Protocol summary
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Study aim
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Determining the effect of cognitive behavioral group therapy on improving self-care skills in women with chronic schizophrenia
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Design
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In this randomized clinical trial, 40 women with chronic schizophrenia were selected randomly and then randomly assigned to two groups of intervention and control
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Settings and conduct
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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
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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).
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Main outcome variables
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Self-care skills in patients with chronic schizophrenia; Positive and Negative Symptoms of Schizophrenia; Anxiety, Depression, Self-esteem
General information
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Reason for update
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Correction of some clinical trial information
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180817040818N1
Registration date:
2018-08-27, 1397/06/05
Registration timing:
registered_while_recruiting
Last update:
2020-09-05, 1399/06/15
Update count:
2
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Registration date
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2018-08-27, 1397/06/05
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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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2018-08-15, 1397/05/24
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Expected recruitment end date
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2018-10-23, 1397/08/01
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Actual recruitment start date
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2018-08-15, 1397/05/24
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Actual recruitment end date
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2018-11-22, 1397/09/01
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Trial completion date
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2019-05-26, 1398/03/05
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Scientific title
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The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills in Women with Chronic Schizophrenia
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Public title
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The Effect of Cognitive-Behavioral Group Therapy on Improving Self-Care Skills
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Purpose
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Other
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Inclusion/Exclusion criteria
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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
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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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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2018-07-18, 1397/04/27
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1397.298
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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Self care skills in patients with chronic schizophrenia
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Timepoint
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Before intervention, after intervention, six months after intervention
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Method of measurement
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Researcher-made Self Care Skills Questionnaire in Patients with Chronic Schizophrenia
2
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Description
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Positive and Negative Symptoms in Patients with Schizophrenia
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Timepoint
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Before intervention, after intervention, six months after intervention
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Method of measurement
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Positive and Negative Syndrome Scale (PANSS)
3
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Description
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Anxiety
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Timepoint
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Before intervention, after intervention, six months after intervention
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Method of measurement
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Hamilton Anxiety Rating Scale
4
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Description
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Depression
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Timepoint
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Before intervention, after intervention, six months after intervention
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Method of measurement
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Hamilton Depression Rating Scale
5
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Description
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Self-Esteem
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Timepoint
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Before intervention, after intervention, six months after intervention
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Method of measurement
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Eysenck Self-Esteem Questionnaire
Intervention groups
1
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Description
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The intervention group was assigned to a cognitive-behavioral group
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Category
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Behavior
2
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Description
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Control group: they will receive routine care
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Category
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N/A
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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Mashhad University of Medical Sciences
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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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Public
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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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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is 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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The results of this study will be open to the public in prestigious domestic and foreign journals
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Under which criteria data/document could be used
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If the ethics committee of Mashhad University of Medical Sciences approves, the data file will be usable
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From where data/document is obtainable
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Vice chancellor for research of Mashhad University of Medical Sciences
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What processes are involved for a request to access data/document
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To request documentation and data files, go to the Vice chancellor for research of Mashhad University of Medical Sciences
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Comments
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