Determining the effectiveness of mindfulness based on cognitive therapy on attitude to life, quality of work life, resilience and happiness in employees.
Design
The current study is a randomized clinical trial. The study will be conducted as a pre-test-post-test with a random control group. The sample size is 60 people, 30 people are in the test group and 30 people are in the control group.
Settings and conduct
Study samples will be selected from among the employees of Tehran University of Medical Sciences. First, the examinees are invited to study through a call. In order to maintain blinding, this random sequence will be provided to the main researcher and then based on the created sequence, each group will be identified and placed in dark envelopes designed for this purpose, and each envelope will be numbered and envelope will be closed The person who will be in charge of sampling will open the envelopes based on the number of employees and will perform the intervention based on the group inside the envelope.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are employees working at the headquarters of Tehran University of Medical Sciences, having at least a bachelor's degree, not having a history of mental illness, and the criteria for leaving the study are not participating in more than three sessions and not agreeing to participate in the research.
Intervention groups
Employees of Tehran University of Medical Sciences
Main outcome variables
attitude to life, quality of work life, resilience and happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231118060094N1
Registration date:2023-12-23, 1402/10/02
Registration timing:registered_while_recruiting
Last update:2023-12-23, 1402/10/02
Update count:0
Registration date
2023-12-23, 1402/10/02
Registrant information
Name
Fariba Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3615
Email address
fakbari@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness based on cognitive therapy on attitude to life, quality of work life, resilience and happiness in employees
Public title
The effectiveness of mindfulness based on cognitive therapy on attitude to life, quality of work life, resilience and happiness
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Employees working in the headquarters of Tehran University of Medical Sciences
Have at least a bachelor's degree
No history of mental illness
Exclusion criteria:
Not attending more than three sessions
Not agreeing to participate in the research
Age
From 22 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the method of random blocks with size 4 will be used, and the random sequence will be generated by the statistician and by the software. In order to maintain blinding, this random sequence will be chosen by the main researcher and then based on the created sequence, each specific group will be placed in envelopes designed for this purpose, and each envelope will have a reported number and a closed envelope. becomes will be. Before starting the study, all participants (control and intervention groups) will complete the pre-test questionnaire. The experimental group will receive cognitive therapy training based on mindfulness for 8 sessions of 120 minutes, while the control group will not receive any training. One month after training the intervention group, all participants in the study will complete the post-test questionnaire.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to maintain blinding, the random sequence will be provided to the main researcher and then based on the created sequence, each group will be identified and placed in dark envelopes designed for this purpose.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Nosrat st. Tohid sq.
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2023-10-15, 1402/07/23
Ethics committee reference number
IR.TUMS.FNM.REC.1402.156
Health conditions studied
1
Description of health condition studied
attitude to life
ICD-10 code
Y98
ICD-10 code description
Lifestyle-related condition
2
Description of health condition studied
quality of work life
ICD-10 code
Y96
ICD-10 code description
Work-related condition
3
Description of health condition studied
resilience
ICD-10 code
Z72.8
ICD-10 code description
Other problems related to lifestyle/ Self-damaging behaviour
4
Description of health condition studied
happiness
ICD-10 code
F34.8
ICD-10 code description
Other persistent mood [affective] disorders
Primary outcomes
1
Description
attitude to life, quality of work life, resilience and happiness
Timepoint
At the beginning of the study, after the intervention
Method of measurement
Batista LRI Life Attitude Questionnaire, Oxford Happiness Questionnaire, Quality of Work Life Questionnaire (QWL), Freiburg Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the supplemental pre-test questionnaire will be started, then for 8 sessions of 120 minutes, they will receive the intervention therapy training about mindfulness, after the session, the post-test training will be completed.
Category
Behavior
2
Description
Control group: In the control group, the pre-test questionnaire will be completed first, after two months, the post-test questionnaire will be completed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
University headquarters
Full name of responsible person
Fariba Akbari
Street address
The central building of the university. Quds St. Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3615
Fax
+98 21 8163 3628
Email
fakbari@farabi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Street address
The central building of the university. Quds St. Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3615
Email
fakbari@farabi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personal credit
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Position
the expert
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Room 604. sixth floor. Central Organization of Tehran University of Medical Sciences. corner of Qods St. Keshavarz Boulevard.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3615
Email
fakbari@farabi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Position
the expert
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
6th floor, room 604, Tehran University of Medical Sciences, Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3615
Email
fakbari@farabi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fariba Akbari
Position
the expert
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
6th floor, room 604, Tehran University of Medical Sciences, Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3615
Email
fakbari@farabi.tums.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available