<?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>IRCT20180823040855N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-09-12</date_registration>
      <primary_sponsor>Ahvaz University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of  Self-Care-Based Cognitive Behavioral Therapy on Depression</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of  Self-Care-Based Cognitive Behavioral Therapy on Depression During Pregnancy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2018-07-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>68</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/33517</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The samples are randomly divided into two groups of intervention and control. The software is random statistical software.</study_design>
      <phase>N/A</phase>
      <hc_freetext>depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention according to a protocol called cognitive-behavioral self-care cognitive-behavioral therapy, a guide for women, written by Dr. Michel Herring Cognitive-behavioral counseling counselor in collaboration with the British Columbia mental health program, mental health services in British Columbia. The intervention was presented as 7 sessions of one-hour cognitive-behavioral group therapy once a week. The sessions include: providing information on depression, providing information on treatment options in women with depression during pregnancy and postpartum, including drug therapy and psychological treatments such as cognitive-behavioral therapy, explaining cognitive-behavioral therapy and its role in depression, Explain self-care and its importance, a description of different areas of self-care such as nutrition, exercise and the way to incorporate and nurture each of these areas in the person's life, how to determine the goal of developing each of the areas of self-care and learning to solve existing problems To make positive changes in life, educate all kinds of wrong thoughts Intensify depression, learn how to identify and challenge these ideas, and provide solutions to prevent the return of symptoms of depression. Intervention 2: Control group: The routine midwifery care group will receive a midwife from the health center and will be monitored for interventional factors.</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 total data of individuals after being unidentifiable is shared.

When:
Two months after the publication of the article

To whom:
Anyone interested can access the data.

Conditions:
In the case of citations for other research or comparison of results with other research

Where to obtain:
Masumeh Mehri
mehry.masumeh@ yahoo.com
009163223880

How to obtain:
A correspondent with the researcher's email and an explanation of the purpose of reading and using the data

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Masumeh Mehri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golestan, Esfand Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3336 1544</telephone>
        <email>itc@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mina Iravani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>School of Nursing and Midwifery, Jundishapur University of Medical Sciences, Ahvaz University City, Khouzestan, Ahvaz</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>15794-61357</zip>
        <telephone>+98 61 3373 8538</telephone>
        <email>iravani-m@ajums.ac.ir</email>
        <affiliation>Ahvaz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gravid First
Age of 15 to 45 years
Ability to speak Persian
Literacy reading and writing
Earn score 10 to 15 from the Edinburgh Postpartum Depression Inventory
Gestational age 22 to 26 weeks</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>45 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Drug abuse
Cause of other Mental Illnesses other than Major Depressive Disorder
Neurological Diseases
Receive any Treatment during Research for Major Depressive Disorder
BMI More than 25</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention according to a protocol called cognitive-behavioral self-care cognitive-behavioral therapy, a guide for women, written by Dr. Michel Herring Cognitive-behavioral counseling counselor in collaboration with the British Columbia mental health program, mental health services in British Columbia. The intervention was presented as 7 sessions of one-hour cognitive-behavioral group therapy once a week. The sessions include: providing information on depression, providing information on treatment options in women with depression during pregnancy and postpartum, including drug therapy and psychological treatments such as cognitive-behavioral therapy, explaining cognitive-behavioral therapy and its role in depression, Explain self-care and its importance, a description of different areas of self-care such as nutrition, exercise and the way to incorporate and nurture each of these areas in the person's life, how to determine the goal of developing each of the areas of self-care and learning to solve existing problems To make positive changes in life, educate all kinds of wrong thoughts Intensify depression, learn how to identify and challenge these ideas, and provide solutions to prevent the return of symptoms of depression.</i_keyword>
      <i_keyword>Control group: The routine midwifery care group will receive a midwife from the health center and will be monitored for interventional factors.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pregnancy Depression Score in Edinburgh Postpartum Depression Questionnaire. Timepoint: At the beginning of the study, immediately, 4 weeks and 8 weeks after the end of the intervention. Method of measurement: Edinburgh Postpartum Depression Questionnaire.</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>Ahvaz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2018-07-14</approval_date>
        <contact_name>The Ethics Committee of Ahvaz Jundishapur University of Medical Sciences</contact_name>
        <contact_address>Golestan, Esfand Street Ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
