<?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>IRCT2015052916564N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-09-10</date_registration>
      <primary_sponsor>Urmia University of Medical Sciences, Vice Chancellor of Research</primary_sponsor>
      <public_title>Effect of  a caring  model on the  readmission of depressed patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of  adaptive sustainability  as a caring  model on the readmission of depressed patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-06-10</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>100</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/15477</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: we use  sealed envelopes that containing the names  of intervention and control groups.</study_design>
      <phase>2</phase>
      <hc_freetext>Major depression disorder.</hc_freetext>
      <i_freetext>Intervention 1: The control group (50 person) will received only usual care. Intervention 2: At first, the knowledge and attitude of the patient and his family about the depression will be collected through an interview. In the second step, the desensitization process will be carried out. The purpose of this stage is to de-stigmatize and change family’s attitude toward depression. The sessions will continue to reform family’s attitude toward depression.&#13;
In the third phase, the family will be prepared for the care of patient after discharge. In order to achieve this aim, the researcher will provide the patient’s family with three sessions of consultation about depression, its symptoms, treatment methods, how to communicate with the patient and to care for the patient at home. The information will be provided according to the four stages of the crisis, acute, health care and health promotion. During all these stages the families would be able to access the researcher, and if needed ask him to help them. &#13;
In the fourth stage, which is the stage after the patient's discharge, the family is continually monitored. For this purpose, the researcher will communicate with the family by phone and face to face, once a week in first month after discharge. During these communications, adherence to treatment, regular visit to psychiatrist, probable problems will be monitored, and if required intervention will be done. From the second month the patient's family will be contacted once every two weeks.</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>NaserEsazadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 6, Alley Zamandost, 22 Bahman Ave., Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5715775693</zip>
        <telephone>+98 44 3346 3872</telephone>
        <email>esazadeh.n@umsu.ac.ir</email>
        <affiliation>Urmia University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Moloud Radfar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 10, sixth alley, Dorostkar Blvd, Urmia</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115111</zip>
        <telephone>+98 44327549614</telephone>
        <email>Radfar.m@umsu.ac.ir; mradfar1343@gmail.com</email>
        <affiliation>Faculty of Nursing &amp; Midwifery</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The most important of inclusion criteria:  not having hospitalization record more than one time; the definitive diagnosis of depression by psychiatrist; age 20 to 55 years old; living with family; not having physical health problems or disabilities; not having drug addiction except cigarettes. &#13;
The most important of exclusion criteria: Drug and alcohol addiction after enrolled to the study; Cognitive impairment.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>55 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Severe depressive episode with psychotic symptoms</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The control group (50 person) will received only usual care.</i_keyword>
      <i_keyword>At first, the knowledge and attitude of the patient and his family about the depression will be collected through an interview. In the second step, the desensitization process will be carried out. The purpose of this stage is to de-stigmatize and change family’s attitude toward depression. The sessions will continue to reform family’s attitude toward depression.&#13;
In the third phase, the family will be prepared for the care of patient after discharge. In order to achieve this aim, the researcher will provide the patient’s family with three sessions of consultation about depression, its symptoms, treatment methods, how to communicate with the patient and to care for the patient at home. The information will be provided according to the four stages of the crisis, acute, health care and health promotion. During all these stages the families would be able to access the researcher, and if needed ask him to help them. &#13;
In the fourth stage, which is the stage after the patient's discharge, the family is continually monitored. For this purpose, the researcher will communicate with the family by phone and face to face, once a week in first month after discharge. During these communications, adherence to treatment, regular visit to psychiatrist, probable problems will be monitored, and if required intervention will be done. From the second month the patient's family will be contacted once every two weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Readmission. Timepoint: Within 6 months and  6 months after the intervention. Method of measurement: Based on the frequency of hospitalization.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Urmia University of Medical Sciences, Vice Chancellor of Research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-05-07</approval_date>
        <contact_name>Ethics committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Next Emergency Center, Resalat Blvd, Urmia University of Medical Sciences and Health Service Urmia  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
