<?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>IRCT20251121068066N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-12-25</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Integrative Therapy on Individual-Social Adjustment, Resilience, and Cognitive Emotion Regulation in Teachers with Psychosomatic Symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Integrative Therapy on Individual-Social Adjustment, Resilience, and Cognitive Emotion Regulation in Teachers with Psychosomatic Symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-12-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/88158</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Participants were randomly assigned to one of two study groups: an experimental group (receiving the intervention) and a control group (receiving no intervention). A total of 36 participants were enrolled, with 18 participants allocated to each group, Blinding description: This study is conducted using a double-blind design. Both the participants and the individual responsible for sample selection and outcome assessment are unaware of the group assignments. Participants do not have any information regarding whether they are allocated to the experimental or control group. Group allocation is concealed during the study period, and blinding is maintained throughout data collection and assessment to minimize bias.</study_design>
      <phase>3</phase>
      <hc_freetext>Psychosomatic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants received nine weekly group sessions of integrative therapy based on Feldman’s approach, incorporating psychodynamic and cognitive components. Each session lasted 90 minutes. Intervention 2: Control group: Participants received no intervention during the study period and were offered the intervention after completion of the study.</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 No further information available.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8135866531</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Gholamreza Talebi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>2nd Floor, Padna Building, No. 44, Amin Alley, Sheyri Bridge, opposite Seyed-al-Shohada Hospital, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8514143131</zip>
        <telephone>+98 913 317 0681</telephone>
        <email>rezatalebi@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Exhibiting psychosomatic symptoms based on the interview
Being a young or middle-aged teacher.
No history of acute psychological disorders (e.g., depression, anxiety) based on psychiatric history.
Ability and willingness to provide informed consent and participate in the study.
No receipt of psychological treatment for the control group.
No psychological treatment other than the study for the experimental group.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Lack of cooperation with the researcher, including irregular attendance at sessions or failure to complete treatment protocol assignments.
Irregular attendance (more than three missed sessions).
Worsening of the condition due to the intervention leading to psychological harm, such as suicidal thoughts.
Occurrence of specific events, such as the development of another chronic physical illness during the study period.</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>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants received nine weekly group sessions of integrative therapy based on Feldman’s approach, incorporating psychodynamic and cognitive components. Each session lasted 90 minutes.</i_keyword>
      <i_keyword>Control group: Participants received no intervention during the study period and were offered the intervention after completion of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Social Adjustment: Measured using the California Social Adjustment Questionnaire. Timepoint: Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up. Method of measurement: The California Personal-Social Adjustment Questionnaire (CPI), measures life adjustment across two domains: personal and social adjustment. The questionnaire contains 180 yes/no items divided into 12 subscales. Items 1–90 assess personal adjustment, while items 91–180 assess social adjustment.</prim_outcome>
      <prim_outcome>Resilience: Measured using the Connor–Davidson Resilience Questionnaire. Timepoint: Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up. Method of measurement: Resilience is measured using the Connor–Davidson Resilience Questionnaire (CD-RISC), which consists of 25 items rated on a Likert scale from 0 (completely false) to 5 (always true). The questionnaire evaluates the participant’s ability to cope with stress and adapt to challenging situations, providing a total score that reflects overall resilience.</prim_outcome>
      <prim_outcome>Cognitive Emotion Regulation: Cognitive emotion regulation refers to the cognitive strategies used to manage emotionally arousing information. It is measured using the Garnefski and Kraaij Cognitive Emotion Regulation Questionnaire (CERQ). Timepoint: Measurements will be taken at three stages: pre-test (before intervention), post-test (immediately after intervention), and three-month follow-up. Method of measurement: Cognitive Emotion Regulation: Measured using the Cognitive Emotion Regulation Questionnaire (CERQ) developed by Garnefski and Kraaij (2006). The questionnaire contains 18 items assessing adaptive and maladaptive strategies across 9 components: self-blame, rumination, catastrophizing, blaming others, positive refocusing, refocusing on planning, acceptance, positive reappraisal, and perspective-taking. Items are rated on a 5-point Likert scale from 1 (never) to 5 (always).</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>2025-05-01</approval_date>
        <contact_name>Specialized Committee on Ethics in Biomedical Research</contact_name>
        <contact_address>Daneshgah Blvd, Najafabad, Isfahan Province Najafabad Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
