<?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>IRCT20171009036661N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-01-16</date_registration>
      <primary_sponsor>Kerman University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the Effects of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy(iACT) on Mental health and Mindfulness</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effects of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy(iACT) on Mental health and Mindfulness of Medical Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-12</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65842</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: In this study, the method of selecting people will be simple random sampling. In this way, we number the list of names of the students who are going to enter the study from 1 to the last (60) and record each of the numbers on similar and identical small cards. Then we put all the cards in a box and every time after shaking the box, we randomly take out one card from the box and record its number. We continue this process until the number of 20 people is obtained. We put these people in the ICBT group. Then, after shaking the box, we take out another 20 cards and record their number. The names of the 20 cards removed will be considered as the iACT group, and the names of the 20 cards remaining in the box will be considered as the control group, Blinding description: In this study, main investigator and outcome assessor were blinded. The data analyser were also blinded because all checklist was without name and contained only a code.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effect of Internet Cognitive-Behavioral Therapy (ICBT) and Internet Acceptance and Commitment Therapy (iACT) on mental health and mindfulness.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: people undergoing Internet cognitive-behavioral therapy/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: Internet cognitive-behavioral therapy according to the discretion of the expert who organized the course. Intervention 2: Intervention group (second): people undergoing treatment based on acceptance and commitment on the Internet/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: acceptance and commitment on the Internet therapy according to the discretion of the expert who organized the course. Intervention 3: Control group: people who do not undergo any treatment.</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 No more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Massoud mayel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Shahid Bahonar hospital, Qarani st.</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>masoud.mayel@gmail.com</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Massoud mayel</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emergency Medicine Department - Shahid Bahonar Hospital - Kerman - IRAN</address>
        <city>Kerman</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7613747181</zip>
        <telephone>+98 34 3223 5011</telephone>
        <email>masoud.mayel@gmail.co</email>
        <affiliation>Kerman University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Medical students of Kerman University of Medical Sciences during internships in 2022
Proficiency in Persian language</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Guest students at Kerman University of Medical Sciences
concurrent participation in another psychiatric intervention
history of mental illness, being treated by a psychiatrist, taking psychiatric drugs
Lack of proper access to social networks
Lack of consent to continue the treatment process</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F48.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nonpsychotic mental disorder, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: people undergoing Internet cognitive-behavioral therapy/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: Internet cognitive-behavioral therapy according to the discretion of the expert who organized the course</i_keyword>
      <i_keyword>Intervention group (second): people undergoing treatment based on acceptance and commitment on the Internet/ Duration of treatment: 2 months/ How to hold: online/ Number of sessions: 8 sessions (4 sessions per month)/ Duration of sessions: 1 hour/ Content: acceptance and commitment on the Internet therapy according to the discretion of the expert who organized the course</i_keyword>
      <i_keyword>Control group: people who do not undergo any treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mental health. Timepoint: 2 months after the start of the intervention. Method of measurement: GHQ mental health scale.</prim_outcome>
      <prim_outcome>Mindfulness. Timepoint: 2 months after the start of the intervention. Method of measurement: Five-faceted Mindfulness Questionnaire (FFMQ).</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>Kerman University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-08-09</approval_date>
        <contact_name>Research Ethics Committee of Kerman University of Medical Sciences</contact_name>
        <contact_address>Kerman University of Medical Sciences, Medical University Campus,     Haft-Bagh Highway, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
