The effect of cognitive-behavioral group training of self-care Skills on positive, negative symptoms, general psychopathology and self-care in patients with schizophrenia
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, 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.
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
Acronym
IRCT registration information
IRCT registration number:IRCT20180817040818N2
Registration date:2020-08-23, 1399/06/02
Registration timing:registered_while_recruiting
Last update:2020-08-23, 1399/06/02
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
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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:
54
Randomization (investigator's opinion)
Randomized
Randomization description
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.
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 three months after intervention
Method of measurement
Positive and Negative Clinical Syndrome Scale (PANSS)
2
Description
Self- care
Timepoint
Before intervention, after intervention and three 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
Islamic Azad University Torbat-e Jam branch
Full name of responsible person
Mohammad Hossein Bayazi
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.