<?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>IRCT20260509069302N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-05-19</date_registration>
      <primary_sponsor>Behboudi Green Villa Maintenance Center</primary_sponsor>
      <public_title>Cognitive Behavioral Therapy</public_title>
      <acronym>CBT</acronym>
      <scientific_title>The Effectiveness of Cognitive Behavioral Therapy (CBT) on Post‑Traumatic Stress, Mental Health, and Depression in Neglected and Orphaned Adolescents Living in Residential Care Centers in Shiraz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-05-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/90034</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Eligible participants will be enrolled after providing informed consent. Participants will then be randomly assigned to either the intervention group (cognitive behavioral therapy) or the control group using simple randomization based on a computer-generated random numbers table. The allocation ratio will be 1:1.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression, post-traumatic stress.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Participants in this group will receive group‑based Cognitive Behavioral Therapy (CBT). The intervention consists of eight weekly sessions lasting 60 minutes each, delivered by a trained therapist. The sessions include cognitive restructuring, identification and modification of dysfunctional thoughts, coping skills training, and emotion regulation techniques. Intervention 2: Control group: Participants in this group will receive routine services provided by the residential center and will not receive the CBT intervention during the study period. After completion of the study, the intervention will be offered if desired.</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:
Only part of the data, such as information related to the main outcome or the like, can be shared.

When:
Access period starts from March 2027

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

Conditions:
General data is for guidance only.

Where to obtain:
I am Seyyed Tara Hosseini Haghighi - Rost Psychological Counseling and Services Center - Shiraz, North Motahari Boulevard - Ibn Sina Medical Building - Second Floor, Unit 8 - 09173127361

How to obtain:
The applicant must send his/her application with a complete explanation of why and how the work is being done to my email address tarah.hosseini.h@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyede Tarah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fadak st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7156787498</zip>
        <telephone>+98 71 3725 8261</telephone>
        <email>tarah.hosseini.h@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyede Tarah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Fadak st.</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7156787498</zip>
        <telephone>+98 71 3725 8261</telephone>
        <email>tarah.hosseini.h@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having diagnostic criteria for depressive disorders
Age 12 to 18 years
Parental consent
Availability of the individual</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Presence of severe psychiatric disorders such as psychotic disorders or bipolar disorder based on medical records or clinical assessment
Cognitive or intellectual impairment that interferes with understanding or participation in cognitive behavioral therapy sessions
Concurrent participation in structured psychological therapy similar to the intervention at the time of enrollment
Changes in psychiatric medication within the past four weeks
Presence of severe or unstable medical illness that prevents participation in therapy sessions
Lack of informed consent from the legal guardian or the adolescent participant</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other depressive episodes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Participants in this group will receive group‑based Cognitive Behavioral Therapy (CBT). The intervention consists of eight weekly sessions lasting 60 minutes each, delivered by a trained therapist. The sessions include cognitive restructuring, identification and modification of dysfunctional thoughts, coping skills training, and emotion regulation techniques.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive routine services provided by the residential center and will not receive the CBT intervention during the study period. After completion of the study, the intervention will be offered if desired.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post‑traumatic stress disorder score measured by a PTSD scale at baseline and after completion of the intervention. Timepoint: Before treatment, after the end of treatment. Method of measurement: Mississippi Questionnaire.</prim_outcome>
      <prim_outcome>Score of mental health measured by the General Health Questionnaire (GHQ‑28) at baseline and after completion of the intervention. Timepoint: Before treatment, after the end of treatment. Method of measurement: General Health Questionnaire (GHQ-28).</prim_outcome>
      <prim_outcome>Severity of depressive Depression score measured by a depression questionnaire at baseline and after completion of the intervention. Timepoint: Before treatment, after the end of treatment. Method of measurement: Beck depression questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Post‑traumatic stress disorder score measured by a PTSD scale at baseline and after completion of the intervention. Timepoint: After the intervention. Method of measurement: Mississippi Questionnaire.</sec_outcome>
      <sec_outcome>Score of mental health measured by the General Health Questionnaire (GHQ‑28) at baseline and after completion of the intervention. Timepoint: After the intervention. Method of measurement: General Health Questionnaire (GHQ-28).</sec_outcome>
      <sec_outcome>Depression score measured by a depression questionnaire at baseline and after completion of the intervention. Timepoint: After the intervention. Method of measurement: Beck depression questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>Islamic Azad University</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Behboudi Green Villa Maintenance Center</source_name>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-05-30</approval_date>
        <contact_name>Ethics Committee of Firozabad Azad University</contact_name>
        <contact_address>No 34, Fadak Blvd shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
