<?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>IRCT20260609069727N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-06-28</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of acceptance and commitment therapy on the management of psychological symptoms in women with migraine.</public_title>
      <acronym></acronym>
      <scientific_title>Studying the effectiveness of acceptance and commitment therapy on emotional resilience, cognitive avoidance, and rumination in women with migraine.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90913</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The statistical population of the present study will include all female patients with migraine who refer to neurologists at Shafa Hospital in Ahvaz during the specified time period of the study. Purposive sampling method will be used to select the sample. In this way, by referring to the neurology department of Shafa Hospital and obtaining permission from the relevant doctors, a list of patients with migraine will be received. After selecting the samples to a volume of 40 people, based on the inclusion and exclusion criteria of the study, the participants will be randomly assigned to two groups: "Acceptance and Commitment Therapy" (intervention group) and "Waiting List" (control group). Randomization will be performed using random blocks with variable sizes (4 and 6 people) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel software and then placed in opaque, sealed, and numbered envelopes so that the researcher and participants are not aware of the allocation sequence (allocation concealment). Opening the envelope and informing the group allocation will only be done when each participant enters the study. To ensure the equality of the baseline variables (such as anxiety level, age, and headache frequency and severity), their distribution in the two groups will be examined during the statistical analysis stage.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Neurological Migraine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Acceptance and commitment therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: acceptance exercises, cognitive dissociation exercises, presence-in-the-moment exercises, identification of personal values, and committed action exercises. The content of the different sessions is based on the following: Session 1: Pre-test, introduction to the concept of migraine and its relationship with excessive control, Session 2: Focus on the concept of "acceptance" instead of "coping"; teaching how to accept sensory and emotional experiences without trying to eliminate or change them in an avoidant manner. Session 3: Teaching "cognitive dissociation" techniques to reduce the power of rumination and learn how to observe thoughts instead of drowning in them. Session 4: "Presence-in-the-moment" and mindfulness exercises to reduce cognitive avoidance and focus on current experiences instead of worrying about the future or the past. Session 5: Identifying "life values"; helping participants understand what is really important to them in life. Session 6: “Committed Action” exercises; designing small, specific action plans to move toward values, even in the presence of pain or unpleasant thoughts. Session 7: Integrating concepts (self-improvement); teaching how to observe thoughts and feelings from a neutral position and maintain emotional resilience in critical moments. Session 8: Final summary, reviewing coping protocols at home, providing suggestions for maintaining psychological flexibility, administering a post-test, and scheduling a follow-up test.weekly 90-minute group sessions . Intervention 2: Control group: The control group will not receive any intervention during the research, but to prevent factors that threaten the internal validity of the research, such as compensatory competition by the control group or demoralization, they will receive a compassion therapy intervention after data collection.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Due to the failure to start the research work, and consequently, the failure to write the article, which is a requirement for publishing the data, I will publish the data as soon as the aforementioned problems are resolved.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Azin Bekhradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 10, Pasargad 4 Complex, No. 23, Mitra Alley, Melli Rah Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163753687</zip>
        <telephone>+98 61 3444 2015</telephone>
        <email>azin.hb1378@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Azin Bekhradi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Unit 10, Pasargad 4 Complex, No. 23, Mitra Alley, Melli Rah Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6163753687</zip>
        <telephone>+98 61 3444 2015</telephone>
        <email>azin.hb1378@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women with migraine aged 20 to 50 years
A history of headaches during at least the past 6 months</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Participation in other psychotherapy sessions at least one month before the study
Unwillingness to participate in research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Acceptance and commitment therapy. Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Sequence of sessions: twice a week; Therapeutic tools used: acceptance exercises, cognitive dissociation exercises, presence-in-the-moment exercises, identification of personal values, and committed action exercises. The content of the different sessions is based on the following: Session 1: Pre-test, introduction to the concept of migraine and its relationship with excessive control, Session 2: Focus on the concept of "acceptance" instead of "coping"; teaching how to accept sensory and emotional experiences without trying to eliminate or change them in an avoidant manner. Session 3: Teaching "cognitive dissociation" techniques to reduce the power of rumination and learn how to observe thoughts instead of drowning in them. Session 4: "Presence-in-the-moment" and mindfulness exercises to reduce cognitive avoidance and focus on current experiences instead of worrying about the future or the past. Session 5: Identifying "life values"; helping participants understand what is really important to them in life. Session 6: “Committed Action” exercises; designing small, specific action plans to move toward values, even in the presence of pain or unpleasant thoughts. Session 7: Integrating concepts (self-improvement); teaching how to observe thoughts and feelings from a neutral position and maintain emotional resilience in critical moments. Session 8: Final summary, reviewing coping protocols at home, providing suggestions for maintaining psychological flexibility, administering a post-test, and scheduling a follow-up test.weekly 90-minute group sessions .</i_keyword>
      <i_keyword>Control group: The control group will not receive any intervention during the research, but to prevent factors that threaten the internal validity of the research, such as compensatory competition by the control group or demoralization, they will receive a compassion therapy intervention after data collection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotional resilience. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: Measurement will be using the Connor and Davidson Resilience Scale.</prim_outcome>
      <prim_outcome>Cognitive avoidance. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: Measurement will be done using the Cognitive Avoidance Questionnaire.</prim_outcome>
      <prim_outcome>Rumination. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: Measurement will be using the rumination response 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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-04-18</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz Branch</contact_name>
        <contact_address>Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
