at the center.
Participants/Inclusion and exclusion criteria
A) inclusion criteria:
• Patients with schizophrenia
• Patient agrees to participate in the study
• aged 18-60 years
• Ability to read and write
• Lack of mental retardation
B-exclusion criteria:
• Cancellation of the patient's presence in the study
• Lack of participation in more than 3 sessions of the Lemberman's Community Return Program
Intervention groups
Patients in the first group are under the training of a return to the Lieberman community, and the second group, which is considered as the control group, continues to treat its usual treatment as a drug therapy. The groups are selected before and after the study using the Matsun social skills scale and the scale of assessment of positive and negative symptoms.
Main outcome variables
All patients were subjected to pretest and immediately and 3 months after intervention by using the Matsun social skills inventory and the negative and positive symptom scales. The changes in social skills score and positive and negative symptoms within each group and It is compared between the two groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N10
Registration date:2019-01-16, 1397/10/26
Registration timing:prospective
Last update:2019-01-16, 1397/10/26
Update count:0
Registration date
2019-01-16, 1397/10/26
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
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of the community reentry program on the positive and negative symptoms and improving the social skills of schizophrenic patients
Public title
The Effectiveness of the community reentry program on the positive and negative symptoms and improving the social skills of schizophrenic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Schizophrenic patients
Patient agreement for study inclusion
Aged 18-60
Lack of mental retardation
Ability to read and write
Exclusion criteria:
Refuse of the patient from continuing the study
Lack of participation in more than 3 sessions of the Lieberman's return to community program
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avey, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2019-01-11, 1397/10/21
Ethics committee reference number
IR.MUI.MED.REC.1397.080
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20.9
ICD-10 code description
Schizophrenia, unspecified
Primary outcomes
1
Description
The changes in social skills score and positive and negative symptoms within each group and It is compared between two groups.
Timepoint
Before, just after and three month after training
Method of measurement
Matson's Social Skills Questionnaire and Positive and Negative Symptom Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Schizophrenic patients who will train the Lieberman's return to community community program
Category
Lifestyle
2
Description
Control group: This group of schizophrenic patients will not be train
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Gholam Reza Kheirabadi
Street address
Behavioral Sciences Resaerch Center, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3792 3071
Fax
+98 31 3792 3071
Email
Info@ui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Kheirabadi
Street address
Vice chancellor for research, Isfahan University of Medical Sciences; Faculty of Medicine; Isfahan University of Medical Sciences; Hezar-Jarib Street; Isfahan; Iran
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2038
Email
Info@ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Kheirabadi
Position
Psychiatrist/ Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Khorshid hospital
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabad@bsrc.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8145831451
Phone
+98 31 1222 2135
Fax
+98 31 1222 2135
Email
kheirabadi@bsrc.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Reza Kheirabadi
Position
Assistant Professor of Psychiatry
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Behavioral Sciences Research Center, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8145831451
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)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total data of the participants will be available after being unidentifiable.
When the data will become available and for how long
Start of access immediately after publication
To whom data/document is available
All researchers who need this data
Under which criteria data/document could be used
All type of analysis are allowed and for receiving data you have to send Email to scientific person of this syudy
From where data/document is obtainable
Email: kheirabadi@bsrc.mui.ac.ir and phone number 00989131086637
What processes are involved for a request to access data/document
It does not require any special work and it is quickly available