View older revisions Content changed at 2019-03-10, 1397/12/19

Protocol summary

Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Having at least one year of work experience in one of the technical units of Tamkar-Industial Company’.
Intervention groups
First Intervention Group : Mindfulness-Based Cognitive Therapy Group (MBCT) Second Intervention Group: Made Questionnaire Group (MQ) Third Group: Control Group
Main outcome variables
The score of Job Stress, The score of Anxiety, The score of Depression and The score of Burnout

General information

Reason for update
Acronym
IRCT registration information
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
Registration date
2019-03-10, 1397/12/19
Registrant information
Name
Somayeh Gorji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3653 2957
Email address
somayeh.gorji@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
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
Purpose
Education/Guidance
Inclusion/Exclusion criteria
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.
Age
From 21 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
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
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
Islamic Republic of Iran Ministry of Health & Medical Education Deputy of Research & Technology Nati
Street address
NO 13, Block A, St Arghavaniye, Khorasgan Univercity Isfahan. Isfahan.
City
Isfahan
Province
Isfehan
Postal code
3999881551
Approval date
2018-12-29, 1397/10/08
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.167

Health conditions studied

1

Description of health condition studied
Job Stress, Anxiety, Depression and Burnout
ICD-10 code
F48.8
ICD-10 code description
Occupational neurosis, including writer cramp

Primary outcomes

1

Description
The score of depression via Beck Depression Inventory
Timepoint
Measuring the score of depression via Beck Depression Inventory before, immediately & 1 month after intervention.
Method of measurement
Beck Depression Inventory

2

Description
The score of anxiety via Beck anxiety Inventory
Timepoint
Measuring the score of anxiety via Beck anxiety Inventory before, immediately & 1 month after intervention.
Method of measurement
Beck anxiety Inventory

3

Description
The score of Job Stress via Job Stress Questioner.
Timepoint
Measuring the score of Job Stress via Job Stress Questioner before, immediately & 1 month after intervention
Method of measurement
Job Stress Questioner

Secondary outcomes

1

Description
The score of job burnout
Timepoint
before, immediately & 1 month after intervention
Method of measurement
Geldard Burnout Inventory

Intervention groups

1

Description
First Intervention group : learning Mindfulness-Based Cognitive Therapy throw 10 section
Category
Treatment - Other

2

Description
second Intervention group: learning new didactic pack throw 10 section
Category
Treatment - Other

3

Description
Control group: will receive anything
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran Chemical Industry Investment Company
Full name of responsible person
Somayeh Gorji
Street address
The Post Of The Shahid Montazery Powerhouse, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8335144114
Phone
+98 31 3380 8350
Email
s.gorji90@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tamkar-Industial Company
Full name of responsible person
Mohammad Reza Brekatain
Street address
No. 159, Dolat Abad St., Baharestan Indusrerial Ave., Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8341645973
Phone
+98 31 4583 6071
Email
info@iranpetrotech.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tamkar-Industial Company
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
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Gorji
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Sahel Bloc., Tohid St., Sepahanshar Town
City
Isfahan
Province
Isfehan
Postal code
8173787946
Phone
+98 31 3653 2957
Fax
Email
somayeh.gorji@khuisf.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Gorji
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Sahel Bloc., Tohid St., Sepahanshar Town
City
Isfahan
Province
Isfehan
Postal code
8173787946
Phone
+98 31 3653 2957
Fax
Email
somayeh.gorji@khuisf.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Gorji
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 1, Sahel Bloc., Tohid St., Sepahanshar Town
City
Isfahan
Province
Isfehan
Postal code
8173787946
Phone
+98 31 3653 2957
Fax
Email
somayeh.gorji@khuisf.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of the demographic information Independent & dependent variables Results
When the data will become available and for how long
About tow or three month after the end of intervention.
To whom data/document is available
All of the researchers in humanism fields.
Under which criteria data/document could be used
Its useful for studies in humanism fields and that is free.
From where data/document is obtainable
Throw e.mail to author: somayeh.gorji@khuisf.ac.ir
What processes are involved for a request to access data/document
Throw e.mail to author: somayeh.gorji@khuisf.ac.ir
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