<?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>IRCT20250827067020N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-01</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of mindfulness training based on stress reduction on sleep quality and anxiety</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of mindfulness training based on stress reduction on sleep quality and anxiety in students with generalized anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/89713</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention group: Mindfulness-based stress reduction is a group program developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life problems and physical or mental illnesses. Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The standard order of each session will include a review of homework from the previous session, feedback on resolving existing questions and problems, teaching the intended content and techniques, meditation skills, discussing stress and coping methods, and assigning homework. The content presented during the 8 sessions will include the following: introduction to mindfulness training, training and doing exercises related to the state of mindfulness exercises, practicing paying attention to breathing, doing body scan exercises, doing sitting meditation, doing yoga movements, practicing mindful eating, practicing mindful walking meditation, and creating a personal mindfulness plan. Participants are asked to do mindfulness exercises for 45 minutes daily as homework. Number of treatment sessions: 8 sessions, 30 to 60 minutes, once a week, treatment is done individually..</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:
Results, tables and treatment protocol

When:
6 months after results are published

To whom:
Applicants from qualified individuals (general practitioners, medical specialists, psychiatrists, psychologists)

Conditions:
The use of the documentation of this trial will only be possible for academic and scientific researchers on a limited basis and with permission from the person responsible for this trial.

Where to obtain:
Correspondence via email address mobina.sadeghifarr@gmail.com

How to obtain:
Any request for access to data or documentation from this study must be made by sending a formal written request to the principal investigator or supervisor. This request must include the applicant's details, the purpose of using the data, the type of data required, and how to ensure the confidentiality of the information. After receiving the request, the following will be reviewed: Verification of the applicant's scientific identity and organizational affiliation Evaluation of the research purpose and its alignment with the ethical principles of the study Final approval by the principal investigator and, if necessary, the university ethics committee If approved, the data will be provided to the applicant in an anonymized and limited to the requested items, in a scientifically usable format. Use of the data is permitted only with acknowledgement of the source and observance of the confidentiality of the participants' information.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>KHADIJEH HATAMIPOUR</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5 kilometers to Tonekabon City - Vali Abad</address>
        <city>TONEKABON</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4684161167</zip>
        <telephone>+98 11 5427 1105</telephone>
        <email>kh_hatamipour@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>MOBINA SADEGHIFAR</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 12 ,floor 4, damoun 1 complex, bahmani alley, Razi ave</address>
        <city>Tonekabon</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4681966869</zip>
        <telephone>+98 11 5422 7267</telephone>
        <email>mobina.sadeghifarr@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All individuals are studying at the undergraduate level in the nursing department of Islamic Azad University, Tonekabon Branch
Those who achieve a quorum score on the Spitzer et al. Generalized Anxiety Disorder Test
Written consent to participate in the study</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No psychiatric medication in the past 6 months up to the time of the study
Not receiving psychotherapy in the past 6 months up to the time of the study
Refusal to participate in the study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Mindfulness-based stress reduction is a group program developed by Jon Kabat-Zinn in the 1970s to treat patients struggling with life problems and physical or mental illnesses. Mindfulness-based stress reduction is an 8-week training program that uses formal and informal mindfulness exercises. The standard order of each session will include a review of homework from the previous session, feedback on resolving existing questions and problems, teaching the intended content and techniques, meditation skills, discussing stress and coping methods, and assigning homework. The content presented during the 8 sessions will include the following: introduction to mindfulness training, training and doing exercises related to the state of mindfulness exercises, practicing paying attention to breathing, doing body scan exercises, doing sitting meditation, doing yoga movements, practicing mindful eating, practicing mindful walking meditation, and creating a personal mindfulness plan. Participants are asked to do mindfulness exercises for 45 minutes daily as homework. Number of treatment sessions: 8 sessions, 30 to 60 minutes, once a week, treatment is done individually.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety score on the Spitzer et al. Generalized Anxiety Disorder Questionnaire. Timepoint: Anxiety score was measured using the Spitzer et al. Generalized Anxiety Disorder Questionnaire at the beginning of the study and before the start of the mindfulness-based stress reduction intervention. Method of measurement: Spitzer et al. General Anxiety Inventory.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Sleep quality score. Timepoint: At the beginning and before the intervention begins and at the end after the intervention ends. Method of measurement: Pittsburgh Sleep Quality Questionnaire.</sec_outcome>
      <sec_outcome>Anxiety score. Timepoint: At the beginning and before the intervention begins and at the end after the intervention ends. Method of measurement: Beck anxiety questionnaire.</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>2026-03-17</approval_date>
        <contact_name>کمیته اخلاق دانشگاه آزاد اسلامی واحد تنکابن</contact_name>
        <contact_address>5 kilometers to Tonekabon City - Vali Abad, Tonekabon, Mazandaran, Iran Tonekabon Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
