<?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>IRCT20180520039736N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-06-13</date_registration>
      <primary_sponsor>Isfahan Azad University, Isfahan (Khorasgan) Branch</primary_sponsor>
      <public_title>Development of Lifestyle educational Package and survey its Effectiveness in Patients with Ulcerative Colitis</public_title>
      <acronym></acronym>
      <scientific_title>Development of Lifestyle educational Package and Comparing its Effectiveness with Mindfulness-Based Cognitive Therapy on Disease Activity and Related Psychological Variables in Patients with Ulcerative Colitis</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-05-24</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/31323</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: survey of the validity of developed Lifestyle educational Package through a nested design(qualitative approach), Randomization description: randomized simple, Blinding description: Participants, Data analyzer.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Ulcerative Colitic.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The education of discovered Lifestyle educational Package. Intervention 2: Intervention group:  The education of Mindfulness-Based Cognitive Therapy. Intervention 3: Control group: Individual counseling in a session.</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:
The results of the research

When:
6 months after printing results

To whom:
For researchers who work in academic and scientific institutions

Conditions:
To report the results in other research studies by maintaining its source

Where to obtain:
mina.mazaheri@gmail.com

How to obtain:
Request by email

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mina Mazaheri Tehrani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.6, deadlock 2, Abdulrazagh St., Takhti Crossroad, Isfahan</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8173948763</zip>
        <telephone>+98 34462271</telephone>
        <email>mina.mazaheri@gmail.com</email>
        <affiliation>Esfahan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Asghar Aghaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daneshgah Bolvar, Arghavaniye, Sharghi Jey Ave, Isfahan Azad University, Isfahan (Khorasgan) Branch</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>81595158</zip>
        <telephone>+98 31 3535 4001</telephone>
        <email>aghaeipsy@gmail.com</email>
        <affiliation>Islamic Azad University, Isfahan (Khorasgan) Branch,</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Ulcerative Colitis
Conscious Consent to Participate in Research
Physical and mental ability to participate in interview or intervention
The level of education at least the end of the elementary school period
The age range of between 18-70 years old
Call number to invite to participating in intervention
Resident of the city</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>70 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>The acute phase of psychiatric disorders (such as bipolar disorder, severe depression)
Participating in counseling or psychotherapy sessions during the last 6 months
Lack of motivation to participate in the interview and the ability to express thoughts and feelings
Unwillingness to continue to participating in intervention</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K51</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Ulcerative colitis</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Lifestyle</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The education of discovered Lifestyle educational Package</i_keyword>
      <i_keyword>Intervention group:  The education of Mindfulness-Based Cognitive Therapy</i_keyword>
      <i_keyword>Control group: Individual counseling in a session</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Disease activity. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Lichtiger Colitis Activity Index.</prim_outcome>
      <prim_outcome>Fatigue Severity. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Fatigue Severity Scale.</prim_outcome>
      <prim_outcome>Self-Care Agency. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Exercise of Self-Care Agency Scale.</prim_outcome>
      <prim_outcome>Anxiety. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Hospital Anxiety Depresion Scale.</prim_outcome>
      <prim_outcome>Depresion. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Hospital Anxiety Depresion Scale.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Crohn’s and Ulcerative Colitis Questionnaire.</prim_outcome>
      <prim_outcome>Perceived stress. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Perceived stress scale.</prim_outcome>
      <prim_outcome>Illness Perception. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: Brief-Illness Perception Questionnaire.</prim_outcome>
      <prim_outcome>Disease related Concerns. Timepoint: Before the intervention, after the intervention, three months after the end of the intervention. Method of measurement: The Rating Form of Inflammatory Bowel Disease Patient Concerns.</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>Isfahan Azad University, Isfahan (Khorasgan) Branch</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-04-16</approval_date>
        <contact_name>Ethics committee of Isfahan Azad University, Isfahan (Khorasgan) Branch</contact_name>
        <contact_address>Daneshgah Bolvar, Arghavaniye, Sharghi Jey Ave, Isfahan Azad University (Khorasgan), Isfahan Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
