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General information
40
30
4030
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30
30
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2018-08-15, 1397/05/24
2018-08-15 00:00:00
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2018-11-22, 1397/09/01
2018-11-22 00:00:00
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2019-05-26, 1398/03/05
2019-05-26 00:00:00
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The word group fits into the English title
The word group fits into the English title
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جا افتادن کلمه گروه در عنوان انگليسي
جا افتادن کلمه گروه در عنوان انگليسي
The Effect of Cognitive-Behavioral Therapy on Improving Self-Care Skills
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills
The Effect of Cognitive-Behavioral Therapy on Improving Self-Care Skills in Women with Chronic Schizophrenia
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills in Women with Chronic Schizophrenia
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills in Women with Chronic Schizophrenia
Determining the effect of cognitive behavioral group therapy on improving self-care skills in women with chronic schizophrenia
Design
In this randomized clinical trial, 40 women with chronic schizophrenia were selected randomly and then randomly assigned to two groups of intervention and control
Settings and conduct
This study was conducted in Hejazi Psychiatric Hospital in Mashhad. Women with chronic schizophrenia were invited to receive a written consent from their donations if they were eligible for inclusion in the study and then randomly assigned to intervention and control groups
Participants/Inclusion and exclusion criteria
Inclusion criteria: duration of the disease recorded in the medical record was 3 years or more; having verbal ability Minimum grade 8th grade, lack of standard dose change for anti-psychotics in the past 3 months
Exclusion criteria: a history of opium and alcohol abuse; severe physical illness requires treatment; unwillingness to continue attending in therapeutic sessions; affected by epilepsy and mental retardation
Intervention groups
Cognitive-Behavioral Group Therapy with the content of self-care skills will be implemented for 35 days during 10 sessions of 60 minutes (two sessions a week).
Main outcome variables
Self-care skills in patients with chronic schizophrenia; Positive and Negative Symptoms of Schizophrenia; Anxiety, Depression, Self-esteem
General information
Reason for update
The word group fits into the English title
Acronym
IRCT registration information
IRCT registration number:IRCT20180817040818N1
Registration date:2018-08-27, 1397/06/05
Registration timing:registered_while_recruiting
Last update:2020-08-27, 1399/06/06
Update count:2
Registration date
2018-08-27, 1397/06/05
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
2018-08-15, 1397/05/24
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
2018-08-15, 1397/05/24
Actual recruitment end date
2018-11-22, 1397/09/01
Trial completion date
2019-05-26, 1398/03/05
Scientific title
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills in Women with Chronic Schizophrenia
Public title
The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Primary admission with the diagnosis of schizophrenia
the diagnosis of chronic schizophrenia in the last 3 months
Duration of the disease recorded in the medical record was 3 years or more
Having verbal ability
Minimum grade 8th grade
Lack of standard dose change for anti psychotics in the past 3 months
Exclusion criteria:
A history of opium and alcohol abuse
History of conflict with legal issues
Severe physical illness requires treatment
Physical involvement with group members and therapists during treatment interventions
Unwillingness to continue attending in therapeutic sessions
Affected by epilepsy and mental retardation
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The random numbers table were assigned to intervention and control groups. A list of eligible patients was prepared and assigned a number to each of them. Then, a randomly selected number was selected randomly from the random numbers table and two digits to the right of it were considered. If the two digits on the right match the number of people listed, they were selected as the first person in the intervention group. and Subsequently, the numbers were assigned to the control group (in the case of the number of persons listed). This will continue until the sample size is completed in each group.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Vice chancellor for research, Mashhad University of Medical Sciences, next to the Hovezeh Cinema, University avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2018-07-18, 1397/04/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.298
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
Self care skills in patients with chronic schizophrenia
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Researcher-made Self Care Skills Questionnaire in Patients with Chronic Schizophrenia
2
Description
Positive and Negative Symptoms in Patients with Schizophrenia
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
3
Description
Anxiety
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Hamilton Anxiety Rating Scale
4
Description
Depression
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Hamilton Depression Rating Scale
5
Description
Self-Esteem
Timepoint
Before the intervention, two months after the intervention
Method of measurement
Eysenck Self-Esteem Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group was assigned to a cognitive-behavioral group
Category
Behavior
2
Description
Control group: they will receive routine care
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hejazi Psychiatric Hospital
Full name of responsible person
dr Ali Talaei
Street address
Hejazi psychiatric hospital, after Majlesi crossroad, Mashhad, Ebadi Avenue, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3732 6767
Fax
Email
TalaeiA@mums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vice chancellor for research; Mashhad University of Medical Sciences; next to the Hovezeh Cinema; University avenue; Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9919191778
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Kashani Lotfabadi
Position
Mashhad
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9317744839
Phone
+98 51371127017
Email
Kashanim1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Kashani Lotfabadi
Position
PhD in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9317744839
Phone
+98 371127017
Email
Kashanim1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoud Kashani Lotfabadi
Position
PhD in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Next Astan Ghods Naghlie, end Hor Ameli of the street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9317744839
Phone
+98 371127017
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
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
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
The results of this study will be open to the public in prestigious domestic and foreign journals
Under which criteria data/document could be used
If the ethics committee of Mashhad University of Medical Sciences approves, the data file will be usable
From where data/document is obtainable
Vice chancellor for research of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
To request documentation and data files, go to the Vice chancellor for research of Mashhad University of Medical Sciences