Protocol summary

Study aim
The present study was conducted with the aim of determining the effectiveness of mindfulness-based stress reduction training on the level of mental health and salivary cortisol and α-amylase levels of students.
Design
Semi-experimental studies with pre-test-post-test-follow-up design and control group, one-sided blind, randomized, performed on 15 subjects.
Settings and conduct
After obtaining the necessary permission from Baqiyatullah University of Medical Sciences (AS), the relevant universities in the target community were referred and according to the entry criteria, 30 people were selected. In order to carry out the research, in the pre-test phase, first a saliva sample was taken to determine the concentration of cortisol and the amount of salivary α-amylase in resting conditions (8-9 am before breakfast) and then the stress, anxiety and depression scale (DASS-21) and The General Health Questionnaire (GHQ-28) is completed on the same day.
Participants/Inclusion and exclusion criteria
entry: obtaining a score higher than 14 in the depression and anxiety subscales and higher than 18 in the stress subscale of the Stress, Anxiety and Depression Questionnaire (DASS-21); age range 18 to 25; Exclusion: presence or history of severe psychiatric disorder; smoking and psychoactive pills; taking psychiatric drugs; epilepsy; diabetes; hypothyroidism or hyperthyroidism; Edison; Cushing syndrome; High blood pressure; Taking corticosteroids and steroids.
Intervention groups
The subjects of the experimental group will be trained in mindfulness-based stress reduction intervention by the researcher during 8 sessions of 90 minutes per week, and the control group will be informed that they are on the waiting list and after the end of the intervention of the first group, the intervention in The second group is also done
Main outcome variables
Mental health; Cortisol levels; Salivary α-amylase

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190927044898N1
Registration date: 2023-06-28, 1402/04/07
Registration timing: retrospective

Last update: 2023-06-28, 1402/04/07
Update count: 0
Registration date
2023-06-28, 1402/04/07
Registrant information
Name
reza mohammadzadeghan
Name of organization / entity
Azarbaijan Shahid Madani University
Country
Iran (Islamic Republic of)
Phone
+98 44 3633 8394
Email address
reza.moh1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-01, 1400/05/10
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2021-08-01, 1400/05/10
Actual recruitment end date
2021-09-22, 1400/06/31
Trial completion date
2021-09-22, 1400/06/31
Scientific title
Effectiveness of Mindfulness-Based Stress Reduction on Mental Health, Salivary Cortisol and α-amylase level in students
Public title
The Effectiveness of Mindfulness-Based Stress Reduction on Mental Health and Salivary cortisol and α-amylase
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Score above 14 on the Depression and Anxiety subscales and above 18 on the Stress subscale of the Stress of DASS-21 The age range of 18 to 25 Sign the ethical consent Minimum education of reading and writing
Exclusion criteria:
Existence or history of severe psychiatric disorder Smoking and psychotropic pills Use of psychiatric drugs Epilepsy Various cardiovascular and respiratory and blood pressure disorders Aspirin use a acetaminophen over the past 48 hours A history of cancer Diabetes Hypothyroidism or hyperthyroidism Addison, cushing's and cushing's syndrome, hypertension, corticosteroid and steroid medications.
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be one-way blinded, the participants of two groups will be blinded to receive the intervention
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatullah Hospital
Street address
South Sheikh Bahai Street, Molla Sadra Street, Vanak Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2020-05-05, 1399/02/16
Ethics committee reference number
IR.BMSU.BAQ.REC.1399.004

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41:
ICD-10 code description
Other anxiety disorders

2

Description of health condition studied
Depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes

Primary outcomes

1

Description
Improve mental health
Timepoint
The subjects of the two groups will complete the DASS-21 and GHQ-28 questionnaires in the pre-test and post-test phases.
Method of measurement
Stress, Anxiety and Depression Scale (DASS-21) and General Health Questionnaire (GHQ-28)

2

Description
Decreased levels of cortisol and alpha-amylase
Timepoint
Saliva collection in this study was done in two stages: pre-test (before the intervention and during rest) and post-test (after the intervention).
Method of measurement
To collect saliva samples, the participants are asked to passively collect their secreted saliva for 5 minutes in designated tubes.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The first group - the recipient of mindfulness intervention
Category
Treatment - Other

2

Description
Control group: They did not receive any special intervention and were on the waiting list
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatullah University of Medical Sciences
Full name of responsible person
shima shahyad
Street address
Neuroscience Research Center, South Sheikh Bahai Street, Mollasadra St., Vanak Square, Tehran
City
Teran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4148
Email
research.bmsu@gmail.com
Web page address
https://www.bmsu.ac.ir/portal/home/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Dr. Hassan Abul Qasimi
Street address
South Sheikh Bahai Street, Molla Sadra Street, Vanak Square, Tehran, Ir
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 4574
Email
R.bmsu@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Mohammadzadeghan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Zeynali 2 Alley, Neighborhood of No. 94 Dastgah, Shams Tabrizi Boulevard, Khoy, Iran
City
Khoy
Province
Tehran
Postal code
58718744747
Phone
+98 44 3633 8394
Email
reza.moh1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Mohammadzadeghan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Zeynali 2 Alley, Neighborhood of No. 94 Dastgah, Shams Tabrizi Boulevard, Khoy, Iran
City
Khoy
Province
West Azarbaijan
Postal code
5818744747
Phone
+98 44 3633 8394
Email
reza.moh1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Reza Mohammadzadeghan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Zeynali 2 Alley, Neighborhood of No. 94 Dastgah, Shams Tabrizi Boulevard, Khoy, Iran
City
Khoy
Province
West Azarbaijan
Postal code
5818744747
Phone
+98 44 3633 8394
Email
reza.moh1@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data file and collected samples and executed questionnaires and protocol
When the data will become available and for how long
Whenever needed
To whom data/document is available
For all but no participant identification information
Under which criteria data/document could be used
Any type of analysis is allowed
From where data/document is obtainable
reza mohammadzadeghan
What processes are involved for a request to access data/document
After email within 1 working week
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