<?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>IRCT20250806066778N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-09-16</date_registration>
      <primary_sponsor>University of Tabriz</primary_sponsor>
      <public_title>Evaluating the Effectiveness of Prolonged Exposure Therapy for Post-Traumatic Stress Disorder (PTSD) in Reducing Symptoms and Improving Quality of Life among Veterans of the Iran–Iraq War</public_title>
      <acronym>PET</acronym>
      <scientific_title>"The effectiveness of Prolonged Exposure Therapy for Post-Traumatic Stress Disorder (PTSD) in reducing symptoms and improving the quality of life of veterans and combatants of the Eight-Year Iran-Iraq War."</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-09-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>15</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/85459</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Post-Traumatic Stress Disorder – PTSD.</hc_freetext>
      <i_freetext>In this study, the World Health Organization's 26-item short form of the Quality of Life Questionnaire (WHO-QOL-BREF) was used. The 17-item version of the Posttraumatic Stress Disorder Scale (interview form) developed by Foa, Riggs, Danko, and Rothiam (1993) will be used.An information session, and obtaining written consent and answers to possible questions from participants, 12 treatment sessions, which are weekly or twice a week, with each session usually lasting 90 minutes.No medication will be used in the treatment. The psychotherapy process is based on 4 important components of long-term exposure, namely psychoeducation, visual exposure, real exposure, and emotional processing, based on the treatment protocol presented by Foa et al..</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:
Stress is one of the factors threatening mental health and was one of the consequences of the eight-year Sacred Defense war in Iran. As research has shown, even more than forty years after the end of the war, many veterans or combatants (disabled war veterans) still suffer from post-traumatic stress disorder (PTSD). The most common symptoms among them are increased arousal and reactivity. Therefore, paying attention to this issue is still necessary and there is more work to be done.

When:
The preliminary studies for this project started in 2023 and, God willing, will be available by mid-2026.

To whom:
Respected university professors and those who want to provide services to the warriors and veterans of the eight years of sacred defense

Conditions:
If the intended goals are to help improve the quality of life of veterans and fighters of the eight years of sacred defense.

Where to obtain:
Website of the Vice Chancellor for Research and Research Technology of Ardabil University of Medical Sciences

How to obtain:
By visiting the website of the Vice President for Research and Research Technology of Ardabil University of Medical Sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Street, Daneshgah Square, Ardabil University of Medical Sciences Headquarters</address>
        <city>Ardabil</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8599156189</zip>
        <telephone>+98 45 3353 4722</telephone>
        <email>amiri100370@gmail.com</email>
        <affiliation>Ardabil University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Professor Abbas Bakhshipour</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Tabriz, 29 Bahman Boulevard, University of Tabriz</address>
        <city>Tabriz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5166616471</zip>
        <telephone>+98 41 3334 0081</telephone>
        <email>bakhshipour@gmail.com</email>
        <affiliation>University of Tabriz</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Active-duty or retired military personnel with a history of war-related trauma.
Having war-related Post-Traumatic Stress Disorder (PTSD) with a medical record and currently under pharmacological treatment.
No history of receiving psychological treatments prior to entering the study.
Ability to read and write.
Patient’s consent to participate in the study and signing the written informed consent form.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Suffering from other major psychiatric disorders (excluding PTSD and comorbid symptoms of depression and anxiety), such as personality disorders, psychotic disorders, or substance and alcohol addiction.
Having suicidal thoughts.
Possessing non-therapeutic motivations (e.g., seeking secondary gains such as increasing disability benefits).
Presence of severe medical conditions or physical injuries, such as spinal cord lesions, that would cause significant difficulties for the patient’s attendance in therapy sessions.</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>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, the World Health Organization's 26-item short form of the Quality of Life Questionnaire (WHO-QOL-BREF) was used. The 17-item version of the Posttraumatic Stress Disorder Scale (interview form) developed by Foa, Riggs, Danko, and Rothiam (1993) will be used.An information session, and obtaining written consent and answers to possible questions from participants, 12 treatment sessions, which are weekly or twice a week, with each session usually lasting 90 minutes.No medication will be used in the treatment. The psychotherapy process is based on 4 important components of long-term exposure, namely psychoeducation, visual exposure, real exposure, and emotional processing, based on the treatment protocol presented by Foa et al.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Percentage improvement (Scruggs and Mastropiri, 1998) in single-subject research designs is one of the quantitative indicators for measuring the effectiveness of interventions, which shows the amount of change in behavior or the dependent variable as a percentage compared to the baseline situation. Timepoint: Effect size in single-subject research designs is a quantitative indicator used to measure the extent to which an intervention has an effect on the dependent treatment (the behavior or outcome under study) and is strength or change. Method of measurement: In the present study, the 17-item version of the Posttraumatic Stress Symptoms Scale (interview form) developed by Foa, Riggs, Danko, and Rothiam (1993) will be used.</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>I have no financial resources</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-07-22</approval_date>
        <contact_name>Working Group of the Research Ethics Committee of the University of Tabriz</contact_name>
        <contact_address>Tabriz, Oruj Square, University of Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
