<?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>IRCT20210505051182N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-30</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of the effectiveness of interpersonal psychotherapy on depression</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Interpersonal counselling and Interpersonal Psychotherapy on Emotional Expression, Social Skills and Depression Symptoms in Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>51</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56046</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly removed and the patient is assigned to the intervention or control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Depression.</hc_freetext>
      <i_freetext>Intervention 1: Interpersonal Counseling (IPC) is a concise, patient-centered approach to managing depression, which reduces the burden of primary care. This approach is a brief psychological intervention that lasts six or optionally seven 60-minute sessions. The main principle of IPC is that the symptoms of depression are related to interpersonal relationships. By affecting interpersonal relationships, depressive symptoms can be reduced in an optimistic and supportive way. The treatment manual is available through the WHO. This intervention was extracted directly from IPT to have a similar result with less cost and time. Intervention 2: Intervention group: Intervention group: Interpersonal psychotherapy is a treatment with a definite duration that is based on the treatment manual. IPT is performed according to the Interpersonal Psychotherapy Handbook for 12 90-minute weekly sessions. IPT treatment is based on the theory that depressive symptoms have multiple genetic and environmental causes. This treatment is the first line of non-pharmacological interventions for depression. Intervention 3: Control group: They will not receive any kind of intervention until one and three months after the end of the interventions on the two intervention groups 1 and 2. After the follow-up stage, one of the interventions 1 or 2, which is more effective, will be performed on the control group.</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:
All data is potentially shareable after de-identifying individuals

When:
The access period starts 12 months after the results are published

To whom:
It will be available only to researchers working in academic and scientific institutions

Conditions:
Those who want to do research in a similar field.

Where to obtain:
via this email:
o2_2227@yahoo.com
Respondent: Ahmed

How to obtain:
The applicant must send his plan so that if it matches the current research, the data file will be sent to him/her

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Javad Nezafat Ferizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molavi 1, Asrar1, Daneshgah 21</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9198933885</zip>
        <telephone>+98 51 3841 5483</telephone>
        <email>nezafatferizi@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Javad Nezafat Ferizi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Molovi1, Asrar 1, Daneshgah 21</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9198933885</zip>
        <telephone>+98 51 3841 5483</telephone>
        <email>nezafatferizi.j@iums.ac.ir</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>1- Achieving a score of 14 to 28 in Beck Depression Inventory
Minimum age 19 to 30 years
Not being undergoing psychiatric (pharmacological) and psychological treatments at the same time.</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe depressive disorder or bipolar disorder
Risk of suicide attempt before and during treatment.
Absence in two sessions of the treatment process.
Having severe mental disorders such as psychosis or severe personality disorders.</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent, mild</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Interpersonal Counseling (IPC) is a concise, patient-centered approach to managing depression, which reduces the burden of primary care. This approach is a brief psychological intervention that lasts six or optionally seven 60-minute sessions. The main principle of IPC is that the symptoms of depression are related to interpersonal relationships. By affecting interpersonal relationships, depressive symptoms can be reduced in an optimistic and supportive way. The treatment manual is available through the WHO. This intervention was extracted directly from IPT to have a similar result with less cost and time.</i_keyword>
      <i_keyword>Intervention group: Intervention group: Interpersonal psychotherapy is a treatment with a definite duration that is based on the treatment manual. IPT is performed according to the Interpersonal Psychotherapy Handbook for 12 90-minute weekly sessions. IPT treatment is based on the theory that depressive symptoms have multiple genetic and environmental causes. This treatment is the first line of non-pharmacological interventions for depression.</i_keyword>
      <i_keyword>Control group: They will not receive any kind of intervention until one and three months after the end of the interventions on the two intervention groups 1 and 2. After the follow-up stage, one of the interventions 1 or 2, which is more effective, will be performed on the control group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Symptoms of depression. Timepoint: Before interventions, after interventions, one and three months after interventions. Method of measurement: Beck Depression Inventory 2.</prim_outcome>
      <prim_outcome>Emotional Expression. Timepoint: Before interventions, after interventions, one and three months after interventions. Method of measurement: Emotional Expression Questionnaire.</prim_outcome>
      <prim_outcome>Social Skills. Timepoint: Before interventions, after interventions, one and three months after interventions. Method of measurement: Social Skills 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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-13</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Shahid Hemmat Highway Tehran 14496-14535, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
