<?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>IRCT20231030059904N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-01-04</date_registration>
      <primary_sponsor>Islamia university Bahawalpur</primary_sponsor>
      <public_title>Effect of Psychological Distress on Quality of Life, Self-Efficacy and Emotional Intelligence of School Teachers by Using Cognitive Behavioral Therapy</public_title>
      <acronym>CBT</acronym>
      <scientific_title>Managing Psychological Distress to Improve the Quality of Life, Self-Efficacy and Emotional Intelligence of School Teachers by Using Cognitive Behavioral Therapy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-02-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>176</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/75518</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Simple random sampling by including the government and private female school teachers from urban and rural areas of Layyah district equally. There are three tehsils in this district and data will be collected from each of them by using this sampling technique.</study_design>
      <phase>2</phase>
      <hc_freetext>Psychological distress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group: This group will receive Culturally Adopted Cognitive Behavioral Therapy to decrease their psychological distress and to improve quality of life, self-efficacy and emotional intelligence of school teachers. Culturally adopted cognitive behavior therapy is a dialogue written exercises based therapy that is comprised on eight sessions . All subjects of experimental group will receive one session in a week that will be comprised of 120 minutes. After completing eight sessions of psycho therapy, post assessment will be conducted to assess the effectiveness. Intervention 2: Control group: This group will be kept passive and will not receive any treatment during experiment.  Follow up will be taken of both groups after two months of post assessment.</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 It is not decided yet. The committee will held a meeting and will decide weather to share it or not..if yes then how much part of it must be shared.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Bisma Akhlaq</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Layyah</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>0606</zip>
        <telephone>420130</telephone>
        <email>bismakhlaq@gmail.com</email>
        <affiliation>Islamia University Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Aqeel Ahmed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Bahawalpur</address>
        <city>Bahawalpur</city>
        <country1>Pakistan</country1>
        <zip>63100</zip>
        <telephone>420130</telephone>
        <email>aqeel.ahmad@iub.edu.pk</email>
        <affiliation>Islamia University Bahawalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Female school teachers from government and private sector having at least one year experience
Female school teachers with same traits as age, marital status, experience
Female who  will score more on psychological distress scale
Agree to participate in Cognitive behavioral therapy intervention</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Male schools teachers
Female teachers with less than one year of experience
Those who score low on psychological distress scale</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention Group: This group will receive Culturally Adopted Cognitive Behavioral Therapy to decrease their psychological distress and to improve quality of life, self-efficacy and emotional intelligence of school teachers. Culturally adopted cognitive behavior therapy is a dialogue written exercises based therapy that is comprised on eight sessions . All subjects of experimental group will receive one session in a week that will be comprised of 120 minutes. After completing eight sessions of psycho therapy, post assessment will be conducted to assess the effectiveness.</i_keyword>
      <i_keyword>Control group: This group will be kept passive and will not receive any treatment during experiment.  Follow up will be taken of both groups after two months of post assessment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Level of psychological distress. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: The Kessler Psychological Distress Scale (K10) will be used to measure psychological distress. Quality of life by using the WHOQOL-BREF instrument. Self-efficacy will be measured by usingTeacher Self-Efficacy Scale (TSES), developed by Schwarzer et al. (1999) and emotional intelligence will be measured by using Brief Emotional Intelligence Scale (BEIS-10).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>To assess the impact of psychological distress on quality of life, self-efficacy and emotional intelligence of school teachers. Timepoint: Before the intervention, immediately after the intervention and 6 weeks after the intervention. Method of measurement: Psychological disrtess scale.</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>Islamia university Bahawalpur</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-07</approval_date>
        <contact_name>Institutional Human Ethics Committee (IHEC)</contact_name>
        <contact_address>Islamia University Bahawalpur Bhawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
