<?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>IRCT20250915067256N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effectiveness of Acceptance and Commitment Therapy</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Acceptance and Commitment Therapy on Health Anxiety, Meta‑Worry, Health‑Promoting Lifestyle, and Cognitive Flexibility in Psychosomatic Patients with Migraine</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/86189</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: In this study, to achieve complete random allocation and eliminate any researcher interference or bias, the simple randomization method will be employed. First, a complete list of women attending the counseling center who meet the inclusion criteria will be prepared. Then, each participant will be assigned an initial numerical identification code. These codes will be entered into the Random Number Generator software, which will generate a unique random number for each individual. After generating the numbers, participants will be arranged in ascending order based on their random number values. Subsequently, the first fifteen individuals on the list will be assigned to the experimental group, and participants numbered sixteen to thirty will be assigned to the control group. This process is designed in such a way that neither the order of entry nor the researcher’s prior knowledge of the participants plays any role in allocation, and it will be impossible to predict any participant’s group before the completion of the randomization process.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychosomatic symptoms of migraine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and commitment therapy, as another method derived from the third wave of psychotherapy, has its roots in cognitive behavioral therapy based on contextualism and the theory of mental relations framework and has six basic principles including acceptance, fault-finding, self as context, connection to the present, recognition of values, and committed action (Garcia et al., 2023). The main goal of this therapy is to achieve a more valuable and satisfying life by increasing psychological flexibility. In this study, Forman and Herbert's (2009) model, which was also used in the study by Shirali and Dasht-e-Bozori (2019), will be used for acceptance and commitment therapy. Intervention 2: Control group: They do not receive any intervention or treatment.</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 Participant data is completely confidential and I do not intend to publish it.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hossein Namazi Furoshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6184694880</zip>
        <telephone>+98 930 584 3408</telephone>
        <email>h.namazi.f@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hossein Namazi Furoshani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6184694880</zip>
        <telephone>+98 930 584 3408</telephone>
        <email>h.namazi.f@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Aged 31 to 50 years
Diagnosis of psychosomatic symptoms and migraine in them
Having consent to participate in the research</inclusion_criteria>
      <agemin>31 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Substance addiction
Use of psychiatric medications such as anti-anxiety and antidepressants
Receipt of psychological services within the past three months
History of receiving Acceptance and Commitment Therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Somatization disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and commitment therapy, as another method derived from the third wave of psychotherapy, has its roots in cognitive behavioral therapy based on contextualism and the theory of mental relations framework and has six basic principles including acceptance, fault-finding, self as context, connection to the present, recognition of values, and committed action (Garcia et al., 2023). The main goal of this therapy is to achieve a more valuable and satisfying life by increasing psychological flexibility. In this study, Forman and Herbert's (2009) model, which was also used in the study by Shirali and Dasht-e-Bozori (2019), will be used for acceptance and commitment therapy.</i_keyword>
      <i_keyword>Control group: They do not receive any intervention or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health concern. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Wells and Davis Anxious Thought Scale (1994).</prim_outcome>
      <prim_outcome>Metaconcern. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Wells and Davis Anxious Thought Scale (1994).</prim_outcome>
      <prim_outcome>Health-promoting lifestyle. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Walker, Secrist, and Pender Health Promoting Lifestyle Questionnaire (1987).</prim_outcome>
      <prim_outcome>Cognitive flexibility. Timepoint: before performing the intervention and two weeks after completion of the intervention. Method of measurement: Dennis and Vanderwaal Cognitive Flexibility Questionnaire (2010).</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>2025-07-23</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz</contact_name>
        <contact_address>No. 44, Amir Building, Unit 9, 1st Behdari St., Behind Al-Hadi Mosque, Ariashahr Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
