<?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>IRCT20200216046517N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-07-27</date_registration>
      <primary_sponsor>The University of Kurdistan</primary_sponsor>
      <public_title>Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms</public_title>
      <acronym>PTSD</acronym>
      <scientific_title>Effectiveness of Trauma-Focused Cognitive-Behavioral Therapy on PTSD Symptoms in Women Victims of Iraq War</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/49349</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization:
In this study, to randomly assign participants to two groups of 30, the Random function in MATLAB software was used to generate random numbers between 0 and 1; If the random numbers generated were less than 0.5, the person was placed in the experimental group and if it is more than 0.5, the person was placed in the control group.
It should be noted that after the completion of the study, an intervention was made for the control group to observe research ethics, Blinding description: One-way blinding:
 In this study, only participants (subjects) in both experimental and control groups are kept blind and have no information that there are two groups of control and experimental and do not have the type and form of intervention; Also, at each stage of pre-test, post-test and intervention (for the experimental group), they will not be given any additional information about the research. For example, those in the experimental group who have been intervened do not know that they have been intervened and that the class or workshop they are in is the same as the intervention; The control group, like the experimental group, does not know that there is an intervention and completing the questionnaire in the pre-test and post-test is just to collect some information.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-traumatic stress disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Shengali women victims of the Iraq war.                   The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Then TF-CBT intervention (including 12 sessions of 90 minutes per week) is performed on one group (experimental group) and therapeutic intervention is not performed on the control group. At the end of the intervention sessions, the research tools in the post-test phase are immediately implemented again for the members of both groups and their scores are compared with their previous scores according to the dependent variables of the research. Intervention 2: Control group: Shengali women victims of the Iraq war.                           The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Since no intervention is performed on the control group, after the intervention on the experimental group, post-test is performed on both groups simultaneously. Research tools in the post-test stage are immediately implemented for members of both groups and their scores are compared with their previous scores in terms of research-dependent variables.</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:
All research data

When:
Simultaneously with the release

To whom:
All researchers and enthusiasts

Conditions:
Only with the permission of researchers

Where to obtain:
The person responsible for the general response of the trial
The person responsible for the scientific accountability of the study
The person responsible for updating the information

How to obtain:
Send request via email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>The University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Zemestani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan, Iran</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>098 87 33664600-8</telephone>
        <email>m.zemestan@gmail.com</email>
        <affiliation>The University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iraq</country2>
    </countries>
    <criteria>
      <inclusion_criteria>War Trauma
Not receiving psychotherapy for the past six months
Depression
Diagnosis of PTSD based on DSM-5 criteria
Having at least a high school education
Age range between 18 and 50 years</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Pathological association with other psychiatric disorders
Psychotic symptoms
intellectual disability
Personality disorders</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: Shengali women victims of the Iraq war.                   The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Then TF-CBT intervention (including 12 sessions of 90 minutes per week) is performed on one group (experimental group) and therapeutic intervention is not performed on the control group. At the end of the intervention sessions, the research tools in the post-test phase are immediately implemented again for the members of both groups and their scores are compared with their previous scores according to the dependent variables of the research.</i_keyword>
      <i_keyword>Control group: Shengali women victims of the Iraq war.                           The method of conducting the research will be that initially the pre-test will be performed by research assistants on all members of both groups; Since no intervention is performed on the control group, after the intervention on the experimental group, post-test is performed on both groups simultaneously. Research tools in the post-test stage are immediately implemented for members of both groups and their scores are compared with their previous scores in terms of research-dependent variables.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Post-traumatic stress disorder. Timepoint: Before the intervention - after the intervention - one month after the intervention (follow-up). Method of measurement: Structured Clinical Interview for DSM-5 (SCID-5) - PTSD Checklist-5 - War-Related Trauma - Life Events Checklist - The Patient Health Questionnaire - Difficulties in Emotion Regulation Scale (DERS) - WHOQOL-BREF - The Depression, Anxiety, and Stress Scales with 21 items.</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>The University of Kurdistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-06-06</approval_date>
        <contact_name>Ethics Committee of University of Kurdistan (UOK)</contact_name>
        <contact_address>University of Kurdistan, Pasdaran St, Sanandaj, Kurdistan Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
