<?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>IRCT20240217061032N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-04-25</date_registration>
      <primary_sponsor>University of Mohaghegh Ardabili</primary_sponsor>
      <public_title>Effectiveness of Compassion-Focused Acceptance and Commitment Therapy in Patients With Multiple Sclerosis</public_title>
      <acronym>CFACT for MS</acronym>
      <scientific_title>The effectiveness of Compassion-focused Acceptance and Commitment Therapy on Experiential avoidance, Self-care, Pain self-efficacy and pain catastrophizing in Patients with Multiple Sclerosis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75543</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study follows a basic design and is of the experimental type with a pretest-posttest control group design. There were two groups in this study: experimental and control. Pretests were administered to both the experimental and control groups, after which the experimental group received a psychological intervention, while the control group simply remained on the waiting list. Finally, posttests were administered to both groups, Randomization description: Volunteers to participate in the project were divided into two random groups, experimental and control, using the rand function of Excel software, using a simple randomization method. Concealment was not used and we only used the experimental and control groups to evaluate the applied psychological intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Multiple Sclerosis.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: receiving 10 sessions of one and a half hours of  on Compassion Focused Acceptance and Commitment Therapy, taken from the book Compassion-focused therapy for ACT therapists by Dennis Tirch. Intervention 2: Control group: did not receive any treatment and were only on the waiting list.</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:
Documents will be made available to references without mentioning their names upon request.

When:
The access period starts 6 months after the results are published.

To whom:
University professors and researchers.

Conditions:
If used to get ideas and do similar designs

Where to obtain:
Apply to my university email

How to obtain:
The request of the person who wishes will be applied after checking the conditions during 1 week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mehdi Ebrahimpour Azizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>12 Tawheed Alley, Sharifi Boulevard, Babolsar, Mazandaran, Iran</address>
        <city>Babolsar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4741756476</zip>
        <telephone>+98 11 3533 8953</telephone>
        <email>mehdii.ebrahimpour@gmail.com</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nader Hajloo</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Mohaghegh Ardabili, Daneshgah Street, Ardabil , Iran</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۱۳۶۷ - ۵۶۱۹۹</zip>
        <telephone>+98 45 3150 0000</telephone>
        <email>hajloo53@uma.ac.ir</email>
        <affiliation>University of Mohaghegh Ardabili</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Be diagnosed with MS based on the diagnosis of a neurologist
More than a month has passed since the diagnosis of MS
Literacy level higher than cycle
Be between the ages of 18 and 61
Willingness and informed consent to participate in the research project
Expansion Disability status score (EDSS) between 0 and 5</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>61 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having a history of serious mental illness (psychotic) and a history of hospitalization in a mental hospital
Drug addiction
Lack of informed consent to participate in the research project</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>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: receiving 10 sessions of one and a half hours of  on Compassion Focused Acceptance and Commitment Therapy, taken from the book Compassion-focused therapy for ACT therapists by Dennis Tirch.</i_keyword>
      <i_keyword>Control group: did not receive any treatment and were only on the waiting list</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Expanded Disability Status Scale (EDSS). Timepoint: Before the start of the intervention - after the start of the intervention. Method of measurement: Medical examination.</prim_outcome>
      <prim_outcome>AAQ-II. Timepoint: Before the start of the intervention - after the start of the intervention. Method of measurement: Questionnaire.</prim_outcome>
      <prim_outcome>Self-care questionnaire by Morvati Sharif Abad et al. Timepoint: Before the start of the intervention - after the start of the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Pain self-efficacy questionnaire (Nicolas, 2007). Timepoint: Before the start of the intervention - after the start of the intervention. Method of measurement: questionnaire.</prim_outcome>
      <prim_outcome>Pain Catastrophizing Scale (PCS). Timepoint: Before the start of the intervention - after the start of the intervention. Method of measurement: questionnaire.</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 Mohaghegh Ardabili</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-26</approval_date>
        <contact_name>Ethics committee of Mohaghegh University</contact_name>
        <contact_address>University of Mohaghegh Ardabili, Daneshgah Street, Ardabil , Iran Ardabil Ardabil Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
