Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Positive, negative symptoms and general psychopathology, self-care
General information
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Reason for update
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Correction of sample size and completion date of sampling
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Acronym
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IRCT registration information
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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
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Registration date
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2020-08-23, 1399/06/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-07-19, 1399/04/29
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Expected recruitment end date
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2020-10-11, 1399/07/20
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Actual recruitment start date
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2020-07-22, 1399/05/01
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Actual recruitment end date
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2020-10-31, 1399/08/10
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Trial completion date
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2021-05-20, 1400/02/30
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Scientific title
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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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Public title
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The Effect of Cognitive-Behavioral Group Training of Self-Care Skills on Positive, Negative Symptoms, General psychopathology and Self-Care
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 25 years old to 55 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
52
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The researcher who performs the study statistics will be blind to the study conditions.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-07-18, 1399/04/28
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Ethics committee reference number
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IR.IAU.TJ.REC.1399.007
Health conditions studied
1
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Description of health condition studied
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Schizophrenia
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ICD-10 code
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F20-F29
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ICD-10 code description
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Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
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Description
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Positive, negative symptoms and general psychopathology
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Timepoint
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Before intervention, after intervention and six months after intervention
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Method of measurement
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Positive and Negative Clinical Syndrome Scale (PANSS)
2
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Description
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Self- care
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Timepoint
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Before intervention, after intervention and six months after intervention
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Method of measurement
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Self-Care Needs Scale (SCRS-H)
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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Control group: They will receive the routine care.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Islamic Azad university Torbat-e Jam branch
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Clinical outcomes of the study will be published in the form of a paper
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When the data will become available and for how long
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The results of the study will be published after data collection over the next 6 months
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To whom data/document is available
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Data documents will be shared in thesis and article form.
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Under which criteria data/document could be used
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Islamic Azad university Torbat-e Jam branch license will only be available to researchers working in academic institutions
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From where data/document is obtainable
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Islamic Azad university Torbat-e Jam branch license will only be available to researchers working in academic institutions
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What processes are involved for a request to access data/document
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It should be done through the research vice chancellor of Islamic Azad university Torbat-e Jam branch.
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Comments
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