<?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>IRCT20201001048893N7</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-11-16</date_registration>
      <primary_sponsor>Shiraz University of Medical Sciences</primary_sponsor>
      <public_title>The Comparison of positive psychotherapy via face to face vs. virtual reality on emotional experiences, life satisfaction and suicidal ideation of patients suffering from major depressive disorder, admited to hospital</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison of positive psychotherapy via face to face vs. virtual reality on emotional experiences, life satisfaction and suicidal ideation of patients suffering from major depressive disorder, admited to hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>78</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/66424</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, cluster controlled randomization method is used, where hospital departments (instead of individuals) will be considered as the randomization unit. In this study, random assignment of departments in the hospital will be done by someone outside the study using randomization software. In other words, the numbers of the sections will be entered into the randomization software, and this software will place the sections in one of the intervention or control groups completely randomly and by coding. The reason for choosing the cluster randomization method is to prevent and protect against data contamination that can occur in the randomization of people, Blinding description: In this study, in order to blind and prevent possible bias, interpretation of questionnaires and data entry and analysis will be done by someone outside the study. Also, the Beymazer clinical caregiver does not know how to assign people and the type of training of people. In order to prevent data contamination in this study, hospital departments will be randomized instead of individuals, and in fact, department numbers will be entered into the randomization software, and this software will be completely random and by coding the departments into one of two groups. control or intervention.</study_design>
      <phase>N/A</phase>
      <hc_freetext>major depressive disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Receiving three sessions of positive psychotherapy through virtual reality, including teaching positive psychotherapy modules such as forgiveness, kindness and gratitude. These trainings for the intervention group will be done by virtual reality glasses and software designed specifically for these glasses. By using these glasses, the patient will be placed in a 3D and virtual environment and will also hear the voice of the psychotherapist who communicates with him through the headset. The content of the mentioned century will be played three times for the patient on different days and the patient will complete the questionnaires before and after the intervention. Intervention 2: Control group: Receiving three sessions of positive psychotherapy including modules of kindness, gratitude and forgiveness in person and face to face.The patient will receive the mentioned trainings by the project's partner, a senior psychiatric nursing student, in person and in three sessions. These patients will also complete the questionnaires before and after the end of the intervention.</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 academic and scientific institutions

Conditions:
Systematic reviews and meta-analyses

Where to obtain:
Contact 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>Dr Maryam Shaygan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center</address>
        <city>Shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>13119–71936</zip>
        <telephone>+98 71 3647 4254</telephone>
        <email>m2620.shaygan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Maryam Shaygan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Iran, Shiraz, Namazi Square, Namazi Teaching Hospital, Fatemeh PBUH School of Nursing and Midwifery, Building 3, 2nd Floor, Community-based Psychiatric Care Research Center</address>
        <city>shiraz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>71936-13119</zip>
        <telephone>+98 71 3367 4254</telephone>
        <email>m2620.shaygan@gmail.com</email>
        <affiliation>Shiraz University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age above 18 years
Willingness to participate in the study
Ability to read and write at the fifth and sixth grade level
Having a diagnosis of major depression based on the psychiatrist's opinion (based on the information in the patient's file)
Having suicidal thoughts based on the information in the patient file and diagnostic interview screening questions (CIDI) by the senior psychiatric nursing student
Absence of psychotic symptoms in the patient
Not suffering from other mental disorders, including personality disorders, bipolar disorder or mental retardation, alcohol and substance abuse disorder, and dementia.
Not suffering from severe and debilitating chronic physical disease based on the information in the patient's file (such as cancer, hemodialysis, multiple sclerosis, etc.)
Preparation and favorable physical and mental conditions of the patient to participate in the intervention</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Refusal to continue participating in the study (during the study)
Occurrence of unexpected physical or mental problems during study
Inability to actively participate in the treatment process (for reasons such as slowness of thinking, slowness of speech, etc.)</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F33.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Major depressive disorder, recurrent severe without psychotic features</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Receiving three sessions of positive psychotherapy through virtual reality, including teaching positive psychotherapy modules such as forgiveness, kindness and gratitude. These trainings for the intervention group will be done by virtual reality glasses and software designed specifically for these glasses. By using these glasses, the patient will be placed in a 3D and virtual environment and will also hear the voice of the psychotherapist who communicates with him through the headset. The content of the mentioned century will be played three times for the patient on different days and the patient will complete the questionnaires before and after the intervention.</i_keyword>
      <i_keyword>Control group: Receiving three sessions of positive psychotherapy including modules of kindness, gratitude and forgiveness in person and face to face.The patient will receive the mentioned trainings by the project's partner, a senior psychiatric nursing student, in person and in three sessions. These patients will also complete the questionnaires before and after the end of the intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Positive and negative affect. Timepoint: Before and immediately after the intervention. Method of measurement: PANAS Emotional Experiences Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Life satisfaction. Timepoint: before and immediately after intervention. Method of measurement: satisfaction with life scale.</sec_outcome>
      <sec_outcome>Suicidal ideation. Timepoint: before and immediately after intervention. Method of measurement: suicidal cognition scale.</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 Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-09-10</approval_date>
        <contact_name>Ethics Committee in the Research of Nursing and Midwifery, Management and Medical Information-Shiraz</contact_name>
        <contact_address>School of Nursing and Midwifery, Nemazee Square, Zand St., Shiraz, Iran shiraz Fars Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
