<?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>IRCT20210706051804N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-16</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Effect of Interpersonal Psychotherapy in Depressed Women</public_title>
      <acronym></acronym>
      <scientific_title>The Effectiveness of Interpersonal Psychotherapy on Reducing Depression Signs and Increasing Quality of Life in Depressed Women</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-16</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57475</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: Ordering individuals in to control and intervention group using Randomisation (individual type), with random number table.</study_design>
      <phase>N/A</phase>
      <hc_freetext>MDD.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: The reference of this protocol is: Comprehensive guide to interpersonal psychotherapy(Weissman, Markowitz&amp; Klerman, 2008), The guide to interpersonal psychotherapy(Weissman, Markowitz &amp; Klerman,2018),Interpersonal psychotherapy 2E a clinician's guide(Stuart &amp; Robertson,2012),Clinical handbook of psychological disorders: A step-by-step treatment manual(Barlow2014). Acute IPT treatment for major depression comprises initial, middle, and termination phases. And each session last50 to 60min(Barlow,2014): The Initial Phase (Sessions 1–3)Tasks of the initial sessions of IPT for major depression include eliciting the patient’s chief complaint; reviewing her symptoms and establishing a diagnosis; determining the interpersonal context for the current depressive episode; forming a therapeutic alliance; and setting the frame of the treatment, The Middle Phase (Sessions 4–9)Having made the treatment contract and chosen an interpersonal problem area as the focus of treatment, the therapist can proceed to the middle phase of sessions, in which the goal is to work on resolving the focal problem area. Each session begins with the question, “How have you been feeling since we last met?” This question elicits an interval history of mood, events, and interpersonal interactions that transpired between sessions. It also keeps the patient focused on current mood and situation. The patient is likely to respond by describing mood (“I felt really down”) or an event (“My husband and I had a huge fight”). After further inquiry, the therapist links the patient’s mood to a recent event, Oran event to her mood (“No wonder you felt depressed after the fight you had with your husband!”). The Termination Phase (Sessions 10–12)In the final sessions, the therapist reviews the patient's progress in symptom improvement, as well as the extent to which the patient has resolved the focal problem area. By reviewing why the patient is better, through the actions she has taken to resolve the interpersonal focus, the therapist reinforces the patient’s growing self-esteem by pointing out that the patient’s action shave led to her gains. The therapist congratulates the patient on her progress and hard work, and expresses optimism that the patient can maintain that progress independent of the therapist.:. Intervention 2: Control group: The control group participate in pre-test and post-test, but in order to respect the rights of individuals in the control group, interpersonal psychotherapy sessions will be perform for them.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Only primary variable tables and descriptive statistics of research members can be published</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Niloofar Rafiei Alhosaini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Robat St., after Ostad Shahriyar, 48th Alley</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8139887376</zip>
        <telephone>+98 31 3444 1894</telephone>
        <email>niloorafie74@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Niloofar Rafiei Alhosaini</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Robat St., after Ostad Shahriyar Alley, 48th Alley</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8139887376</zip>
        <telephone>+98 31 3444 1894</telephone>
        <email>niloorafie74@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a female gender
Having informed consent to participate in the study and sign the consent form
Collaboration with the researcher
Attending all intervention sessions
Having depression symptoms based on Beck scale</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>to be absent in 2 sessions of training intervention
Not willing to participate in the intervention
It is not possible to access them
Lack of significant depressive symptoms based on the Beck scale
Refusal to sign the consent and disagree on the treatment protocol</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: The reference of this protocol is: Comprehensive guide to interpersonal psychotherapy(Weissman, Markowitz&amp; Klerman, 2008), The guide to interpersonal psychotherapy(Weissman, Markowitz &amp; Klerman,2018),Interpersonal psychotherapy 2E a clinician's guide(Stuart &amp; Robertson,2012),Clinical handbook of psychological disorders: A step-by-step treatment manual(Barlow2014). Acute IPT treatment for major depression comprises initial, middle, and termination phases. And each session last50 to 60min(Barlow,2014): The Initial Phase (Sessions 1–3)Tasks of the initial sessions of IPT for major depression include eliciting the patient’s chief complaint; reviewing her symptoms and establishing a diagnosis; determining the interpersonal context for the current depressive episode; forming a therapeutic alliance; and setting the frame of the treatment, The Middle Phase (Sessions 4–9)Having made the treatment contract and chosen an interpersonal problem area as the focus of treatment, the therapist can proceed to the middle phase of sessions, in which the goal is to work on resolving the focal problem area. Each session begins with the question, “How have you been feeling since we last met?” This question elicits an interval history of mood, events, and interpersonal interactions that transpired between sessions. It also keeps the patient focused on current mood and situation. The patient is likely to respond by describing mood (“I felt really down”) or an event (“My husband and I had a huge fight”). After further inquiry, the therapist links the patient’s mood to a recent event, Oran event to her mood (“No wonder you felt depressed after the fight you had with your husband!”). The Termination Phase (Sessions 10–12)In the final sessions, the therapist reviews the patient's progress in symptom improvement, as well as the extent to which the patient has resolved the focal problem area. By reviewing why the patient is better, through the actions she has taken to resolve the interpersonal focus, the therapist reinforces the patient’s growing self-esteem by pointing out that the patient’s action shave led to her gains. The therapist congratulates the patient on her progress and hard work, and expresses optimism that the patient can maintain that progress independent of the therapist.:</i_keyword>
      <i_keyword>Control group: The control group participate in pre-test and post-test, but in order to respect the rights of individuals in the control group, interpersonal psychotherapy sessions will be perform for them.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression Signs. Timepoint: Before treatment and immediately after treatment sessions. Method of measurement: Beck Depression Inventory.</prim_outcome>
      <prim_outcome>Quality of Life. Timepoint: Before treatment and immediately after treatment sessions. Method of measurement: WHOQOL-BREF.</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>IR.IAU.KHSH.REC.1400.018</sec_id>
        <issuing_authority>سامانه ملی اخلاق در پژوهش های زیست پزشکی</issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-07-03</approval_date>
        <contact_name>National Ethics System in Biomedical Research- Islamic Azad University - Khomeini Shahr Branch (Rese</contact_name>
        <contact_address>Robat St., after Ostad Shahriyar, 48th Alley Isfahan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
