Protocol summary

Study aim
1) Determine the effectiveness of the community return program on the therapeutic components of schizophrenia patients. The therapeutic components of this study are: Awareness of the nature of disease and drug information, readiness for discharge, ability to plan daily, quality of life, adhesion, frequency of PRN, frequency of physical inhibition, positive and negative syndrome, disability, stigma and duration Hospitalization 2) Comparison of the effectiveness of the return program to the community on the above-mentioned therapeutic outcomes, with the effectiveness of conventional psychiatric treatment in Razi Psychoanalytic Center.
Design
In this study, 80 schizophrenic patients admitted to the Razi Psychiatric Center were randomly assigned to experimental and control groups and assigned a code to each participant to hide the intervention group
Settings and conduct
This study is carried out in the inpatients units of the Raazi Psychiatric Center, in which the principles of double-blindedness are implemented. In order to ensure that double-blinded principles are implemented, the implementation and scoring of research tools and all measures , the implementation of tools and conducting interviews and other evaluation and measures in the experimental and control groups are carried out by neutral evaluators, Who are unaware of the implementation of therapeutic intervention in the experimental group and the group (trial or control) in which the patients are assigned. The intervention in the experimental group will be provided by trained instructors who will be unaware of the experimental or control assignment of the participants undergoing training. Meanwhile, subjects are unaware of being present in the experimental, or in the control group. Researcher (investigator) will score tools after implementation and interpret the findings of other measurement and evaluation methods used in this research. In order to prevent the bias in scoring tools and interpreting the results, the situation is provided so that a person is completely unaware of the logic of the present research and its evaluations, receiving the tools completed and the results of the interviews and evaluations from evaluators along with a list of patients and their belonging to test groups and controls and Deliver them to the researcher. The same person, after scoring tools and interpreting the results of the interviews and other evaluations performed, is responsible for communicating data with the patients in the experimental and control groups to prepare them for statistical analysis.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Diagnosis of schizophrenia based on medical records 2) at least a prior hospitalization and passing two years from onset 3) Age range between 22-60 years 4) tolerance for group discipline and inclination for group activity 5) Having family Exclusion criteria: 1) Comorbidity with personality and substance related and addictive disorders 2) Having self management skills
Intervention groups
This study consists of an intervention group and a control group that participants in the intervention group are in addition to conventional psychiatric treatment subject to a community re-entry program, while the control group participants receive only conventional psychiatric treatment
Main outcome variables
Increasing awareness about the nature of disease and drug information, readiness for discharge, the ability to design a daily plan, and quality of life Decreased adhesion, PRN frequency, frequency of physical inhibition, positive and negative syndrome, disability, stigma and hospitalization time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180103038207N1
Registration date: 2018-03-04, 1396/12/13
Registration timing: registered_while_recruiting

Last update: 2018-03-04, 1396/12/13
Update count: 0
Registration date
2018-03-04, 1396/12/13
Registrant information
Name
Davood Arab Ghahestany
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3341 6084
Email address
psychosis@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-18, 1396/11/29
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Community Re-entry Program On Therapeutic Outcomes in Raazi Psychiatric Center Hospitalized Schizophrenic Patients, in Comparison with Conventional Psychiatric Treatment
Public title
The Effectiveness of Community Re-entry Program (CRP) in Treatment of Schizophrenia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on medical records Age range between 22-60 years Having family Tolerance for group disciplines and inclination for group activities At least a prior hospitalization and passing two years from onset
Exclusion criteria:
Comorbidity with personality substance related and addictive disorders Having self management skills
Age
From 22 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
When the names of the patients who were selected in full-scale and according to the inclusion and exclusion criteria from hospitalized patients in the non-educational acute units of Razi Educational Medical Psychiatric Hospital reached number 10, they are listed and grouped in even and odd number according to their order in list. Then the even and odd names are assigned in the subject and control groups based on throwing the coin (tap or line), so that the first throw is done for the odd names and the tap event are assigned to experimental group and the line event in the control group. . By randomly assigning the odd persons in the list according to this method, the assignment group of even names is determined by itself and in a random fashion.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is carried out in the inpatients units of the Raazi Psychiatric Center, in which the principles of double-blindedness are implemented. In order to ensure that double-blinded principles are implemented, the implementation and scoring of research tools and all measures , the implementation of tools and conducting interviews and other evaluation and measures in the experimental and control groups are carried out by neutral evaluators, Who are unaware of the implementation of therapeutic intervention in the experimental group and the group (trial or control) in which the patients are assigned. The intervention in the experimental group will be provided by trained instructors who will be unaware of the experimental or control assignment of the participants undergoing training. Meanwhile, subjects are unaware of being present in the experimental, or in the control group. Researcher (investigator) will score tools after implementation and interpret the findings of other measurement and evaluation methods used in this research. In order to prevent the bias in scoring tools and interpreting the results, the situation is provided so that a person is completely unaware of the logic of the present research and its evaluations, receiving the tools completed and the results of the interviews and evaluations from evaluators along with a list of patients and their belonging to test groups and controls and Deliver them to the researcher. The same person, after scoring tools and interpreting the results of the interviews and other evaluations performed, is responsible for communicating data with the patients in the experimental and control groups to prepare them for statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave., daneshjo Blvd.
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.USWR.REC.1396.150

Health conditions studied

1

Description of health condition studied
Schizophrenia disorder (F25.2), Treatment and Rehabilitation
ICD-10 code
F25.2
ICD-10 code description

Primary outcomes

1

Description
Awareness of the nature of disease and drug information, and readiness for discharge
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
community re entry program test

2

Description
Ability to design a daily schedule
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
Depending on the ability to complete the daily schedule, the program returns to the community

3

Description
Quality of life
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
Short form health questionnaire

4

Description
viscosity
Timepoint
During hospitalization period
Method of measurement
Based on the number of visits to the Nursing Station

5

Description
The number of times a venous or muscular injection of psychoactive substance to calm the patient (I.e. PRN)
Timepoint
At the end of intervention
Method of measurement
View patient records documentation

6

Description
The number of fixation
Timepoint
At the end of intervention
Method of measurement
View patient records documentation

7

Description
Positive and negative syndrome
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
Positive and negative syndrome scale

8

Description
Inability
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
World Health Organization disability assessment schedule 2.0

9

Description
Stigma
Timepoint
At the beginning of the study and after the end of the intervention
Method of measurement
Stigma scale Michael King

10

Description
Duration of hospitalization
Timepoint
After inserting the discharge order in the patient file
Method of measurement
View patient records documentation

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: It consists of 40 patients who, in addition to conventional psychiatric treatment according to hospital routines, are also subject to Community Reentry Program. The program for returning to the community consists of 16 sessions of 30 to 90 minutes as follows: By default, and based on the recommendation of the author, at least 3 sessions per week are to be held for patients and the participants should not exceed 8 persons. Session 1: Introducing the Return to Community Program. Session 2: Explain the signs and symptoms of schizophrenia spectrum disorders according to the diagnosis of the participants Session 3: Determine the readiness of patients for discharge. Session 4: Planning a Community Return Program. Session 5: Communicating with Society Session 6: Coping with Stress in the Community. Session 7: Designing a Daily Program. Session 8: Exercise Rendezvous (Visit) and Do It. Session 9: How do medications prevent recurrence Session 10: Assessing the Effect of Medications. Session 11: Solving Drug Problems. Session 12: Solving Drug Side Effects. Session 13: Determine the symptoms of recurrence. Session 14: Tracking the symptoms of recurrence. Session 15: Implementing the Emergency Plan. Session 16: Bring your plan to the community. In each of these sessions, educational activities are conducted in a variety of ways, including viewing videos and asking questions about its content, internship and exterior classes, oral education through lecture and verbal interaction between trainer and patients, and role playing along with motivational components with Including scenarios related to the daily lives of patients will be made on their own initiative. Meanwhile, classroom assignments and the content of the sessions are recorded in a booklet by the patients and will be provided to the patients after the end of the session.
Category
Rehabilitation

2

Description
Control group: It consists of 40 patients who receive only routine treatment of routine psychiatric treatment and are not subject to a community reunion program.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Raazi Psychiatric Center
Full name of responsible person
Davood Arab Ghahestany
Street address
Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center
City
Rey
Province
Tehran
Postal code
1866958891
Phone
+98 21 3341 6084
Email
psychosis@uswr.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Arab, Amir Masoud, Ph. D.
Street address
kodakyar Ave., daneshjo Blvd.
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0083
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Davood Arab Ghahestany
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center
City
Rey
Province
Tehran
Postal code
1866958891
Phone
+98 21 3341 6084
Email
psychosis@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Davood Arab Ghahestany
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center
City
Rey
Province
Tehran
Postal code
1866958891
Phone
+98 21 3341 6084
Email
psychosis@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Davood Arab Ghahestany
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid rastegari Blvd., Taghi abad threeway, Moallem Sq., Raazi Psychiatric Center
City
Rey
Province
Tehran
Postal code
1866958891
Phone
+98 21 3341 6084
Email
psychosis@uswr.ac.ir

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
This item will based on the policies of recruitment center and related university
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...