<?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>IRCT20201031049206N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-01-13</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Design, implementation and evaluation of screening and self-care software for minor depression</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of the effect of minor depression self-care software on the severity of depression among students of Mazandaran University of Medical Sciences</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53402</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple individual randomization method with flipping coins will be used.
Randomization tool: SAS statistical software.
We will use the website to create a random sequence.
We will use the central randomization method (email) for allocation concealment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Mild depression.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Students install the software on their smartphone and complete the PHQ-9 questionnaire. If they have a mild depression, they are invited to use the software. Participants will follow the assignments provided in the software for 4 weeks (4 sessions, each session is two weeks). The proposed intervention includes a combination of basic cognitive-behavioral therapy and self-regulatory therapy. The tasks are the worksheets and concepts of these two treatments.In the first session, the user will be given tasks to improve self-awareness and tools for daily planning.Our goal in the second session is behavioral activation,Identify lost activities, and prevent idealism.In the third session, we increase the areas of activity and the number of activities of the behavioral activation worksheet and lead the user to choose promotion activities, we will identify users areas of life that have promotion or deterrence goals, we will identify the person's negative thoughts.In the final session, we will extend behavioral activation to various areas of the user's life, we will replace negative thoughts with logical ones, and by determining the costs and benefits of perfectionist thoughts, we will prepare the user to reconsider and determine realistic thoughts, we will also determine the cost-effectiveness of this changes for each of their goals.At the end of each session, the severity of their depression will be measured by the PHQ-9 questionnaire. Intervention 2: Control group: The rest of the students whose mild depression was confirmed by the questionnaire will be grouped in the control group.These students will not be subject to any intervention and we will receive their depression severity at the end of each week (4 weeks) via email.</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 I haven't decided yet - the release schedule is still unknown.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saeed Barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Ostad Shahriyar Alley, First 12 Meter Alley</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451773979</zip>
        <telephone>+98 41 4423 7355</telephone>
        <email>barz_saeed@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Saeed Barzegari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 27, Ostad Shahriyar Alley, First 12 Meter Alley</address>
        <city>Ahar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5451773979</zip>
        <telephone>+98 41 4423 7355</telephone>
        <email>barz_saeed@yahoo.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>En Be a student of Mazandaran University of Medical Sciences.
According to PHQ-9 tool have minor depression.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>26 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Taking sedatives
Dissatisfaction
Underlying diseases such as hypothyroidism and ...
History of self-harm
History of suicide</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32.8</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other depressive episodes</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Students install the software on their smartphone and complete the PHQ-9 questionnaire. If they have a mild depression, they are invited to use the software. Participants will follow the assignments provided in the software for 4 weeks (4 sessions, each session is two weeks). The proposed intervention includes a combination of basic cognitive-behavioral therapy and self-regulatory therapy. The tasks are the worksheets and concepts of these two treatments.In the first session, the user will be given tasks to improve self-awareness and tools for daily planning.Our goal in the second session is behavioral activation,Identify lost activities, and prevent idealism.In the third session, we increase the areas of activity and the number of activities of the behavioral activation worksheet and lead the user to choose promotion activities, we will identify users areas of life that have promotion or deterrence goals, we will identify the person's negative thoughts.In the final session, we will extend behavioral activation to various areas of the user's life, we will replace negative thoughts with logical ones, and by determining the costs and benefits of perfectionist thoughts, we will prepare the user to reconsider and determine realistic thoughts, we will also determine the cost-effectiveness of this changes for each of their goals.At the end of each session, the severity of their depression will be measured by the PHQ-9 questionnaire.</i_keyword>
      <i_keyword>Control group: The rest of the students whose mild depression was confirmed by the questionnaire will be grouped in the control group.These students will not be subject to any intervention and we will receive their depression severity at the end of each week (4 weeks) via email.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression score in PHQ-9 questionnaire. Timepoint: Before the intervention, 7, 14, and 21 days after the start of the intervention. Method of measurement: PHQ-9 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>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-06-19</approval_date>
        <contact_name>Ethics Committee of School of Health and Paramedical Sciences - Tehran University of Medical Science</contact_name>
        <contact_address>No. 17, Fardanesh Alley, Ghods St., Enghelab St., Enghelab Sq., Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
