<?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>IRCT20250129064562N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-04-23</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Tele-mindfullness for family caregivers of individuals with Alzheimer</public_title>
      <acronym></acronym>
      <scientific_title>Impact of tele-mindfullness education on resiliance and life satisfaction of family caregivers of individuals with Alzheimer</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81835</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: To maintain consistent research environment conditions between the control and experimental groups, the random allocation of samples into the control and intervention groups will be performed in an alternating manner. For the assignment of the first sample, a coin toss will be employed to determine placement in either the control or intervention group. Subsequent samples will be alternately allocated to the corresponding groups. Sampling will continue until the required sample size, as determined by the specified formula, is achieved, Blinding description: In this study, data analysts are blinded to the placement of caregivers in the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Caregiving for individual with Alzheimer's disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The educational content for the intervention group is designed to provide mindfulness training for family caregivers of individuals with Alzheimer's disease. The training will be delivered over eight 30-minute sessions, conducted twice weekly over four weeks. Session topics include an introduction to mindfulness and mindful raisin eating (Session 1), mindful breathing (Session 2), mindful body scanning (Session 3), mindful seeing and listening (Session 4), mindful walking (Session 5), mindful sitting (Session 6), mindful compassion (Session 7), and a concluding session (Session 8). Additionally, participant experiences will be discussed throughout the sessions. Intervention 2: Control group: After completing the study and analyzing the data, to maintain ethical principles, electronic pamphlets on mindfulness training (which were sent to the intervention group at the end of each session) will be provided to the control group (sent electronically to their respective groups). The researcher will also answer their questions.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is The decision will be made according to the opinion of the ethics commite university and the supervisor.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Raziye Sadat Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 6074</telephone>
        <email>Ra.Hosseiny@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Raziye Sadat Hosseini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1449614535</zip>
        <telephone>+98 21 8670 6574</telephone>
        <email>Ra.Hosseiny@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age of 18 years old or above
Caregiver of a person with Alzheimer's
Family member of the patient
Must possess effective communication skills in Persian
Must provide direct daily care for a minimum of four hours</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having informed consent for participation in the research study
Not Having enough proficiency in using a smartphone or tablet for messaging, attending classes, and downloading files
Not owning a smartphone and have reliable internet access for participation in online sessions
Having a history of substance or medication abuse
Having a recently diagnosed psychiatric disorder such as severe depression, anxiety disorder, or psychosis
Engaging in a regular mindfulness meditation, mindful yoga, or enrolled in a similar mindfulness-based program</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G30</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Alzheimer's disease</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 educational content for the intervention group is designed to provide mindfulness training for family caregivers of individuals with Alzheimer's disease. The training will be delivered over eight 30-minute sessions, conducted twice weekly over four weeks. Session topics include an introduction to mindfulness and mindful raisin eating (Session 1), mindful breathing (Session 2), mindful body scanning (Session 3), mindful seeing and listening (Session 4), mindful walking (Session 5), mindful sitting (Session 6), mindful compassion (Session 7), and a concluding session (Session 8). Additionally, participant experiences will be discussed throughout the sessions.</i_keyword>
      <i_keyword>Control group: After completing the study and analyzing the data, to maintain ethical principles, electronic pamphlets on mindfulness training (which were sent to the intervention group at the end of each session) will be provided to the control group (sent electronically to their respective groups). The researcher will also answer their questions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The score of resilience. Timepoint: ‌Before and after the intervention. Method of measurement: Resilience Questionnaire for In-home Caregivers of the Elderly.</prim_outcome>
      <prim_outcome>Life Satisfaction Score. Timepoint: Before and after the intervention. Method of measurement: Satisfaction with life scale (SWLS).</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-08-13</approval_date>
        <contact_name>The Research Ethics Working Group of the Vice-Chancellor for Research and Technology at Iran Univers</contact_name>
        <contact_address>Deputy for Research and Technology, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
