<?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>IRCT20131112015390N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-04</date_registration>
      <primary_sponsor>Oroumia University of Medical Sciences</primary_sponsor>
      <public_title>The effect of using a smartphone application (Yara) on anxiety, suicidal thoughts and sleep quality in depressed patients</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of using a smartphone application (Yara) on anxiety, suicidal thoughts and sleep quality in patients with depression</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>64</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74444</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization was conducted by a simple random method via drawing a card inside a sealed envelope. In this way, thirty-two (A) cards and thirty-two (B) cards were placed inside the opaque and sealed envelope. For concealment, based on the research sample size, 64 envelopes are prepared with aluminum foil, and each randomly created sequence is recorded on a card. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the envelopes is sealed and placed in a box. Patients who were eligible to participate in the study randomly selected one of the sealed envelopes. Patients who chose card A were in the control group, and those who chose card B were in the intervention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Major depression.</hc_freetext>
      <i_freetext>Intervention group: Patients in the intervention group will use the researcher-made application (Yara) for three months. The Yara application will be designed and built by a computer software engineer in collaboration with the research team to help depressed patients..</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

When:
6 months after publication

To whom:
For all researchers in other organizations

Conditions:
Any type of analysis is allowed.

Where to obtain:
To the email of the person responsible for the study

How to obtain:
It must be requested in writing and via email.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeynab Soltani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First building on the right, Jabraben Hayan St., Shahid Dr. Qalipur St., Ibn Sina St, 11 km Saro Road, School of Nursing and Midwifery, West Azarbaijan, Urmia.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115335</zip>
        <telephone>+98 44 3275 4961</telephone>
        <email>soltani.zeinab.93@gmail.com</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Naser Parizad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>First building on the right, Jabraben Hayan St., Shahid Dr. Qalipur St., Ibn Sina St, 11 km Saro Road, School of Nursing and Midwifery, West Azarbaijan, Urmia.</address>
        <city>Urmia</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5756115335</zip>
        <telephone>+98 44 3223 4897</telephone>
        <email>parizad.n@umsu.ac.ir</email>
        <affiliation>Oroumia University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Having smartphone
Diagnosis of depression by DSM-5 criteria
Being literate</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Patients in the intervention group will use the researcher-made application (Yara) for three months. The Yara application will be designed and built by a computer software engineer in collaboration with the research team to help depressed patients.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The mean anxiety score using the Spielberger State-Trait Anxiety Inventory (STAI),. Timepoint: Measuring anxiety at the beginning of the study (before the study started) and after the study was completed. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI);.</prim_outcome>
      <prim_outcome>The mean sleep quality score using the Petersburg Sleep Quality Questionnaire. Timepoint: Measuring sleep quality at the beginning of the study (before the study started) and after the study was completed. Method of measurement: Pittsburgh Sleep Quality Index (PSQI);.</prim_outcome>
      <prim_outcome>The mean score of suicidal thoughts using the Beck Suicidal Thoughts Questionnaire. Timepoint: Measuring suicidal thoughts at the beginning of the study (before the study started) and after the study was completed. Method of measurement: Beck Scale for Suicidal Ideation (BSSI).</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>Oroumia University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-05-26</approval_date>
        <contact_name>Ethics Committee of Urmia University of Medical Sciences</contact_name>
        <contact_address>Emergency alley, Resalat Boulevard, Urmia University of Medical Sciences, Urmia. Urmia West Azarbaijan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
