<?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>IRCT20260720070267N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-13</date_registration>
      <primary_sponsor>Saveh University of Medical Sciences</primary_sponsor>
      <public_title>Investigating the effect of digital cognitive behavioral training on the professional ethics</public_title>
      <acronym>CBT</acronym>
      <scientific_title>Investigating the effect of digital cognitive behavioral training on the professional ethics of medical students during their psychology internship (an interventional study)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>38</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/94010</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Given that academic semester and field of study can affect the results of the study as a confounding variable, block randomization will be used to randomly assign participants. For this purpose, first, all 32 eligible participants are divided into two separate blocks based on their field of study, including nursing and emergency medicine students. Then, the random assignment process to the intervention and control groups is carried out separately within each block. In each block, each participant is assigned a unique identification code (from 1 to the number of people in that block). Using a random number table and starting from a random point, the numbers are read in order. If the number is even, the person is assigned to the intervention group and if it is odd, the person is assigned to the control group. This process continues until all people in that block are assigned.Finally, in each block, an approximately equal number of students (half to the intervention and half to the control) will be assigned, and a total of two intervention and control groups will be formed with an identical structure in terms of semester and field of study.Coding of intervention and control groups: There will be two intervention and control groups in this study, each of which will also be coded for random assignment:
: A Intervention (receiving the usual training of the psychiatric ward internship (such as psychiatric interview, learning about medications and giving medications, nursing diagnosis, and preparing the nursing process in the psychiatric ward) and digital CBT training)
: B Control (receiving the usual training of the psychiatric ward internship (such as psychiatric interview, learning about medications and giving medications, nursing diagnosis, and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training)
To ensure allocation concealment, the process of generating and maintaining the final allocation list will be carried out by an independent colleague who has no role in the intervention and evaluation stages.
The implementation of the training will be carried out after the group of training sessions is determined according to the predetermined protocols for the intervention group.All participants in the intervention group will enter the group and educational channel via a link and receive digital cognitive behavioral training, and student movement between groups will be prevented to minimize the risk of educational contamination.
Evaluation schedule: The assessment of the professional ethics variable will be conducted in 3 stages: Pre-test: before the start of the educational intervention Post-test: after the complete completion of the educational sessions and follow-up will be held one month after the last educational session.
In order to comply with ethical issues and the absence of discrimination between the intervention and control groups, relevant training and educational materials will also be provided to the control group after taking the follow-up test, Blinding description: Participants do not know whether they are in the intervention or control group. The analyst receives the data in numerical, encrypted form and does not know the information about each group.</study_design>
      <phase>3</phase>
      <hc_freetext>professional ethics.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: (Receiving standard training for psychiatric internships (such as psychiatric interviews, learning about medications and giving medications, nursing diagnosis, and preparing nursing processes in the psychiatric ward) and digital CBT training). Intervention 2: Control group: (Receiving the usual training of the psychiatric ward internship (such as psychiatric interview - learning about medications and giving medications, nursing diagnosis and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training).</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:
The data is provided anonymously and without any mention of it

When:
Access period begins 6 months after results are published

To whom:
For researchers working in academic and scientific institutions, submit an application via

Conditions:
Submit a request via email

Where to obtain:
Email

How to obtain:
Email will be responded to immediately upon request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>زینب پیراللهی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi Town, Ghaem Street, Alley 4</address>
        <city>saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914794881</zip>
        <telephone>+98 86 4248 3166</telephone>
        <email>zeynabpirallahi@gmail.com</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>زینب پیراللهی</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Alavi Town, Ghaem Street, Alley 4</address>
        <city>saveh</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3914794881</zip>
        <telephone>+98 86 4248 3166</telephone>
        <email>zeynabpirallahi@gmail.com</email>
        <affiliation>Saveh University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Willingness to participate in the study
Students' access to the digital education program and channel via mobile phone</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Failure to fully participate in training sessions
Unwillingness to continue participating in any phase of the study
The occurrence of illness or special circumstances (personal or professional) that prevent continued participation in the study
Previous experience in formal or specialized training in mental health management within the last six months
Simultaneous participation in similar educational courses or related research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>XXI</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>XXI</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: (Receiving standard training for psychiatric internships (such as psychiatric interviews, learning about medications and giving medications, nursing diagnosis, and preparing nursing processes in the psychiatric ward) and digital CBT training)</i_keyword>
      <i_keyword>Control group: (Receiving the usual training of the psychiatric ward internship (such as psychiatric interview - learning about medications and giving medications, nursing diagnosis and preparing the nursing process in the psychiatric ward) and not receiving digital CBT training)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Professional ethics. Timepoint: Before training - Immediately after the last training session - One month after the last training session. Method of measurement: Professional ethics 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>Saveh University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-08-18</approval_date>
        <contact_name>Student Research Committee, Saveh University of Medical Sciences, Saveh, Iran</contact_name>
        <contact_address>کمیته تحقیقات دانشجویی، دانشگاه علوم پزشکی ساوه، ساوه، ایران saveh Markazi Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
