<?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>IRCT20221128056653N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-05-12</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparing the effectiveness of compassion-focused therapy with acceptance and commitment-based therapy on marital satisfaction and experiential avoidance.</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of group Therapy based on Compassion-Focused Therapy (CFT) with Acceptance and Commitment-based Therapy (ACT) on Marital Satisfaction and Experiential Avoidance of married patients with relapsing and recovering multiple sclerosis.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/67114</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Multiple sclerosis(MS). Condition 2: Marital satisfaction. Condition 3: Experiential avoidance.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group is a group that experiences eight sessions of group psychotherapy with an interval of one week in the method of focused compassion therapy.This method of psychotherapy helps clients by creating or increasing a relationship of inner compassion with themselves, instead of blaming, condemning or self-criticizing. Self-compassion has been defined as a three-component construct, including self-kindness versus self-judgment, human commonality versus isolation, and mindfulness versus extreme identification. Also, self-compassion is considered in the sense of caring for oneself against self-judgment, human commonality against isolation, and mindfulness against identification. Therefore, this research is trying to help the acceptance and adaption to the current conditions of married people with MS disease, to use the focused treatment of compassion in a group and to measure their effectiveness on two psychological components that are very effective on mental health and recovery. examine the marital relationship, including experiential avoidance and marital satisfaction. Intervention 2: The second intervention group is a group that experiences eight sessions of group psychotherapy with an interval of one week in the method of treatment based on acceptance and commitment.The goal of treatment based on commitment and acceptance is to help people to create a rich, complete and meaningful life, while accepting the suffering that life inevitably brings with it. Pain, whether physical or emotional, is a universal phenomenon. Although pain may be perceived as unpleasant, what leads to real suffering is the struggle to escape or avoid pain. This assumption is the core and basis of treatment based on acceptance and commitment. Therefore, this research is trying to help accept and adapt to the current conditions of married people with MS disease, to apply therapy based on commitment and acceptance as a group and to measure their effectiveness on two psychological components that have a great impact on health. examine the psychological and healing of the marital relationship, including experiential avoidance and marital satisfaction. Intervention 3: The control group is a group that does not experience any type of individual or group psychotherapy.Only at the same time as the intervention groups, at the beginning of the group psychotherapy sessions and at the end of the group psychotherapy sessions, they answer the questionnaires of marital necessity and experiential avoidance.</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 Because the important result of this research is that it will be published in the form of an article after completion.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Negar Asgharipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, Horre ameli St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9195983134</zip>
        <telephone>+98 51 3711 2701</telephone>
        <email>ISH.IT@MUMS.AC.IR</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Negar Asgharipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khorasan Razavi, Mashhad, Horre ameli St</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9195983134</zip>
        <telephone>+98 51 3711 2701</telephone>
        <email>ISH.IT@MUMS.AC.IR</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>At least one month has passed since MS as diagnosed by a specialist doctor.
Being married</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Abuse of drugs, alcohol and psychedelics
Currently doing counseling and psychotherapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G35</hc_code>
      <hc_code></hc_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Multiple sclerosis</hc_keyword>
      <hc_keyword></hc_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group is a group that experiences eight sessions of group psychotherapy with an interval of one week in the method of focused compassion therapy.This method of psychotherapy helps clients by creating or increasing a relationship of inner compassion with themselves, instead of blaming, condemning or self-criticizing. Self-compassion has been defined as a three-component construct, including self-kindness versus self-judgment, human commonality versus isolation, and mindfulness versus extreme identification. Also, self-compassion is considered in the sense of caring for oneself against self-judgment, human commonality against isolation, and mindfulness against identification. Therefore, this research is trying to help the acceptance and adaption to the current conditions of married people with MS disease, to use the focused treatment of compassion in a group and to measure their effectiveness on two psychological components that are very effective on mental health and recovery. examine the marital relationship, including experiential avoidance and marital satisfaction</i_keyword>
      <i_keyword>The second intervention group is a group that experiences eight sessions of group psychotherapy with an interval of one week in the method of treatment based on acceptance and commitment.The goal of treatment based on commitment and acceptance is to help people to create a rich, complete and meaningful life, while accepting the suffering that life inevitably brings with it. Pain, whether physical or emotional, is a universal phenomenon. Although pain may be perceived as unpleasant, what leads to real suffering is the struggle to escape or avoid pain. This assumption is the core and basis of treatment based on acceptance and commitment. Therefore, this research is trying to help accept and adapt to the current conditions of married people with MS disease, to apply therapy based on commitment and acceptance as a group and to measure their effectiveness on two psychological components that have a great impact on health. examine the psychological and healing of the marital relationship, including experiential avoidance and marital satisfaction.</i_keyword>
      <i_keyword>The control group is a group that does not experience any type of individual or group psychotherapy.Only at the same time as the intervention groups, at the beginning of the group psychotherapy sessions and at the end of the group psychotherapy sessions, they answer the questionnaires of marital necessity and experiential avoidance.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Marital satisfaction score in Enrich Marital Satisfaction Questionnaire. Timepoint: Before starting group therapy sessions and after finishing the sessions. Method of measurement: Enrich Marital Satisfaction Questionnaire.</prim_outcome>
      <prim_outcome>Experiential avoidance score in Acceptance and Action Questionnaire, second edition. Timepoint: Before starting group therapy sessions and after finishing the sessions. Method of measurement: Acceptance and Action Questionnaire, second version.</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>2022-11-02</approval_date>
        <contact_name>Ethics Committee in Research Faculty of Medicine, Islamic Azad University - Mashhad Medical Sciences</contact_name>
        <contact_address>14 Imam Khomeini Street, Mashhad, Dr. Shahin Far Medical School Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
