<?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>IRCT20251024067743N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-11-12</date_registration>
      <primary_sponsor>The Lorestan University</primary_sponsor>
      <public_title>Comparing the effects of several psychotherapy models on migraine</public_title>
      <acronym></acronym>
      <scientific_title>Psychological interventions for migraine: A Randomized Controlled Trial Comparing the Efficacy of Intensive Short-Term Dynamic Psychotherapy, Modified Schema Therapy, and Acceptance and Commitment Therapy on Rumination, Experiential Avoidance, Pain severity and Quality of Life in Migraine Patients.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/87082</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sample size is 60 people based on the type of research, which is randomly selected through a lottery and assigned to four groups of 15 people, taking into account dropout. According to experts, the ideal number of members in the treatment groups is up to 12 people (Berg, Landreth, &amp; Fall, 2013), but considering the possibility of dropout, dealing with outliers, and trying to have larger groups to establish homogeneity of variance, each group is 15 people. The sampling method is as follows: by referring to the Psychiatry and Psychology Clinic in Hamedan, a list of all people eligible to participate in the research is prepared with the guidance of the technical manager or the clinic receptionist; after reviewing and having the entry criteria, the first 15 people are assigned to the short-term dynamic therapy group, the second 15 people to the schema therapy group, the third 15 people to the acceptance and commitment therapy group, and the last 15 people to the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>migraine.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: A group that has been affected by short-term intensive dynamic psychotherapy. Intervention group: The group that has been affected by short-term intensive dynamic psychotherapy. Modified short-term psychodynamic psychotherapy is a therapeutic approach that is based on investigating and discovering the underlying causes of mental disorders and creating lasting changes in the patient's thought and behavioral patterns. This treatment method is usually carried out for a limited period of time (several months to a year) and the patient plays an active role in this process. In this study, a 15-session protocol based on the Duvanlu short-term intensive dynamic psychotherapy protocol will be used. Intervention 2: Intervention group:  A group affected by acceptance and commitment therapy.Acceptance and Commitment Therapy is a branch of clinical behavior analysis. It is an empirically based psychological intervention that uses acceptance and mindfulness strategies along with commitment and behavior change strategies to increase psychological flexibility (Hayes et al., 2006). This study will use the 8-session Acceptance and Commitment Therapy protocol (Wells &amp; Sorrell, 2002). Intervention 3: Intervention group: A group affected by schema therapy. Schema therapy was developed by Jeffrey Young for use in the treatment of personality disorders and chronic disorders. The goal of schema therapy is to help patients meet their basic emotional needs through the treatment of schemas, by reducing the intensity of emotional memories including the schema and the intensity of physical sensations, and by changing the cognitive patterns associated with the schema (Young, 2006; Klasko, Wishar, 2006). In this study, a 10-session protocol based on group schema therapy (Young et al., 2003) will be used. Intervention 4: Control group: Group not affected by any 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All data is potentially shareable after de-identifying individuals.

When:
Access period starts 6 months after results are published.

To whom:
It will be available only to researchers working in academic and scientific institutions.

Conditions:
In order to observe and conduct similar research

Where to obtain:
To Mohammad Sina Hanifi's email address: MSINAH92@GMAIL.COM

How to obtain:
Send a message to the above email six months after the results are published and I will respond to you within two business days.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohamad Sina Hanifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 7 12 Metri Sangshir</address>
        <city>HAMEDAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6516774764</zip>
        <telephone>+98 81 3826 5219</telephone>
        <email>msinah92@gmail.com</email>
        <affiliation>The Lorestan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Sina Hanifi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>NO 7 12 Metri Sangshir</address>
        <city>HAMEDAN</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6515774764</zip>
        <telephone>+98 81 3826 5219</telephone>
        <email>msinah92@gmail.com</email>
        <affiliation>The Lorestan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients with migraine disorder No history of drug use
No history of alcohol consumption
No history of severe mental disorders such as hallucinations and delusions.
Participants must not have received any type of psychological treatment in the past 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Have an education lower than a high school diploma
Be over fifty years of age or under eighteen years of age
Living outside the city of Hamedan</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>G43</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Migraine</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>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: A group that has been affected by short-term intensive dynamic psychotherapy. Intervention group: The group that has been affected by short-term intensive dynamic psychotherapy. Modified short-term psychodynamic psychotherapy is a therapeutic approach that is based on investigating and discovering the underlying causes of mental disorders and creating lasting changes in the patient's thought and behavioral patterns. This treatment method is usually carried out for a limited period of time (several months to a year) and the patient plays an active role in this process. In this study, a 15-session protocol based on the Duvanlu short-term intensive dynamic psychotherapy protocol will be used.</i_keyword>
      <i_keyword>Intervention group:  A group affected by acceptance and commitment therapy.Acceptance and Commitment Therapy is a branch of clinical behavior analysis. It is an empirically based psychological intervention that uses acceptance and mindfulness strategies along with commitment and behavior change strategies to increase psychological flexibility (Hayes et al., 2006). This study will use the 8-session Acceptance and Commitment Therapy protocol (Wells &amp; Sorrell, 2002).</i_keyword>
      <i_keyword>Intervention group: A group affected by schema therapy. Schema therapy was developed by Jeffrey Young for use in the treatment of personality disorders and chronic disorders. The goal of schema therapy is to help patients meet their basic emotional needs through the treatment of schemas, by reducing the intensity of emotional memories including the schema and the intensity of physical sensations, and by changing the cognitive patterns associated with the schema (Young, 2006; Klasko, Wishar, 2006). In this study, a 10-session protocol based on group schema therapy (Young et al., 2003) will be used.</i_keyword>
      <i_keyword>Control group: Group not affected by any treatment</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The Nolen-Hooksman Rumination Questionnaire score of patients with migraines is reduced. Timepoint: Before the intervention, after the intervention, and one month after the intervention. Method of measurement: Nolen-Hooksman Questionnaire.</prim_outcome>
      <prim_outcome>The score of Band et al.'s Experiential Avoidance Questionnaire related to experiential avoidance in patients with migraines should be reduced. Timepoint: Before the intervention, after the intervention, and one month after the intervention. Method of measurement: Band et al. Experiential Avoidance Questionnaire.</prim_outcome>
      <prim_outcome>The McGill Pain Questionnaire score in relation to pain intensity in patients with migraines should be reduced. Timepoint: Before the intervention, after the intervention, and one month after the intervention. Method of measurement: McGill pain questionnaire.</prim_outcome>
      <prim_outcome>The score of the International Standard Quality of Life Questionnaire SF36 increases in patients with migraine. Timepoint: Before the intervention, after the intervention, and one month after the intervention. Method of measurement: Quality of life questionnaire International Standard Quality of Life SF36.</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>The Lorestan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-10-14</approval_date>
        <contact_name>Ethics committee of Lorestan University of Medical Sciences</contact_name>
        <contact_address>No. 7, 12 Metri Sangshir Ave HAMEDAN Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
