<?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>IRCT20220517054892N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-08</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparision ( ACT) &amp; (CFT) on psychological values in migraine</public_title>
      <acronym>(ACT) (CFT)</acronym>
      <scientific_title>Comparison of the effectiveness of acceptance and commitment therapy (ACT) with compassion-focused therapy on emotion regulation, anxiety tolerance and flexibility in women with migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-03-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>108</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64071</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: Randomization will be such that 108 cards are prepared and in 36 of the cards the letter A (for the treatment group focused on acceptance and commitment), in 36 cases the letter B (for the treatment group focused on compassion) and in 36 cases the letter C (for the control group) will be recorded. Subjects will appear at a certain time in a place prepared for this purpose in advance, and each person will be randomly assigned to the group registered inside the card by picking a card that will be placed inside a sealed envelope.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Control group: does not receive any training or intervention. Intervention 2: Compassion-focused therapy: In group sessions (8 sessions, each session for an hour and a half) will teach about the concepts of compassion-focused therapy. These concepts will be taught and discussed in the context of structured group therapy sessions. Intervention 3: Acceptance and Commitment Therapy: In group sessions (8 sessions, each session for one and a half hours), the concepts of therapy based on acceptance and commitment will be taught. These concepts will be taught and discussed in the context of structured group therapy sessions.</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:
The information about the pre-test and post-test of the participants will be published after the end of the study.

When:
The data access period will start six months after the end of the study

To whom:
Researchers working in academic and scientific institutions

Conditions:
Researchers who need data to conduct research under common scientific and humanitarian ethical standards can submit their request by email.

Where to obtain:
You should send your request to these two emails. fv.foroughi@gmail.com and Gholamzadeh.m723@gmail.com

How to obtain:
The researcher sends her request in writing to the mentioned two emails and within ten days, her request will be reviewed and if approved, the data will be sent to her.(feminine)

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam gholamzade jefre</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azad University, Farhangshahr Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۴۹۳۷۳۳۳</zip>
        <telephone>۰۰۹۸ ۳۳ ۳۴۸۴۲۰</telephone>
        <email>Gholamzadeh.m723@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farima Foroughi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19, East 9 Street, Kianpars Blvd</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۵۵۹۵۴۳۹۴</zip>
        <telephone>+98 61 3338 7064</telephone>
        <email>fv.foroughi@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Migraine disease with the diagnosis of a specialist doctor. Having a minimum education of a diploma to do homework, and age range of 20-50 years.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The main conditions of not entering the study before randomization:Having a head injury or injury, participating in educational workshops related to acceptance and commitment therapy and compassion-based therapy outside of therapy sessions, not cooperating with the therapist, suffering from severe medical mental disorders as diagnosed by a psychological specialist through a diagnostic interview, Having dependence or substance abuse, and the absence of evidence based on the existence of a serious and chronic physical illness that requires treatment</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.909</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine, unspecified, not intractable, without status migrainosus</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>N/A</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: does not receive any training or intervention.</i_keyword>
      <i_keyword>Compassion-focused therapy: In group sessions (8 sessions, each session for an hour and a half) will teach about the concepts of compassion-focused therapy. These concepts will be taught and discussed in the context of structured group therapy sessions.</i_keyword>
      <i_keyword>Acceptance and Commitment Therapy: In group sessions (8 sessions, each session for one and a half hours), the concepts of therapy based on acceptance and commitment will be taught. These concepts will be taught and discussed in the context of structured group therapy sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Psychological flexibility: The score obtained from the 20-question questionnaire of Dennis and Vanderwaal (2011). Timepoint: At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention. Method of measurement: Dennis and Vanderwal psychological flexibility questionnaire.</prim_outcome>
      <prim_outcome>Distress tolerance: The score obtained from the 15-question questionnaire of Simon and Gaher's Distress Tolerance Questionnaire. Timepoint: At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention. Method of measurement: Simon and Gaher Distress Tolerance Scale.</prim_outcome>
      <prim_outcome>Emotional regulation: The score obtained from the 36-question emotional regulation questionnaire of Garnevsky et al. (2002). Timepoint: At the beginning of the study (before the start of the intervention), immediately after the intervention and one month after the intervention. Method of measurement: Garnevsky cognitive emotion regulation 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-08</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz branch</contact_name>
        <contact_address>Azad University, Farhangshahr Blvd Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
