Protocol summary

Study aim
The aim of the present study is to compare the effectiveness of Learning to BREATHE Curriculum and MBSR on academic resilience, psychological well-being, self-compassion, and anxiety symptoms in students.
Design
Sampling and research implementation diagram Research design diagram Random assignment of groups Pre-test Intervention Post-test R Experiment "A" and "T" T1 X T2 R Experiment "B" and "C" T1 Y T2 R Control "C" and "P" T1 - T2 The present study was conducted in the form of a randomized clinical trial with a control group and in a pre-test-post-test method. After selecting the schools, 45 high school students from each school were randomly divided into 3 different groups (classes).
Settings and conduct
Interventions and control groups in boys' schools were conducted by the first author of this study, who has 3 years of experience in implementation of mindfulness, and the research in girls' schools was also conducted by 3 female psychology experts
Participants/Inclusion and exclusion criteria
The inclusion criteria for the present study included the following: being a second-year high school student, not having a definitive diagnosis of one of the mental disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, consent and willingness to participate in the study, and signing a written consent form by the student and one of the parents. The exclusion criteria for the study included the following: attending psychotherapy sessions, yoga, meditation, and educational-therapeutic programs concurrently with the intervention, and missing more than 2 sessions.
Intervention groups
L2b group, MBSR, active control group
Main outcome variables
academic resilience, psychological well-being, self-compassion, anxiety symptoms

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250907067153N1
Registration date: 2025-11-13, 1404/08/22
Registration timing: prospective

Last update: 2025-11-13, 1404/08/22
Update count: 0
Registration date
2025-11-13, 1404/08/22
Registrant information
Name
Alireza Eivaznezhad Firouzsalari
Name of organization / entity
University of Mohaghegh Ardabili
Country
Iran (Islamic Republic of)
Phone
+98 902 114 2454
Email address
a.eivaznezhad@student.uma.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-16, 1404/08/25
Expected recruitment end date
2025-11-22, 1404/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of learning to BREATHE curriculum and mindfulness-based stress reduction on academic resilience, psychological well-being, self-compassion, and Symptoms of anxiety in students
Public title
effectiveness of learning to BREATHE curriculum and mindfulness-based stress reduction in adolecsents
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being a second-year high school student not having a definitive diagnosis of one of the mental disorders listed in the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition consent and willingness to participate in the research signing a written consent form by the student and one of the parents.
Exclusion criteria:
Attending psychotherapy, yoga, meditation, and educational-therapeutic programs simultaneously with the intervention Absence of more than 2 sessions
Age
From 11 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 95
Randomization (investigator's opinion)
Randomized
Randomization description
This research was conducted as aد Experimental study with a pretest-posttest design with an active control group. The statistical population was all adolescents studying in the second high school level of Ardabil city in the academic year 2024-2025 (25,000 people). From this population, 90 adolescents (45 girls and 45 boys) were selected through cluster random sampling (random selection of classes from the second high schools of Ardabil). Randomization was performed in different stages using SPSS (Data – select cases – random sample of cases) software, and allocation was done using sealed envelopes by an independent researcher. After receiving the necessary permits from the University of Mohaghegh Ardabili (ethics code: IR.UMA.REC.1404.020) and the Ardabil Provincial Education and Training Department, obtaining written consent from parents and students, and random allocation, the intervention was implemented.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
University of Mohaghegh Ardabili (Research Ethics Committee)
Street address
Police Square, University Boulevard, University of Mohaghegh Ardabili
City
Ardabil
Province
Ardabil
Postal code
1313156199
Approval date
2025-04-30, 1404/02/10
Ethics committee reference number
IR.UMA.REC.1404.020

Health conditions studied

1

Description of health condition studied
high levels of anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
Academic Resilience Inventory
Timepoint
At pre-test and before the intervention begins - immediately after the intervention ends
Method of measurement
Academic Resilience Inventory Samuel (2004)

2

Description
Psychological well-being
Timepoint
At pre-test and before the intervention begins - immediately after the intervention ends
Method of measurement
Ryff scale psychological well being-18 question version (1989)

3

Description
Self-Compassion
Timepoint
At pre-test and before the intervention begins - immediately after the intervention ends
Method of measurement
Neff's self-compassion scale (2003)

4

Description
Anxiety disorders symptoms
Timepoint
At pre-test and before the intervention begins - immediately after the intervention ends
Method of measurement
Birmaher Screen for Child Anxiety Related Disorders (1999) - The child's version

Secondary outcomes

empty

Intervention groups

1

Description
Learning to BREATHE group of boys and girls
Category
Prevention

2

Description
Mindfulness-based stress reduction intervention group for boys and girls
Category
Prevention

3

Description
Active control group: Daily conversation with adolescents with empathy and active listening
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili
Full name of responsible person
Alireza Eivaznezhad
Street address
Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
13131-56199
Phone
+98 902 114 2454
Email
alirezaeivpsy@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Mohammad Narimani
Street address
Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
13131-56199
Phone
+98 914 151 9794
Email
narimani@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mohaghegh Ardabili
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
University of Mohaghegh Ardabili
Full name of responsible person
Alireza Eivaznezhad
Position
M.A in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
13131-56199
Phone
+98 45 3150 5000
Email
alirezaeivpsy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Alireza Eivaznezhad
Position
M.A in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
13131-56199
Phone
+98 45 3150 5000
Email
alirezaeivpsy@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Alireza Eivaznezhad
Position
M.A in General Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran
City
Ardabil
Province
Ardabil
Postal code
13131-56199
Phone
+98 45 3150 5000
Email
alirezaeivpsy@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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be available after being de-identified.
When the data will become available and for how long
Numerical and statistical data will be available from the next 3 months, and any researcher can receive numerical data by making a formal and reasonable request. These data will be available for life.
To whom data/document is available
Formal applications from individuals employed at academic institutions are acceptable.
Under which criteria data/document could be used
This data is for review and review purposes only and is not permitted for analysis.
From where data/document is obtainable
Contact Mr. Alireza Eivaznezhad via email.
What processes are involved for a request to access data/document
First, an official letter with university or journal letterhead should be sent to us. After review and approval by the Faculty of Educational Sciences and Psychology, the data will be delivered.
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