<?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>IRCT20251129068145N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-01</date_registration>
      <primary_sponsor>University of Isfahan</primary_sponsor>
      <public_title>Effectiveness of Spiritual Therapy Intervention on Meaning in Life, Quality of Life, and Hope for Life in Women with Multiple Sclerosis</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Spiritual Therapy Intervention on Meaning in Life, Quality of Life, and Hope for Life in Women with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93470</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>Women with multiple sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in the intervention group will receive a structured, group-based spirituality therapy program consisting of eight weekly 90-minute sessions. The sessions will be conducted by a trained therapist and will include psychoeducation, guided discussion, experiential exercises, feedback, and homework assignments. The intervention will address spirituality, self-awareness, awareness of God’s presence, prayer and spiritual practices, hope and reliance on God, spiritual beliefs, interpersonal relationships, generosity, meaning in suffering, patience, self-transcendence, and personal responsibility. The first session will focus on establishing therapeutic conditions, introducing the rationale and objectives of the intervention, building group interaction, identifying participants’ concerns, and developing a therapeutic contract. Subsequent sessions will address spirituality education and practice, self-knowledge and personal responsibility, prayer and communication with God, hope and reliance on God, remembrance and spiritual practices, spiritual beliefs and their relationship with well-being and social relationships, generosity and giving and receiving love and respect, and finally the meaning of suffering, patience, self-transcendence, and responsibility toward oneself and others. Participants will be encouraged to practice the discussed concepts between sessions through assigned homework and reflective exercises. At the end of the program, participants will be evaluated and scheduled for follow-up assessment. Intervention 2: Control group: Participants in the control group will not receive the spirituality therapy intervention during the study period and will continue their usual care and routine activities. They will receive the same outcome assessments as the intervention group at the scheduled measurement points, including baseline and post-intervention assessments and follow-up. No additional therapeutic sessions or spirituality-based training will be provided to this group during the study 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>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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohammad Bagher Kajbaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 5458</telephone>
        <email>m.b.kaj@edu.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohammad Bagher Kajbaf</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square, Isfahan, Iran.</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۸۱۷۴۶۷۳۴۴۱</zip>
        <telephone>+98 31 3793 5458</telephone>
        <email>m.b.kaj@edu.ui.ac.ir</email>
        <affiliation>University of Isfahan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 20–50 years.
Minimum educational level of a high school diploma.
Willingness to participate and provision of written informed consent.
Absence of severe concurrent physical or mental illness.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in the intervention group will receive a structured, group-based spirituality therapy program consisting of eight weekly 90-minute sessions. The sessions will be conducted by a trained therapist and will include psychoeducation, guided discussion, experiential exercises, feedback, and homework assignments. The intervention will address spirituality, self-awareness, awareness of God’s presence, prayer and spiritual practices, hope and reliance on God, spiritual beliefs, interpersonal relationships, generosity, meaning in suffering, patience, self-transcendence, and personal responsibility. The first session will focus on establishing therapeutic conditions, introducing the rationale and objectives of the intervention, building group interaction, identifying participants’ concerns, and developing a therapeutic contract. Subsequent sessions will address spirituality education and practice, self-knowledge and personal responsibility, prayer and communication with God, hope and reliance on God, remembrance and spiritual practices, spiritual beliefs and their relationship with well-being and social relationships, generosity and giving and receiving love and respect, and finally the meaning of suffering, patience, self-transcendence, and responsibility toward oneself and others. Participants will be encouraged to practice the discussed concepts between sessions through assigned homework and reflective exercises. At the end of the program, participants will be evaluated and scheduled for follow-up assessment.</i_keyword>
      <i_keyword>Control group: Participants in the control group will not receive the spirituality therapy intervention during the study period and will continue their usual care and routine activities. They will receive the same outcome assessments as the intervention group at the scheduled measurement points, including baseline and post-intervention assessments and follow-up. No additional therapeutic sessions or spirituality-based training will be provided to this group during the study period.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Meaning in Life. Timepoint: Meaning in life will be assessed at baseline (pre-tst), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up). Method of measurement: Meaning in life will be assessed using the 10-item Meaning in Life Questionnaire developed by Steger and Frazier. Each item is rated on a 7-point Likert scale ranging from 1 (absolutely untrue) to 7 (absolutely true). Item 9 is reverse-scored. The total score will be calculated by summing the relevant item scores, with higher scores indicating a greater perceived meaning in life.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Quality of Life will be assessed at baseline (pre-test), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up). Method of measurement: Quality of life will be assessed using the 29-item multiple sclerosis impact scale (MSIS-29) questionnaire. The first 20 items assess the physical impact of multiple sclerosis, while the remaining 9 items assess its psychological impact. Each item is rated on a 5-point response scale scored from 1 to 5. Total scores range from 29 to 145, with higher scores indicating a greater impact of MS and, consequently, poorer quality of life.</prim_outcome>
      <prim_outcome>Hope for Life. Timepoint: Hope for life will be assessed at baseline (pre-test), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up). Method of measurement: Hope will be assessed using the 12-item Hope Scale. Each item is rated on a 5-point Likert scale from 1 (very low) to 5 (very high). The scale assesses two dimensions of hope: agency thinking and pathway thinking. Four items are distractors and are excluded from scoring. The total score will be calculated based on the eight scored items, with higher scores indicating greater levels of hope.</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>University of Isfahan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-02-21</approval_date>
        <contact_name>Research Ethics Committee of the University of Isfahan</contact_name>
        <contact_address>Office of the Vice-Chancellor for Research and Technology, Research Misconduct Review Committee, University of Isfahan, Azadi Square, Isfahan, Iran. Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
