<?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>IRCT20260516069420N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-13</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>effect of mindfulness-based cognitive behavioral therapy on sleep quality, emotional regulation, and Test anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of mindfulness-based cognitive behavioral therapy on sleep quality, emotional regulation, and Test anxiety in female high school students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90726</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Initially, based on the inclusion and exclusion criteria, 60 subjects will be selected using a cluster method, and after a pre-test with a 50% probability of failure, 30 subjects will be assigned to two groups of 18 people, the experimental and control groups, by simple random method and by drawing lots. Regarding the method of drawing lots, one name from each name that comes out of the bag of names will be placed in the experimental group and the next name will be placed in the control group.</study_design>
      <phase>1</phase>
      <hc_freetext>Condition 1: sleep quality. Condition 2: Emotional regulation. Condition 3: Test anxiety.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The experimental group underwent mindfulness-based cognitive behavioral therapy training for ten 90-minute sessions over a period of two months. In each session, the experimental group was given practical exercises and homework and activities for the following sessions were also reviewed (Sari et al., 2022). This treatment protocol is adapted from the Kabat-Zinn protocol (2000). Intervention 2: Control group: The control group did not receive any intervention or training for two months after completing the pre-test. After the last training session of the experimental group, the control group was administered the post-test by distributing the same questionnaires as the pre-test.</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:
All information and data collected will be shared after being de-identified to aid in related studies and future research.

When:
Data access will begin 6 months after the results are published.

To whom:
Psychology professors, researchers, and students are allowed to submit requests to receive data and other documentation.

Conditions:
The data will be used to develop future research results and meta-analyses.

Where to obtain:
Applicants can contact the corresponding author by email to receive the data.

How to obtain:
Applicants will be able to receive the data within one month after submitting their request, along with research documentation demonstrating the necessity of the data to achieve the research goals.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hadis Bagherzadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.125, Alley 7, Jahad Blvd., Esteghlal Town.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7189853443</zip>
        <telephone>+98 937 599 3542</telephone>
        <email>bagherzadeh.hadis6@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Somaye Zare</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 33, 3rd floor, Bagh Safa Building, next to Islamic Revolution Housing Foundation, Imam Hussein Square towards Bagh Safa Bridge</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7135713497</zip>
        <telephone>+98 71 3230 8655</telephone>
        <email>Somayezare60@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having informed consent and willingness to actively participate in all stages of the research
Not taking any specific psychiatric medications in the past six months
Achieving a quorum on the pre-test of sleep quality, emotion regulation, and test anxiety in order to be eligible to receive the intervention</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Expressing unwillingness to continue working with the researcher at any stage of the research
Having new chronic or acute physical illnesses that could potentially affect sleep quality, emotion regulation, or test anxiety levels
The occurrence of major family issues or crises, such as bereavement, parental divorce, or severe financial difficulties, which can significantly affect the subject's mental state or responses</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The experimental group underwent mindfulness-based cognitive behavioral therapy training for ten 90-minute sessions over a period of two months. In each session, the experimental group was given practical exercises and homework and activities for the following sessions were also reviewed (Sari et al., 2022). This treatment protocol is adapted from the Kabat-Zinn protocol (2000).</i_keyword>
      <i_keyword>Control group: The control group did not receive any intervention or training for two months after completing the pre-test. After the last training session of the experimental group, the control group was administered the post-test by distributing the same questionnaires as the pre-test.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Sleep quality. Timepoint: This variable is measured once before the start of the intervention and a second time, after the intervention period, by post-test. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</prim_outcome>
      <prim_outcome>Emotional Regulation. Timepoint: This variable is measured once before the start of the intervention and a second time, after the intervention period, by post-test. Method of measurement: Gross and John's Emotional Regulation Questionnaire (2003).</prim_outcome>
      <prim_outcome>Test Anxiety. Timepoint: This variable is measured once before the start of the intervention and a second time, after the intervention period, by post-test. Method of measurement: Dries Cole Test Anxiety Questionnaire (2007).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-04-14</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Shiraz Branch</contact_name>
        <contact_address>Faculty of Dentistry, Alley 14, South Ghaani Street Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
