Protocol summary
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Study aim
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The present study intended to Develop a Phenomenological Model of Coping with Job Stress and Compar the Effectiveness of this Model with Mindfulness-Based Cognitive Therapy on Perceived Job Stress, Anxiety, Depression and Burnout of Tamkar-Industial Company’s Employees.
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Design
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Three arm parallel groups randomized trial without blinded assessment. A number of 60 employees, will be enrolled between April 2019 and May 2019, and followed for one month.
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Settings and conduct
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A clinical trial study will perform to see whether or not (MBCT) and (MQ) have an effect on Job Stress, Anxiety, Depression and Burnout . A number of 60 employees who have worked at least 1 year in the technical wards of Iran Chemical Industry Investment Company, will take part in the study. The participants randomly will be assigned to three groups of control (n=20), MBCT (n=20), and MQ (n=20). The MBCT group will participate in MBCT class and the MQ group will participate in MQ class for 10 sections . The control group, on the other hand, will receive anything.
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Participants/Inclusion and exclusion criteria
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Having at least one year of work experience in one of the technical units of Tamkar-Industial Company’.
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Intervention groups
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First Intervention Group : Mindfulness-Based Cognitive Therapy Group (MBCT)
Second Intervention Group: Made Questionnaire Group (MQ)
Third Group: Control Group
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Main outcome variables
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The score of Job Stress,
The score of Anxiety,
The score of Depression and
The score of Burnout
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20190122042451N2
Registration date:
2019-03-10, 1397/12/19
Registration timing:
registered_while_recruiting
Last update:
2019-03-10, 1397/12/19
Update count:
1
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Registration date
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2019-03-10, 1397/12/19
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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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2019-02-20, 1397/12/01
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Expected recruitment end date
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2020-02-20, 1398/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Developing a Phenomenological Model of Coping with Job Stress and Comparing the Effectiveness of this Model with Mindfulness-Based Cognitive Therapy on Perceived Job Stress, Anxiety, Depression and Burnout of Tamkar-Industial Company’s Employees.
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Public title
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Developing a Phenomenological Model of Coping with Job Stress and Comparing the Effectiveness of this Model with Mindfulness-Based Cognitive Therapy on Perceived Job Stress, Anxiety, Depression and Burnout
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
being interested in attending the study,
having at least one year of work experience in one of the technical units of Tamkar-Industial Company.
no history of psychotic disorders , and taking the related medications.
working in a day shift
not facing everyday life stressful events such as a death, divorce and other miserable events in a year prior to the study
Exclusion criteria:
Facing everyday life stressful events such as a death, divorce and other miserable events in a year prior to the study
Beginning to take the medications related to psychotic disorders
being absence for tree or more sections.
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Age
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From 21 years old to 60 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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No information
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Through a random selection, 60 staff were randomly selected and assigned to two groups study and control by subjects’ selection of a color ball from a box
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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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2018-12-29, 1397/10/08
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Ethics committee reference number
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IR.IAU.KHUISF.REC.1397.167
Health conditions studied
1
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Description of health condition studied
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Job Stress, Anxiety, Depression and Burnout
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ICD-10 code
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F48.8
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ICD-10 code description
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Occupational neurosis, including writer cramp
Primary outcomes
1
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Description
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The score of depression via Beck Depression Inventory
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Timepoint
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Measuring the score of depression via Beck Depression Inventory before, immediately & 1 month after intervention.
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Method of measurement
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Beck Depression Inventory
2
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Description
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The score of anxiety via Beck anxiety Inventory
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Timepoint
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Measuring the score of anxiety via Beck anxiety Inventory before, immediately & 1 month after intervention.
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Method of measurement
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Beck anxiety Inventory
3
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Description
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The score of Job Stress via Job Stress Questioner.
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Timepoint
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Measuring the score of Job Stress via Job Stress Questioner before, immediately & 1 month after intervention
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Method of measurement
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Job Stress Questioner
Secondary outcomes
1
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Description
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The score of job burnout
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Timepoint
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before, immediately & 1 month after intervention
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Method of measurement
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Geldard Burnout Inventory
Intervention groups
1
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Description
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First Intervention group : learning Mindfulness-Based Cognitive Therapy throw 10 section
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Category
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Treatment - Other
2
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Description
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second Intervention group: learning new didactic pack throw 10 section
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Category
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Treatment - Other
3
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Description
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Control group: will receive anything
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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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Tamkar-Industial Company
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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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Industry
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is 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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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Some of the demographic information
Independent & dependent variables
Results
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When the data will become available and for how long
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About tow or three month after the end of intervention.
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To whom data/document is available
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All of the researchers in humanism fields.
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Under which criteria data/document could be used
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Its useful for studies in humanism fields and that is free.
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From where data/document is obtainable
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Throw e.mail to author: somayeh.gorji@khuisf.ac.ir
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What processes are involved for a request to access data/document
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Throw e.mail to author: somayeh.gorji@khuisf.ac.ir
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Comments
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