<?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>IRCT2017071826484N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-09-11</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran University of Medical Science</primary_sponsor>
      <public_title>Comparison of the Effectiveness of Cognitive Behavioral Therapy Based on Virtual Content with Drug Therapy in Postpartum Depression in Improving Weight Indices in Children Up to 4 Months</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Cognitive Behavioral Therapy Based on Virtual Content with Drug Therapy in Postpartum Depression in Improving Weight Indices in Children Up to 4 Months</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>110</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/21943</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The sample size is randomly divided into two groups, of which two groups will be in terms of maternal age. In one group, a previous routine therapy will be implemented, and in the second group, cognitive-behavioral therapy will be implemented based on virtual content, in which behavioral-cognitive behavioral techniques including depression, anxiety and depression control, coping strategies, the role of negative thoughts And emotional relationship with it, problem-solving skills, peer-tracking and depressive mood development, lexical education, and effective communication styles training will be provided and these content will be taught to be virtual. In two groups, three sessions will be held in person, one meeting will be held at the beginning of the project,The second session on the second month of treatment (to find exacerbated cases or suicidal thoughts) and one session at the age of 4 months. During this period, counseling is also available 5 days a week from Saturday to Wednesday from 8 am to 4 pm Patients will be able to call in case of a problem. At 2 and 4 months of age, the Edinburgh questionnaire for mothers will be completed to compare mothers' depression in two groups. On the other hand, the weight of newborns at 2 months and 4 months of age will be measured in two groups by health care and calibrated. Also, the birth weight of newborns will be recorded on the apple system.In order to compare the mean of weight variations in two groups, ANCOVA analysis will be used.If the need for the sexually transmitted infant, the type of breastfeeding, birth rotation, and BMI of mothers will be considered in the covariance analysis model, for comparison. The efficacy of treatments for the improvement of postpartum depression, taking into account the outcome of the study as a variable, two (improved and unrecognized) and comparing two therapies, taking into account the confounding variables, of multiple logistic regression will be used.</study_design>
      <phase>N/A</phase>
      <hc_freetext>depression.</hc_freetext>
      <i_freetext>Intervention 1: In one group, a routine treatment, or drug treatment, will be performed, and the drug will be used according to the conditions&#13;
The patient will have 20-40 fluoxetine. &#13;
And the duration of the treatment is 4 months. Intervention 2: Cognitive Behavioral Therapy Based on Virtual Content, which will be provided to the patients by telegrams and patients will send us feedback on the exercises of this content.</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>Azam Ahadpour Khaneghah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zhiyin Hospital, Midan Fallah, Around the municipality of district 17, Abuzar,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5517 6818</telephone>
        <email>ahadpouraz@yahoo.com</email>
        <affiliation>Tehran University of Medical Science</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mrs. Ghazal Shariat Panahi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Zhiyin Hospital, Midan Fallah, Around the municipality of district 17, Abuzar,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 5517 6818</telephone>
        <email>gshariatpanahi@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences.</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The target community will be the mothers who gave birth to their children last week and have a score of over 13 in Edinburgh's depression; they also have to be literate and able to work with the telegram; other criteria of research The sentence is monogamous; lack of pregnancy problems; being treated without depression; having no thoughts of harm to yourself and others to enter the research.&#13;
&#13;
Exit criteria: double-ended; problems with pregnancy or illness; previous treatment due to depression; having thoughts of harm to yourself or others</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>وf32.1F32.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>mild and moderate depression</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In one group, a routine treatment, or drug treatment, will be performed, and the drug will be used according to the conditions&#13;
The patient will have 20-40 fluoxetine. &#13;
And the duration of the treatment is 4 months</i_keyword>
      <i_keyword>Cognitive Behavioral Therapy Based on Virtual Content, which will be provided to the patients by telegrams and patients will send us feedback on the exercises of this content.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Weight gaining. Timepoint: 0, 2 and 4 months after childbirth. Method of measurement: scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression improving. Timepoint: 0, 2 and 4 months of age. Method of measurement: Edinburg questionnaire.</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 Tehran University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-07-31</approval_date>
        <contact_name>Ethics Committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Zhiyin Hospital, Midan Fallah, Around the municipality of district 17, Abuzar, tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
