<?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>IRCT20210622051664N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-24</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of mobile -based Logotherapy on depressive symptoms, suicidal ideation and hoplessness  in patients with major depressive disorder</public_title>
      <acronym></acronym>
      <scientific_title>Investigating the effect of mobile -based Logotherapy on depressive symptoms, suicidal ideation and hoplessness  in patients with major depressive disorder reffered to clinics affiliated with Shiraz University of Medical Sciences,1400</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-07-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/57032</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple random method using randomization software (from software
Random allocation).
  First, the list of participants is obtained, then each of them is assigned a score or number, and using simple randomization software and using a table of random numbers, participants are divided into two groups, Blinding description: Study participants, statistical analysts, and questionnaire reviewers will have no information about the status of individuals in the groups and the type of training provided in the groups.
Participants in the groups have no knowledge of whether they are in the experimental or control group. Participants only know that they are receiving training but are not aware of the type of intervention they are receiving. Researchers, statistical analysts, and questionnaire reviewers are also unaware of the type of intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Condition 1: Depression. Condition 2: suicidal ideations.</hc_freetext>
      <i_freetext>Intervention 1: Control group: The control group will remain on the waiting list until the end of the study and will receive only sertraline drug therapy training. Intervention 2: Intervention group:  Receive semantic therapy training. The purpose of semantic therapy in this study is to provide 8 semantic therapy training packages in 8 consecutive weeks for patients with major depression based on the treatment methods suggested by Frankel and his followers, taken from The book "Man in Search of Meaning" is presented. Participants will receive 8 semantic therapy training packages in 8 weeks by attending the virtual group via mobile and WhatsApp program. The content of these training packages will be a collection of texts, sounds, images and educational videos. Which will be available to people on a daily basis.</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:
Anonymous study data will be shared in correspondence with the project manager

When:
Access period starts 6 months after the results are published

To whom:
Researchers working in scientific and academic institutions

Conditions:
A closer look at the data of patients with major depression

Where to obtain:
Correspondence via email

How to obtain:
After obtaining permission from the security unit and the university's vice chancellor for research, the data will be made available to the individual.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Marzieh Shemiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No3.3rd floor.saeed bulding.16th Alley.20 meters from Imam Khomeini Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7178897901</zip>
        <telephone>+98 71 3824 2810</telephone>
        <email>farzanehsh80@email.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Marzieh Shemiran</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No3.3rd floor.saeed bulding.16th Alley.20 meters from Imam Khomeini Street</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7178897901</zip>
        <telephone>+98 71 3824 2810</telephone>
        <email>farzanehsh80@email.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a diagnosis of major depression based on the opinion of a psychiatrist according to DSM-V criteria
Having a depression score of 8 or higher based on the short form of the Beck Depression Inventory
Have a  hoplessness score of 9 or higher based on the Beck Disappointment Questionnaire
Having suicidal ideation based on Beck Suicide Thought Questionnaire screening questions
Start treatment with the antidepressant drug sertraline based on a psychiatrist's prescription
Internet accessible mobile phone</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Reluctance to participate in the study
Presence of psychotic symptoms in the patient
Having other chronic mental disorders such as personality disorders, bipolar disorder or mental retardation in the patient
Having chronic physical illnesses such as diabetes or MS
Unforeseen physical or mental problems during the intervention
Taking other antidepressants except sertraline by the patient
The need to hospitalize the patient for any reason, including the high risk of suicide in the patient according to the psychiatrist
Incompetence in completing the consent form (such as lack of knowledge of the time, place, person and the presence of psychotic symptoms)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F32</hc_code>
      <hc_code>R45.851</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, single episode</hc_keyword>
      <hc_keyword>Suicidal ideations</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: The control group will remain on the waiting list until the end of the study and will receive only sertraline drug therapy training.</i_keyword>
      <i_keyword>Intervention group:  Receive semantic therapy training. The purpose of semantic therapy in this study is to provide 8 semantic therapy training packages in 8 consecutive weeks for patients with major depression based on the treatment methods suggested by Frankel and his followers, taken from The book "Man in Search of Meaning" is presented. Participants will receive 8 semantic therapy training packages in 8 weeks by attending the virtual group via mobile and WhatsApp program. The content of these training packages will be a collection of texts, sounds, images and educational videos. Which will be available to people on a daily basis.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression. Timepoint: Before the intervention, immediately after the intervention, 3 months later. Method of measurement: Beck Depression Inventory: BDI-11.</prim_outcome>
      <prim_outcome>Hoplessness. Timepoint: Before the intervention, immediately after the intervention, 3 months later. Method of measurement: Beck hopelessness scale(BHS).</prim_outcome>
      <prim_outcome>Suicidal thoughts. Timepoint: Before the intervention, immediately after the intervention, 3 months later. Method of measurement: Beck Scale for Suicide 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>Shiraz University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-19</approval_date>
        <contact_name>Ethics committee of Shiraz University of Medical Sciences</contact_name>
        <contact_address>Karim Khan Zand St., in front of Palestine St., the central building of Shiraz University of Medical Sciences and Health Services Shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
