<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20250907067153N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-13</date_registration>
      <primary_sponsor>University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>effectiveness of learning to BREATHE curriculum and mindfulness-based stress reduction in adolecsents</public_title>
      <acronym></acronym>
      <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</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>95</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86015</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, 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.</study_design>
      <phase>N/A</phase>
      <hc_freetext>high levels of anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Learning to BREATHE group of boys and girls. Intervention 2: Mindfulness-based stress reduction intervention group for boys and girls. Intervention 3: Active control group: Daily conversation with adolescents with empathy and active listening.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The data will be available after being de-identified.

When:
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:
Formal applications from individuals employed at academic institutions are acceptable.

Conditions:
This data is for review and review purposes only and is not permitted for analysis.

Where to obtain:
Contact Mr. Alireza Eivaznezhad via email.

How to obtain:
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.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Alireza Eivaznezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13131-56199</zip>
        <telephone>+98 45 3150 5000</telephone>
        <email>alirezaeivpsy@gmail.com</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Alireza Eivaznezhad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Dean’s Office (Dr. Mohammad Narimani), Faculty of Educational Sciences and Psychology, University of Mohaghegh Ardabili, Daneshgah Boulevard, Police Square, Ardabil, Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13131-56199</zip>
        <telephone>+98 45 3150 5000</telephone>
        <email>alirezaeivpsy@gmail.com</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <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.</inclusion_criteria>
      <agemin>11 years</agemin>
      <agemax>19 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Attending psychotherapy, yoga, meditation, and educational-therapeutic programs simultaneously with the intervention
Absence of more than 2 sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Learning to BREATHE group of boys and girls</i_keyword>
      <i_keyword>Mindfulness-based stress reduction intervention group for boys and girls</i_keyword>
      <i_keyword>Active control group: Daily conversation with adolescents with empathy and active listening</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>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).</prim_outcome>
      <prim_outcome>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).</prim_outcome>
      <prim_outcome>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).</prim_outcome>
      <prim_outcome>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.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>University of Mohaghegh Ardabili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-30</approval_date>
        <contact_name>University of Mohaghegh Ardabili (Research Ethics Committee)</contact_name>
        <contact_address>Police Square, University Boulevard, University of Mohaghegh Ardabili Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
