<?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>IRCT20200514047442N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-06</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headache</public_title>
      <acronym></acronym>
      <scientific_title>Comparison the Effectiveness of Mindfulness Based Cognitive therapy with Cognitive Behavioral therapy Focused on Isomnia and Fordyce Happiness training on Depression, Pain Self Efficacy. Pain Anxiety, , Resiliency, Affective Capital and Migraine Symptoms in Women with Migraine Headache.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-01-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>72</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60016</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants in the study are divided into 4 groups of 18 people and randomly assigned to 3 intervention and control groups.Reminds about how to randomize afterInitial interview and initial screening, 72 women with the criteria to enter the study were selected, then by coding and using the lottery method, 18 people are divided into four groups by the lottery method into three experimental groups based on type The intervention and a control group are divided, Blinding description: The data analyzer does not know the type of actions for the groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>migrain.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Cognitive Behavioral therapy Focused on Isomnia. Intervention 2: Intervention group: Mindfulness Based Cognitive therapy. Intervention 3: Intervention group: Fordyce Happiness training. Intervention 4: Control group: not intervention.</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 results of the analysis of participants' individual data are shared

When:
20.4.2022-208.2022

To whom:
All researchers

Conditions:
In order to use the results of the analysis in future research

Where to obtain:
From the site of the journals in which the extracted article is published

How to obtain:
If the article is published in scientific research journals, the author's email address will be posted on the site and researchers can request the necessary information by sending a request to the author's email address. After reviewing the requests by the author, if approved, the authorized information will be sent to researchers

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Aida Elham</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>SHAHID BEHESHTI STREET</address>
        <city>kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8163867691</zip>
        <telephone>+98 34 3211 3883</telephone>
        <email>afsane.sartipzade@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohsen Golparvar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Arghavanieh Street</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8155139998</zip>
        <telephone>0319-35354001</telephone>
        <email>drmgolparvar@hotmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of migraine by a neurologist, Being in the age group of 18 to 55 Female gender, a minimum of secondary education,Not undergoing parallel psychological or psychiatric treatments, Having physical fitness (not having debilitating physical diseases such as MS, muscular and skeletal diseases) to participate in training courses,Determination and desire to participate in research and its continuation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>No migraine diagnosed by a neurologist,Being under the age of 18 and over 55..</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Cognitive Behavioral therapy Focused on Isomnia</i_keyword>
      <i_keyword>Intervention group: Mindfulness Based Cognitive therapy</i_keyword>
      <i_keyword>Intervention group: Fordyce Happiness training</i_keyword>
      <i_keyword>Control group: not intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain Anxiety. Timepoint: pretest-posttest- two months follow up. Method of measurement: Pain Anxiety scale.</prim_outcome>
      <prim_outcome>Pain Self Efficacy. Timepoint: pretest-posttest- two months follow up. Method of measurement: Pain Self Efficacy scale.</prim_outcome>
      <prim_outcome>Depression. Timepoint: pretest-posttest- two months follow up. Method of measurement: Beck Depression scale.</prim_outcome>
      <prim_outcome>Resiliency. Timepoint: pretest-posttest- two months follow up. Method of measurement: Conner-Davidson resiliency scale.</prim_outcome>
      <prim_outcome>Affective Capital. Timepoint: pretest-posttest- two months follow up. Method of measurement: Affective Capital scale.</prim_outcome>
      <prim_outcome>Migraine Symptoms. Timepoint: pretest-posttest- two months follow up. Method of measurement: Migraine Symptoms scale.</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>-</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-02</approval_date>
        <contact_name>IRAN NATION COMMITEE FOR ETICS IN BIOMEDICAL RESEARCH</contact_name>
        <contact_address>kerman kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
