<?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>IRCT20171125037622N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-12-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effectiveness of Integrative psychotherapy on Patients with Scleroderma</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Integrative psychotherapy on Body Image, Self-esteem and Sexual Function in Patients with systemic sclerosis (Scleroderma)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-12-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/27812</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: The design of a unified protocol for educational and psychotherapy based on a four-factor common model for patients with scleroderma, Randomization description: At first, available patients are selected and then randomly assigned (using sealed envelopes) to the two groups of test and control, and the individual randomization unit, Blinding description: Single-blind study is just for the participants, and since psychological intervention is directly taught by the researcher also the evaluation and control operations are conducted by him, the researcher is aware of the method of study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>systemic sclerosis (Scleroderma).</hc_freetext>
      <i_freetext>Intervention group:.</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 data can be shared after unidentifiable people.

When:
Since 2018/04

To whom:
Researchers and practitioners in the field of mental and physical health

Conditions:
For scientific and research use of students, professors and researchers is permitted.

Where to obtain:
Referring to the library of Islamic Azad University, Karaj Branch; Sending a message to a private mail; l.shamkoeyan@gmail.com

How to obtain:
Send a message to your personal and e-mail and Answer during 5 days

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Layla Shamkoeyan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 19,. Hasan Sayf. 20., Hasan Sayf Ave., Farahzadi Blvd., Qods Town</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1466746581</zip>
        <telephone>+98 21 8807 0642</telephone>
        <email>l.shamkoeyan@kiau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farah Lotfi Kashani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>PO Box: 189, Roudehen, Tehran</address>
        <city>Roudehen</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۹۷۳۱۸۸۹۸۱</zip>
        <telephone>+98 21 8830 5686</telephone>
        <email>lotfikashani@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>All patients whose information is recorded in the Department of Rheumatology of the Shariati Hospital (based on the American College of Rheumatology package  or formerly the American Rheumatism Association).
At least one year has passed from diagnosing scleroderma.
Residents in Tehran and its surroundings
Complete the aware and voluntary consent form for participation in the research</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients should not be afflicted with mental disorders (in accordance with DSM V).
Do not have a history of taking psychoactive drugs over the past 3 months.
Patients who have had three absences due to the nature of the illness during the intervention sessions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>M34</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Systemic sclerosis [scleroderma]</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: </i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body image worry score in Littleton's body image worry questionnaire. Timepoint: To measure the effectiveness of unified therapy psychotherapy on the amount of body image anxiety, we measure the amount of body image anxiety before the intervention (pre test), after the intervention (post test) and one month after the last day of the intervention (follow up). Method of measurement: To investigate the effect of integrated psychotherapy on body image anxiety, we use the Littleton's Physical Image Worry Questionnaire.</prim_outcome>
      <prim_outcome>Self-esteem score in Cooper Smith self-esteem questionnaire. Timepoint: To evaluate the efficacy of integrated therapy for self-esteem,  We measure the amount of self-esteem before the intervention (pre-test), after the intervention (post-test) and one month after the last day of the intervention (follow up). Method of measurement: To investigate the effect of integrated psychotherapy on self-esteem, we use the Cooper Smith self-esteem questionnaire.</prim_outcome>
      <prim_outcome>Sexual Function Score in female Sexual Function Index (FSFI). Timepoint: To evaluate the efficacy of integrated therapy for sexual performance, We measure the amount of sexual function before the intervention (pre -test) , after the intervention (post-test) and one month after the last day of the intervention (follow up). Method of measurement: Function Index Female Sexual and International Index of Erectile Function.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-10-31</approval_date>
        <contact_name>Ethics committee of islamic azad univercity, karaj branch</contact_name>
        <contact_address>Rajai Shahr، Moazzen Boulevard Karaj Alborz Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
