<?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>IRCT2017092532057N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-10-31</date_registration>
      <primary_sponsor>Vice chancellor for research of Kashan University of Medical Sciences and Health Services</primary_sponsor>
      <public_title>Effectiveness Of Acceptance and Commitment Therapy on psychosomatic disorders</public_title>
      <acronym></acronym>
      <scientific_title>A Randomized clinical trial to evaluate the effectiveness of Acceptance and Commitment Therapy on Body image, Body Awareness, mindfulness, psychiatric symptoms and psychosomatic symptoms among patients suffering from Psychosomatic disorders</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>75</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/25071</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The study population include all somatic patients admitted to Shahid Beheshti Hospital. Of all participants who meet inclusion criteria, 25 participants in each group will be selected by Random allocation using random computer-generated numbers. Pre-test will be done by the person responsible for study. Intervention duration is ten weeks. Post-test data will be collected one week after intervention and eight weeks later through follow-up.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychosomatic disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on Body image, Body Awareness, mindfulness, psychiatric and psychosomatic symptoms of Kashan Psychosomatic patients. The aim of this approach is inviting people to open up unpleasant feelings and learn not to overreact them, and not avoiding situations where they are invoked. Its therapeutic effect is a positive spiral where feeling better leads to a better understanding of the truth and also experiencing flexible life. This treatment will be delivered through ten 90-minute sessions for ten weeks. Intervention 2: Control Group: Based on physician prescription this group will receive usual medical treatment. Intervention 3: Control Group: This group will receive behavioral interventions based on the psychoeducation during ten 90-minute per sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdollah Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th kilometer of Qotbe Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>abomidi20@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences and Health Services</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Abdollha Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th kilometer of Qotbe Ravandi Blvd</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 31 5554 9111</telephone>
        <email>abomidi20@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences and Health Services</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: being at the age of 18–50 years; Having high school certificate (Diploma) or higher education degree; Having one of the psychosomatic Disorders based on DSM 5 diagnostic criteria; not having a history of psychotic disorders; not having history of  psychotherapy during past six months; not having a history of substance abuse disorders.&#13;
Exclusion criteria: Unwillingness to continue participating in the study; Failing to participate in more than two sessions of the study intervention.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Somatoform disorders</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study is conducted to determine the effectiveness of Acceptance and Commitment Therapy (ACT) on Body image, Body Awareness, mindfulness, psychiatric and psychosomatic symptoms of Kashan Psychosomatic patients. The aim of this approach is inviting people to open up unpleasant feelings and learn not to overreact them, and not avoiding situations where they are invoked. Its therapeutic effect is a positive spiral where feeling better leads to a better understanding of the truth and also experiencing flexible life. This treatment will be delivered through ten 90-minute sessions for ten weeks</i_keyword>
      <i_keyword>Control Group: Based on physician prescription this group will receive usual medical treatment.</i_keyword>
      <i_keyword>Control Group: This group will receive behavioral interventions based on the psychoeducation during ten 90-minute per sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body image. Timepoint: Before intervention, One week after intervention, eight weeks after intervention. Method of measurement: Body Image – Acceptance &amp; Action Questionnaire.</prim_outcome>
      <prim_outcome>Body Awareness. Timepoint: Before intervention, One week after intervention, eight weeks after intervention. Method of measurement: body awareness questionnaire shields.</prim_outcome>
      <prim_outcome>Mindfulness. Timepoint: Before intervention, One week after intervention, eight weeks after intervention. Method of measurement: freiburg mindfulness scale.</prim_outcome>
      <prim_outcome>Psychosomatic symptoms. Timepoint: Before intervention, One week after intervention, eight weeks after intervention. Method of measurement: Diagnostic Criteria for Psychosomatic Research.</prim_outcome>
      <prim_outcome>Psychiatric sympoms. Timepoint: Before intervention, One week after intervention, eight weeks after intervention. Method of measurement: include Brief Symptom Inventory (BSI).</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>Vice chancellor for research of Kashan University of Medical Sciences and Health Services</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-08-23</approval_date>
        <contact_name>Ethics committee of kashan University of Medical Sciences</contact_name>
        <contact_address>Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th kilometer of Qotbe Ravandi Blvd Kashan  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
