<?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>IRCT20251210068278N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-02</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Investigating the effect of mindfulness training on feelings of loneliness, psychological well-being, and spiritual experiences</public_title>
      <acronym>AMK</acronym>
      <scientific_title>The effectiveness of mindfulness training on loneliness, psychological well-being, and spiritual experiences of women-headed households</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90303</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, Randomization description: Due to the lack of access to the entire community, they will be selected based on the willingness of individuals and the conditions of participation in the research using the convenience method. Convenience sampling is a method that can select the most accessible individuals for the study. Since it is not possible to have access to the entire community of female head of household, convenience sampling will be used to facilitate the work and be accessible to the community of female head of household of Rasht Welfare. After that, individuals will be selected for the experimental and control groups using a simple random method. Each of them will be given special codes and using a random number table (equal chances), 20 people will be placed in the experimental group and another 20 in the control group.</study_design>
      <phase>3</phase>
      <hc_freetext>focuses on the psycho-social vulnerability of female-headed households.".</hc_freetext>
      <i_freetext>Intervention group: Intervention group: The experimental group will undergo a mindfulness-based training program based on the book Attention Awareness Workbook by John Teasdale, Mark Williams, and Zindel Segal, translated by Dr. Anousheh Aminzadeh, in 8 90-minute sessions (one session per week). In these sessions, the main mindfulness techniques will be taught by Fatemeh Kamrani. The control group will not receive any psychological intervention during this time period..</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is The participants are female heads of households covered by the Welfare Department, and permission to publish the participants has not been granted by the Welfare Department or the participating individuals.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fatemeh Kamrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maskanmehr</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۶۹۵۵۳۸۵</zip>
        <telephone>+98 912 396 5279</telephone>
        <email>fatemekam123@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fatemeh kamrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Maskanmehr</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۴۱۹۶۹۵۵۳۸۵</zip>
        <telephone>+98 21 2232 8397</telephone>
        <email>fatemekam123@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in research
No drug or alcohol addiction
Absence of specific mental and physical problems
Age 20 to 50 years
Age 20 to 50 years</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>UnWillingness to participate in research
Having and addiction
Having a severe physical or mental problem
Age over 60
Illiterate</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: The experimental group will undergo a mindfulness-based training program based on the book Attention Awareness Workbook by John Teasdale, Mark Williams, and Zindel Segal, translated by Dr. Anousheh Aminzadeh, in 8 90-minute sessions (one session per week). In these sessions, the main mindfulness techniques will be taught by Fatemeh Kamrani. The control group will not receive any psychological intervention during this time period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Loneliness is an unpleasant subjective psychological experience arising from an individual's perception of a discrepancy between their desired and actual social relationships (Russell et al., 1984). Timepoint: The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week. Method of measurement: In this study, loneliness is measured by the total score obtained from the Russell, Peplau, and Cortona Loneliness Scale (20-item version). The scores achieved by each participant on this scale serve as the operational indicator of their level of loneliness, with higher scores indicating a greater degree of loneliness.</prim_outcome>
      <prim_outcome>Psychological well-being extends beyond mere happiness or the absence of mental illness. Based on Carol Ryff's (1989) theory, this concept refers to positive functioning and personal growth across six key dimensions: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. This perspective links mental health to the continuous development and realization of an individual's potential. Timepoint: The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week. Method of measurement: In this study, psychological well-being is measured using the total score and subscale scores from the Ryff Scales of Psychological Well-being (18-item short form). The scores achieved by each participant on this scale serve as the operational indicator of their level of psychological well-being, with higher scores indicating a greater degree of well-being.".</prim_outcome>
      <prim_outcome>Spiritual experiences refer to personal subjective and emotional experiences, which include a sense of connection to something greater than oneself (such as God, nature, or the universe), finding meaning and purpose in life, and experiencing feelings of awe, peace, and oneness (Andrewood &amp; Tracy, 2002). Timepoint: The research design is a quasi-experimental pretest-posttest design with a control group. The experimental group will participate in an 8-session mindfulness-based training program, consisting of one 90-minute session per week. Method of measurement: In this study, spiritual experiences are measured by the total score obtained from the Daily Spiritual Experience Scale (DSE) by Andrewood and Tracy (16-item version). The score achieved by each participant on this scale serves as the operational indicator of the extent and frequency of their spiritual experiences. Higher scores indicate more frequent and intense spiritual experiences.</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>Welfare of Gilan Province</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-05-23</approval_date>
        <contact_name>Ethics committee of Tonekabon Azad University of Medical Sciences</contact_name>
        <contact_address>Maskanmehr Rasht Guilan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
