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The effect of cognitive-behavioral group training of self-care Skills on positive, negative symptoms, general psychopathology and self-care in patients with schizophrenia

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History
# Registration date Revision Id
2 2021-07-26, 1400/05/04 194194
1 2020-08-23, 1399/06/02 148132
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  • Protocol summary

    In this randomized controlled clinical trial, 54 eligible patients with schizophrenia will be selected by convenience method. then, they will be assigned to two groups of intervention and control by permuted block randomization One-way blind method.
    In this randomized controlled clinical trial, 52 eligible patients with schizophrenia will be selected by convenience method. then, they will be assigned to two groups of intervention and control by permuted block randomization One-way blind method.
    در اين کارآزمايي باليني شاهد دار تصادفي شده، ابتدا 54 نفر از بیماران مبتلا به اسکيزوفرني واجد شرایط شرکت در مطالعه به روش در دسترس انتخاب خواهند شد و سپس به روش بلوک بندی تصادفی و یک سو کور به دو گروه مداخله و کنترل تخصيص داده خواهند شد.
    در اين کارآزمايي باليني شاهد دار تصادفي شده، ابتدا 52 نفر از بیماران مبتلا به اسکيزوفرني واجد شرایط شرکت در مطالعه به روش در دسترس انتخاب خواهند شد و سپس به روش بلوک بندی تصادفی و یک سو کور به دو گروه مداخله و کنترل تخصيص داده خواهند شد.

  • General information

    54
    52
    empty
    50
    2020-09-22, 1399/07/01
    2020-10-11, 1399/07/20
    empty
    2020-07-22, 1399/05/01
    empty
    2020-10-31, 1399/08/10
    empty
    2021-05-20, 1400/02/30
    empty
    Correction of sample size and completion date of sampling
    empty
    اصلاح حجم نمونه و تاريخ اتمام نمونه گيري
    Sampling will be perform by permuted block randomization One-way blind method. Eligible patients will be selected by the convenience method and will be divided into two groups A and B by a researcher who is blind to the study conditions. Then, 12 blocks of six (AAABBB, ABABAB, BABABA, BBBAAA, ABBABA, BAABBA BABAA, etc.) were determined and each of them was assigned a number between 1 and 12. Based on the table of random numbers, it was determined that the order of entry of blocks into the study and assignment of individuals to intervention and control groups.
    Sampling will be perform by permuted block randomization. Eligible patients will be selected by the convenience method and will be divided into two groups A and B by a researcher. for this purpose, 13 blocks of four (AABB, ABAB, BABA, BBAA, ABBA, BABA, etc.) were determined and each of them was assigned a number between 1 and 13. Based on the table of random numbers, it was determined that the order of entry of blocks into the study and assignment of individuals to intervention and control groups.
    نمونه گيري به روش بلوک بندي تصادفي و يک سو کور انجام خواهد گرديد. بيماران واجد شرايط به صورت در دسترس انتخاب و توسط پژوهشگري که به شرايط مطالعه کور است در دو گروه A و B قرار خواهند گرفت. سپس، 13 بلوک شش تايي (AAABBB، ABABAB، BABABA، BBBAAA، ABBABA، BAABBA BABAA و ....) تعیین و به هر کدام عددی بین 1 تا 13 اختصاص داده شد. براساس جدول اعداد تصادفی ترتیب ورود بلوک ها به مطالعه و تخصیص افراد به گروههای مداخله و کنترل تعیین گردید.
    نمونه گيري به روش بلوک بندي تصادفي انجام خواهد گرديد. بيماران واجد شرايط به صورت در دسترس انتخاب و توسط پژوهشگر در دو گروه A و B قرار خواهند گرفت. براي اين منظور، 13 بلوک چهار تايي (AABB, ABAB, BABA, BBAA, ABBA, BABA, ....) تعیین و به هر کدام عددی بین 1 تا 13 اختصاص داده شد. براساس جدول اعداد تصادفی ترتیب ورود بلوک ها به مطالعه و تخصیص افراد به گروههای مداخله و کنترل تعیین گردید.

  • Primary outcomes

    #1
    Before intervention, after intervention and three months after intervention
    Before intervention, after intervention and six months after intervention
    قبل از مداخله، پس از مداخله و سه ماه پس از مداخله
    قبل از مداخله، پس از مداخله و شش ماه پس از مداخله
    #2
    Before intervention, after intervention and three months after intervention
    Before intervention, after intervention and six months after intervention
    قبل از مداخله، پس از مداخله و سه ماه پس از مداخله
    قبل از مداخله، پس از مداخله و شش ماه پس از مداخله

  • Recruitment centers

    #1
    Name of recruitment center - English: Ebn'e Sina Psychiatric Hospital
    Name of recruitment center - Persian: بيمارستان روانپزشکي ابن سينا
    Full name of responsible person - English: Mohammad Hossein bayazi
    Full name of responsible person - Persian: محمد حسين بياضي
    Street address - English: Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
    Street address - Persian: مشهد، انتهای خیابان حرعاملی، جنب نقلیه آستان قدس
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 919583134
    Phone: +98 51 3732 6767
    Fax:
    Email: bayazi123@gmail.com
    Web page address:
    Name of recruitment center - English: Ebn'e Sina psychiatric hospital
    Name of recruitment center - Persian: بيمارستان روانپزشکي ابن سينا
    Full name of responsible person - English: Mohammad Hossein Bayazi
    Full name of responsible person - Persian: محمد حسين بياضي
    Street address - English: Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
    Street address - Persian: مشهد، انتهای خیابان حرعاملی، جنب نقلیه آستان قدس
    City - English: Mashhad
    City - Persian: مشهد
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 919583134
    Phone: +98 51 3732 6767
    Fax:
    Email: Bayazi123@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Islamic Azad University Torbat-e Jam branch
    Name of organization / entity - Persian: دانشگاه آزاد اسلامي واحد تربت جام
    Full name of responsible person - English: Mohammad Hossein Bayazi
    Full name of responsible person - Persian: محمد حسين بياضي
    Street address - English: Campus of Islamic Azad University Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
    Street address - Persian: تربت جام، کیلومتر 5 جاده فریمان، پردیس دانشگاه آزاد اسلامی واحد تربت جام
    City - English: Torbat-e Jam
    City - Persian: تربت جام
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9576174814
    Phone: +98 51 5251 0220
    Fax:
    Email: mh.bayazi@iautj.ac.ir
    Web page address: http://iautj.ac.ir/index.php/en/
    contact.organization_id:
    Name of organization / entity - English: Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch
    Name of organization / entity - Persian: معاونت پژوهشي دانشگاه آزاد اسلامي واحد تربت جام
    Full name of responsible person - English: Sayyed Mehdi Sadat
    Full name of responsible person - Persian: سید مهدی سادات
    Street address - English: Campus of Islamic Azad university Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
    Street address - Persian: تربت جام، کیلومتر 5 جاده فریمان، پردیس دانشگاه آزاد اسلامی واحد تربت جام
    City - English: Torbat-e Jam
    City - Persian: تربت جام
    Province: Razavi Khorasan
    Country: Iran (Islamic Republic of)
    Postal code: 9576174814
    Phone: +98 51 5251 0220
    Fax:
    Email: mh.bayazi@iautj.ac.ir
    Web page address: http://iautj.ac.ir/index.php/en/

Protocol summary

Study aim
Determining the effect of cognitive-behavioral group training of self-care skills on positive, negative, general psychopathology symptoms and self-care in patients with schizophrenia
Design
In this randomized controlled clinical trial, 52 eligible patients with schizophrenia will be selected by convenience method. then, they will be assigned to two groups of intervention and control by permuted block randomization One-way blind method.
Settings and conduct
This study was performed in Ebn'e Sina Psychiatric Hospital in Mashhad. Patients with schizophrenia were invited to enter the study after obtaining written consent from their guardian. Then, by permuted block randomization one-way blind method, they were assigned to the intervention and control groups by a researcher who was blind to the study conditions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A minimum of six months and a maximum of three years have elapsed since the diagnosis of schizophrenia History of at least one previous hospitalization Achieve a score above 50 on the Positive and Negative Clinical Syndrome Scale (PANSS) Having verbal ability, education of 8 grades or more No change in standard antipsychotic dose in the last 3 months Exclusion criteria: History of substance and alcohol abuse Physical involvement with group members and therapists before initiating therapeutic interventions Conflict with legal issues
Intervention groups
Intervention group will receive cognitive behavioral group training with self-care skills content by challenging cognitive errors related to self-care skills during 10 one-and-a-half hour sessions. Control group will receive the routine care.
Main outcome variables
Positive, negative symptoms and general psychopathology, self-care

General information

Reason for update
Correction of sample size and completion date of sampling
Acronym
IRCT registration information
IRCT registration number: IRCT20180817040818N2
Registration date: 2020-08-23, 1399/06/02
Registration timing: registered_while_recruiting

Last update: 2021-08-16, 1400/05/25
Update count: 1
Registration date
2020-08-23, 1399/06/02
Registrant information
Name
Masoud Kashani Lotfabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2701
Email address
kashanim1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-19, 1399/04/29
Expected recruitment end date
2020-10-11, 1399/07/20
Actual recruitment start date
2020-07-22, 1399/05/01
Actual recruitment end date
2020-10-31, 1399/08/10
Trial completion date
2021-05-20, 1400/02/30
Scientific title
The effect of cognitive-behavioral group training of self-care Skills on positive, negative symptoms, general psychopathology and self-care in patients with schizophrenia
Public title
The Effect of Cognitive-Behavioral Group Training of Self-Care Skills on Positive, Negative Symptoms, General psychopathology and Self-Care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A minimum of six months and a maximum of three years have elapsed since the diagnosis of schizophrenia History of at least one previous hospitalization Achieve a score above 50 on the Positive and Negative Clinical Syndrome Scale (PANSS) Having verbal ability, education of 8 grades or more No change in standard antipsychotic dose in the last 3 months
Exclusion criteria:
History of substance and alcohol abuse Physical involvement with group members and therapists before initiating therapeutic interventions Conflict with legal issues
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 52
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be perform by permuted block randomization. Eligible patients will be selected by the convenience method and will be divided into two groups A and B by a researcher. for this purpose, 13 blocks of four (AABB, ABAB, BABA, BBAA, ABBA, BABA, etc.) were determined and each of them was assigned a number between 1 and 13. Based on the table of random numbers, it was determined that the order of entry of blocks into the study and assignment of individuals to intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who performs the study statistics will be blind to the study conditions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad university Torbat-e Jam branch
Street address
Campus of Islamic Azad University of Torbat-e Jam, 5 km of Freeman road, Torbat-e-Jam
City
Torbat-e Jam
Province
Razavi Khorasan
Postal code
9576174814
Approval date
2020-07-18, 1399/04/28
Ethics committee reference number
IR.IAU.TJ.REC.1399.007

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
Positive, negative symptoms and general psychopathology
Timepoint
Before intervention, after intervention and six months after intervention
Method of measurement
Positive and Negative Clinical Syndrome Scale (PANSS)

2

Description
Self- care
Timepoint
Before intervention, after intervention and six months after intervention
Method of measurement
Self-Care Needs Scale (SCRS-H)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: They will receive cognitive behavioral group training with self-care skills content by challenging cognitive errors related to self-care skills during 10 one-and-a-half hour sessions.
Category
Rehabilitation

2

Description
Control group: They will receive the routine care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebn'e Sina psychiatric hospital
Full name of responsible person
Mohammad Hossein Bayazi
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3732 6767
Email
Bayazi123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch
Full name of responsible person
Sayyed Mehdi Sadat
Street address
Campus of Islamic Azad university Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
City
Torbat-e Jam
Province
Razavi Khorasan
Postal code
9576174814
Phone
+98 51 5251 0220
Fax
Email
mh.bayazi@iautj.ac.ir
Web page address
http://iautj.ac.ir/index.php/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch
Proportion provided by this source
100
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 Torbat-e Jam branch
Full name of responsible person
Masoud Kashani Lotfabadi
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Campus of Islamic Azad university Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
City
Torbat-e Jam
Province
Razavi Khorasan
Postal code
9576174814
Phone
0098515282210222
Fax
Email
Kashanim1@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Torbat-e Jam branch
Full name of responsible person
Masoud Kashani Lotfabadi
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Campus of Islamic Azad University Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
City
Torbat-e Jam
Province
Razavi Khorasan
Postal code
9576174814
Phone
+985282210222
Email
Kashanim1@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Torbat-e Jam branch
Full name of responsible person
Masoud Kashani Lotfabadi
Position
PhD student in psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Campus of Islamic Azad University Torbat-e Jam branch, 5 km of Freeman road, Torbat-e Jam
City
Torbat-e Jam
Province
Razavi Khorasan
Postal code
9576174814
Phone
+985282210222
Email
Kashanim1@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Clinical outcomes of the study will be published in the form of a paper
When the data will become available and for how long
The results of the study will be published after data collection over the next 6 months
To whom data/document is available
Data documents will be shared in thesis and article form.
Under which criteria data/document could be used
Islamic Azad university Torbat-e Jam branch license will only be available to researchers working in academic institutions
From where data/document is obtainable
Islamic Azad university Torbat-e Jam branch license will only be available to researchers working in academic institutions
What processes are involved for a request to access data/document
It should be done through the research vice chancellor of Islamic Azad university Torbat-e Jam branch.
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