Protocol summary

Study aim
the effectiveness of a community Re-entry program on quality of life and social functioning in people with schizophrenia.
Design
The present study is a quasi-experimental study with pre-test and post-test design which was performed on all schizophrenia patients admitted to rehabilitation centers in Tehran. For this purpose, 40 patients with schizophrenia admitted to Tolue Rehabilitation Center were selected by convenience sampling and were randomly assigned to experimental (n = 20) and control (n = 20) groups. At the beginning of the study, the two groups were matched for age and education variables.
Settings and conduct
The research group was trained by the researcher for two months, two sessions per week for 45 minutes in each session and a total of 16 sessions in the Tolue Rehabilitation Center. The control group continued their usual treatment
Participants/Inclusion and exclusion criteria
Inclusion criteria included psychiatrist's confirmation of diagnosis of schizophrenia with DSM 5 diagnostic criteria, at least two years after onset of illness, history of recurrence of symptoms, psychotic attacks and hospitalization, willingness to participate in research, ability to learn, and appropriate responses to explanations. It will be given.
Intervention groups
Experimental group received two sessions per week for a total of 16 sessions per week for 2 months
Main outcome variables
quality of life, social functioning

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190924044864N1
Registration date: 2019-10-23, 1398/08/01
Registration timing: retrospective

Last update: 2019-10-23, 1398/08/01
Update count: 0
Registration date
2019-10-23, 1398/08/01
Registrant information
Name
Zohreh Parsamoein
Name of organization / entity
The university of science and research of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 4473 7015
Email address
zohrep@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-31, 1397/08/09
Expected recruitment end date
2018-11-05, 1397/08/14
Actual recruitment start date
2018-11-10, 1397/08/19
Actual recruitment end date
2019-01-09, 1397/10/19
Trial completion date
2019-01-09, 1397/10/19
Scientific title
The Effect of Community Re-entry Program on Quality of Life and Social functioning in People with Schizophrenia
Public title
The Effect of Community Re-entry Program on Quality of Life and Social functioning in People with Schizophrenia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The psychiatrist confirmed the diagnosis of schizophrenia with DSM 5 diagnostic criteria at least two years after the onset of the disease a history of recurrence of symptoms, psychotic attacks and hospitalization ability to learn, and appropriate responses to the explanations. willingness to participate in research Participants must be men
Exclusion criteria:
Any psychiatric disorder other than schizophrenia The acute phase of the disease The presence of deafness and blindness and sensory disorders that cannot be remedied by the means. Get electric shock in the last 6 months Unwillingness to continue the evaluation Being a woman
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Forty patients admitted to Tolue Rehabilitation Center who met the inclusion criteria were selected by convenience sampling and were randomly(balloting) assigned to experimental (n = 20) and control (n = 20) groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
This study investigates the effectiveness of rehabilitation programs on the prevention of psychiatric relapse in patients with schizophrenia and the management of treatment by patients themselves.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran Azad University of Science and Research
Street address
Shohada Hesarak Boulevard, University Square, Shahid Sattari Highw,Science and Research Branch, Islamic Azad University ,Tehran
City
Tehran
Province
Tehran
Postal code
1498753634
Approval date
2018-10-30, 1397/08/08
Ethics committee reference number
دانشگاه آزاد واحد علوم وتحقیقات تهرانIR.IAU.SRB.REC.1397.073

Health conditions studied

1

Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Score of quality of life
Timepoint
after intervention
Method of measurement
SF36 questionnaire

2

Description
Score of social functioning
Timepoint
after intervention
Method of measurement
Assessment of communication and intraction Skill

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: trained for 2 months, two sessions per week for a total of 16 sessions, as follows.1- Introducing a community-based return program - 2 symptoms of disabling mental disorders - 3 discharge readiness - 4 return planning Community - 5 Community Relationships - 6 Community Stress Relief - 7 Planning a Daily Schedule - 8 Scheduling and Performing - 9 How Medication Prevents Recurrence10 - Evaluating the Effect of Prescription Drugs - 11 Solving Medication Problems - 12 Problem Solving Problems - 13 Identifying Recurrent Alert Signs - 14 Maintaining Alert Symptoms - 15 Emergency Plan Advancement - 16 Plan Yourself Take them inside the community, they were trained.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tolue Rehabilitation Center
Full name of responsible person
Zohreh Parsamoein
Street address
No. 11, Kuhestan settlement,Blouck D1,After Entezami Science univercity,End of west hemmat,Tehran Town
City
Tehran
Province
Tehran
Postal code
1498753634
Phone
+98 21 4473 7015
Email
zohrep@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ahmad Tajabadi
Street address
End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University - Science and Research Branch
City
Tehran
Province
Tehran
Postal code
1477893855-
Phone
+98 21 4486 5154
Fax
+98 21 4486 5167
Email
zohrep@yahoo.com
Web page address
http://sapp.ir/srbnewss
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
1
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
ZohrehParsamoein
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 11, Kuhestan settlement,Blouck D1,After Entezami Science univercity,End of west hemmat,Tehran Town
City
Tehran
Province
Tehran
Postal code
1498753634
Phone
+98 21 4473 7015
Email
zohrep@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Parsamoein
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 11, Kuhestan settlement,Blouck D1,After Entezami Science univercity,End of west hemmat,Tehran Town
City
Tehran
Province
Tehran
Postal code
1498753634
Phone
+98 21 4473 7015
Email
zohrep@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zohreh Parsamoein
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 11, Kuhestan settlement,Blouck D1,After Entezami Science univercity,End of west hemmat,Tehran Town
City
Tehran
Province
Tehran
Postal code
1498753634
Phone
+98 21 4473 7015
Email
zohrep@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data obtained from the results are shared
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
All people
Under which criteria data/document could be used
Email the author if you do similar research to access data and questionnaires.
From where data/document is obtainable
ZohrehParsamoein-09126850844
What processes are involved for a request to access data/document
After the e-mail is sent to the author, the required information is sent to the recipient for three days
Comments
All information is fully provided.
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