<?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>IRCT20260504069259N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-07-04</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of semantic therapy based on Rumi's thoughts and mindfulness-based stress reduction on caregiving pressure in family caregivers of the elderly</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the effectiveness of semantic therapy based on Rumi's thoughts and mindfulness-based stress reduction on caregiving pressure in family caregivers of the elderly</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90922</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: En The sample size in the G*Power program, version 1.3 (Faul et al., 2019), with a confidence level of 0.95, a power of 0.80, and a dropout rate of 10%, was calculated for each group of 15 people. Therefore, 45 people were selected based on the inclusion criteria and by exclusion using the purposive sampling method and will be divided into two experimental groups and a control group (each group 15 people). The first experimental group will receive meaning therapy based on Rumi's thoughts in 8 75-minute sessions, and the second experimental group will receive mindfulness-based stress reduction in 8 60-minute sessions (2 sessions per week). During this period, the control group will not receive any intervention.</study_design>
      <phase>3</phase>
      <hc_freetext>Caregiving pressure.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  The semantic therapy intervention based on Rumi's thoughts will be implemented in groups in 8 75-minute sessions (two sessions per week, for four weeks) for family caregivers of the elderly. The sessions will be held by an assistant professor of psychology and a scientifically qualified therapist in the Mehr Nursing Home in Sari. The content of the intervention is based on the principles of semantic therapy using the mystical and anthropological concepts of Rumi Jalaluddin Mohammad Balkhi's thoughts and includes training, group discussion, interpretation and analysis of stories and parables from the Masnavi, reflection on personal experiences, reflective exercises, and homework assignments. The main themes of the sessions include understanding the meaning of life and the human position, self-knowledge, self-control, acceptance of aging, making meaning in suffering, remembrance and meditation, facing death anxiety, love, patience, resilience, and gratitude. At the end of each session, homework is given in accordance with the content taught, and at the beginning of the next session, feedback is reviewed and provided. During each session, about 15 to 20 minutes are allotted for participants to rest and receive refreshments. No drugs, consumables, or medical devices are used in this intervention, and the intervention is based solely on group education and psychological techniques. Intervention 2: Intervention group:The mindfulness-based stress reduction intervention will be implemented as a group and based on the standard Mindfulness-Based Stress Reduction program adapted from Segal et al.'s (2016) program, in 8 60-minute sessions (two sessions per week, for four weeks) for family caregivers of the elderly. The sessions will be held by an assistant professor of psychology and a qualified therapist in the environment of Mehr nursing home in Sari city. The content of the intervention includes teaching the concepts of mindfulness, performing formal and informal mindfulness exercises, body inspection, conscious breathing, sitting meditation, walking meditation, conscious eating, simple stretching movements and gentle yoga, compassion meditation, and exercises to increase awareness of thoughts, emotions, bodily sensations, and environmental stimuli. Also, in each session, review of home exercises, group discussion, providing feedback and teaching practical strategies to manage stress and increase presence of mind are done. At the end of each session, homework is presented according to the content of the session for daily practice and reviewed in the next session. No drugs, chemicals, medical equipment or invasive methods are used in this intervention, and the intervention is based solely on psychological and behavioral training and exercises. Intervention 3: Control group: Does not receive any intervention.</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:
Can be shared with individuals unidentifiable

When:
Since the winter of 2026

To whom:
Researchers, industries and nursing homes

Conditions:
Researchers - industries and nursing homes have the ability to use the data. In fact, they have the ability to use the results of the data to help family caregivers. Researchers have the ability to use it for review and referencing articles.

Where to obtain:
fateme.qolian70@gmail.com Email Fatemeh Qolian Nozari and respond as soon as possible.

How to obtain:
Please send your request to the provided email address; a response will be given as soon as possible, within one week.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr seyed Hamze Hoseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Razi Street, Imam Sari Hospital, Psychiatric Department</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4817718743</zip>
        <telephone>0098 33361700</telephone>
        <email>Hosseini.sh20@gmail.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Asghar Norouzi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Reza Blvd., Imam Reza 6</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4841683648</zip>
        <telephone>0098 33032891</telephone>
        <email>asgarnoruzi@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No use of psychiatric medications
No use psychological treatmentsduring the study based on clinical
interviewInformed consent to participate in research
Minimum education: Diploma</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></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>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  The semantic therapy intervention based on Rumi's thoughts will be implemented in groups in 8 75-minute sessions (two sessions per week, for four weeks) for family caregivers of the elderly. The sessions will be held by an assistant professor of psychology and a scientifically qualified therapist in the Mehr Nursing Home in Sari. The content of the intervention is based on the principles of semantic therapy using the mystical and anthropological concepts of Rumi Jalaluddin Mohammad Balkhi's thoughts and includes training, group discussion, interpretation and analysis of stories and parables from the Masnavi, reflection on personal experiences, reflective exercises, and homework assignments. The main themes of the sessions include understanding the meaning of life and the human position, self-knowledge, self-control, acceptance of aging, making meaning in suffering, remembrance and meditation, facing death anxiety, love, patience, resilience, and gratitude. At the end of each session, homework is given in accordance with the content taught, and at the beginning of the next session, feedback is reviewed and provided. During each session, about 15 to 20 minutes are allotted for participants to rest and receive refreshments. No drugs, consumables, or medical devices are used in this intervention, and the intervention is based solely on group education and psychological techniques.</i_keyword>
      <i_keyword>Intervention group:The mindfulness-based stress reduction intervention will be implemented as a group and based on the standard Mindfulness-Based Stress Reduction program adapted from Segal et al.'s (2016) program, in 8 60-minute sessions (two sessions per week, for four weeks) for family caregivers of the elderly. The sessions will be held by an assistant professor of psychology and a qualified therapist in the environment of Mehr nursing home in Sari city. The content of the intervention includes teaching the concepts of mindfulness, performing formal and informal mindfulness exercises, body inspection, conscious breathing, sitting meditation, walking meditation, conscious eating, simple stretching movements and gentle yoga, compassion meditation, and exercises to increase awareness of thoughts, emotions, bodily sensations, and environmental stimuli. Also, in each session, review of home exercises, group discussion, providing feedback and teaching practical strategies to manage stress and increase presence of mind are done. At the end of each session, homework is presented according to the content of the session for daily practice and reviewed in the next session. No drugs, chemicals, medical equipment or invasive methods are used in this intervention, and the intervention is based solely on psychological and behavioral training and exercises.</i_keyword>
      <i_keyword>Control group: Does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score obtained from the care pressure questionnaire of Zarit et al. (1980). Timepoint: Before the intervention, after the intervention, and two months after the intervention. Method of measurement: The score obtained from the care pressure questionnaire of Zarit et al. (1980).</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>2025-07-19</approval_date>
        <contact_name>Ethics Committee in Biomedical Research</contact_name>
        <contact_address>Imam Reza Blvd., Imam Reza 6, Saray Mehr sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
