<?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>IRCT20250616066202N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-07</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of trauma-focused cognitive behavioral therapy on domestic violence</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of trauma-focused cognitive behavioral therapy on feelings of guilt, emotional self-regulation, and attachment style of women victims of domestic violence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>92</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/84907</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Code Assignment: Each of the 30 participants will be assigned a unique identification code (from 1 to 30).
Random Sequence Generation: Using the website www.random.org (which is a reputable random number generator service), a random list of numbers from 1 to 30 will be generated.
Group Assignment: The first 15 numbers from this random list will be considered the “experimental” group and the next 15 numbers will be considered the “control” group.
Implementation: The names of the participants corresponding to the codes selected for each group will be identified and assigned to the corresponding group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Women victims of domestic violence exposed to trauma.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The therapeutic intervention will be implemented in the experimental group and then a post-test will be administered. The intervention will be implemented in the form of trauma-based cognitive behavioral therapy in eight sessions. One 90-minute session will be held each week and the course will last two months. The first session: Introduction and interview with the subjects. The second session: Psychological preparation regarding trauma and recognition of different types of emotions. Session Three: Emotional skills, including emotional adjustment skills, including identifying and rating emotions and emotional self-regulation training. Session Four: Relaxation skills training, progressive muscle relaxation and deep breathing, relaxation skills. Session Five: Trauma narration and post-traumatic experience processing, trauma sharing. Sixth session: Examining guilt and attachment styles, identifying attachment styles and emotional and behavioral barriers. Emotional barriers. Seventh session: Prevention and training in coping strategies. Eighth session: Conclusion, summary and explanation for preventing relapse. Intervention 2: No intervention is performed in the control group.</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 There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reza Davasaz Irani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health, Fatemi Street, Amanie</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۱۳۵۷۱۵۷۹۴</zip>
        <telephone>+98 61 3314 0000</telephone>
        <email>reza.davasazirani@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Davasaz irani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Health, Fatemi Street, Amanie</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6135715794</zip>
        <telephone>+98 61 3333 6919</telephone>
        <email>Reza.davasazirani@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Women victims of domestic violence in the Ahvaz city welfare center
Completing the informed consent form</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Dissatisfaction with participating in a research study</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F43.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Post-traumatic stress disorder (PTSD)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The therapeutic intervention will be implemented in the experimental group and then a post-test will be administered. The intervention will be implemented in the form of trauma-based cognitive behavioral therapy in eight sessions. One 90-minute session will be held each week and the course will last two months. The first session: Introduction and interview with the subjects. The second session: Psychological preparation regarding trauma and recognition of different types of emotions. Session Three: Emotional skills, including emotional adjustment skills, including identifying and rating emotions and emotional self-regulation training. Session Four: Relaxation skills training, progressive muscle relaxation and deep breathing, relaxation skills. Session Five: Trauma narration and post-traumatic experience processing, trauma sharing. Sixth session: Examining guilt and attachment styles, identifying attachment styles and emotional and behavioral barriers. Emotional barriers. Seventh session: Prevention and training in coping strategies. Eighth session: Conclusion, summary and explanation for preventing relapse.</i_keyword>
      <i_keyword>No intervention is performed in the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Feelings of guilt. Timepoint: Measurement of guilt at the beginning of the study (before the intervention, week one) and immediately after the end of the last intervention session (week eight). Method of measurement: Kugler and Jones Guilt Questionnaire.</prim_outcome>
      <prim_outcome>Emotional self-regulation. Timepoint: Measurement of emotional self-regulation at the beginning of the study (before the intervention, week one) and immediately after the end of the last intervention session (week eight). Method of measurement: Emotional Self-Regulation Questionnaire (Emotional Styles).</prim_outcome>
      <prim_outcome>Attachment style. Timepoint: Attachment style measurement at the beginning of the study (before the start of the intervention, the first week) and immediately after the end of the last intervention session (the eighth week). Method of measurement: Adult Attachment Style 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 Ahvaz University, Ahvaz Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-05-15</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University of Ahvaz Branch</contact_name>
        <contact_address>Islamic Azad University, Ahvaz Branch- Farhang Shahr-Golestan higway ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
