<?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>IRCT20201009048974N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-07</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effectiveness of trauma-focused cognitive-behavioral therapy in adolescents with complex post-traumatic stress disorder.</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of trauma-focused cognitive-behavioral therapy(TF-CBT) on adolescents' psychological and cognitive structures with complex post-traumatic stress disorder(CPTSD).</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>32</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/63030</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be a simple Randomization method. The random unit is individuals.32 Adolescents with complex post-traumatic stress disorder will be divided into intervention and control groups by the software Exel software using Rand. in this way, a table of random numbers is prepared, and the Randbetween function is created. The adolescents are divided into two groups of 16 people, respectively, Blinding description: The outcome assessor in data collection after the intervention and the analysts will be unaware of the study's objectives.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Complex post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: For the experimental group, trauma-focused cognitive therapy is conducted according to the protocol of Cohen et al. Their treatment routine is 12 sessions of 45 minutes, once a week as an individual, which will be performed by a psychologist who is a doctoral student in clinical psychology under the supervision of a tutor. This method has been developed as a step-by-step approach that includes the following components: 1- psychoeducation and parenting skills, 2- Relaxation skills, 3- Emotional adjustment and expression, 4- Cognitive processing and coping and trauma narration, 6- Trauma reminders in Body, 7- Joint parent-child therapy sessions, 8- Strengthening security and 9- Future growth. Intervention 2: Control group: Initially, the control group did not receive any intervention, and only the results of their assessments performed by the questionnaire will be compared with the intervention group. At the end of the study, the trauma-focused cognitive-behavioral intervention will be completed in 12 individual 45-minute sessions according to the Cohen protocol.</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 There is no more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maryam Bakhtiari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>dr.m.bakhtiari@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Homa Shahkaram</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 3203 1548</telephone>
        <email>Homa.shahkaram@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Minimum age 12 and maximum 18 years.
To obtain the desired score in the International Trauma Questionnaire (to diagnose CPTSD, in addition to getting the required score in PTSD clusters, the person must have a score equal to or higher than 10 in the DSO cluster for items AD5-AD1 or a score similar to AD6-AD9 or Above 10, score NSC equal to or higher than eight and score DR points equal to or higher than 6).
Not having adolescents with mental disorders requiring immediate treatment such as substance abuse and psychotic disorders based on clinical interview.
Lack of intense thinking about self-harm or suicide.
Not participating in psychological interventions during the last year (not participating in at least five psychotherapy sessions).
Willingness to participate in research.
Do not use psychiatric drugs.</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Two consecutive absences in the process of meetings.
Thinking about suicide during the research
Adolescents suffer from mental disorders requiring immediate treatment, such as substance and alcohol use disorders and psychotic disorders during the study
Simultaneous participation in another psychotherapy program.</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: For the experimental group, trauma-focused cognitive therapy is conducted according to the protocol of Cohen et al. Their treatment routine is 12 sessions of 45 minutes, once a week as an individual, which will be performed by a psychologist who is a doctoral student in clinical psychology under the supervision of a tutor. This method has been developed as a step-by-step approach that includes the following components: 1- psychoeducation and parenting skills, 2- Relaxation skills, 3- Emotional adjustment and expression, 4- Cognitive processing and coping and trauma narration, 6- Trauma reminders in Body, 7- Joint parent-child therapy sessions, 8- Strengthening security and 9- Future growth.</i_keyword>
      <i_keyword>Control group: Initially, the control group did not receive any intervention, and only the results of their assessments performed by the questionnaire will be compared with the intervention group. At the end of the study, the trauma-focused cognitive-behavioral intervention will be completed in 12 individual 45-minute sessions according to the Cohen protocol.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self-harm. Timepoint: Beginning of the study (before the intervention) -6 months after the intervention. Method of measurement: Sanson et al. Self -harm Questionnaire (SHI).</prim_outcome>
      <prim_outcome>Difficulty regulating excitement. Timepoint: Beginning of the study (before the intervention) -6 months after the intervention. Method of measurement: Gretz and Roemer Emotion Difficulty Questionnaire (DERS).</prim_outcome>
      <prim_outcome>Bode Image. Timepoint: Beginning of the study (before the intervention) -6 months after the intervention. Method of measurement: Littleton.Body Image Fear Questionnaire (BICI).</prim_outcome>
      <prim_outcome>Trauma-related memory quality. Timepoint: Beginning of the study (before the intervention) -6 months after the intervention. Method of measurement: Meiser-Stedman. Trauma Memory Quality Questionnaire (TMQQ).</prim_outcome>
      <prim_outcome>Dissociative experiences. Timepoint: Beginning of the study (before the intervention) -6 months after the intervention. Method of measurement: Bernstein and Carlson. Dissociative Experiences Scale (DES-II).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-03-08</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Iran - Tehran - Shahid Chamran Highway Yemen Street - Shahid Arabi Street - next to Ayatollah Taleghani Hospital - Shahid Beheshti School of Medical Sciences Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
