<?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>IRCT2016050627756N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2016-08-14</date_registration>
      <primary_sponsor>University of Putra Malaysia</primary_sponsor>
      <public_title>STRESS, ANXIETY AND DEPRESSION AMONG PRECLINICAL MEDICAL STUDENTS OF UNIVERSITI PUTRA MALAYSIA AND THE EFFECT OF MINDFULNESS ON DASS-21 SCORES</public_title>
      <acronym></acronym>
      <scientific_title>STRESS, ANXIETY AND DEPRESSION AMONG PRECLINICAL MEDICAL STUDENTS OF UNIVERSITI PUTRA MALAYSIA AND THE EFFECT OF MINDFULNESS ON DASS-21 SCORES</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2014-01-18</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>112</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/22673</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: A baseline cross sectional study is conducted to determine the students with high stress, anxiety and depression scores.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress, Anxiety and Depression.</hc_freetext>
      <i_freetext>Intervention 1: The intervention group will receive the One-Day Mindfulness program (ODM) which consist of two sessions (Morning and afternoon sessions)&#13;
The morning session explains the ABC of stress, anxiety and depression (SAD). It explains the definition, and types. Then the basic mechanism and the benefit of mindfulness will be explained. Students will be trained in Mindful Stretching &amp; Muscle Relaxation as well as a training to anchor attention by labeling their actions and to pay attention to hearing, touching and seeing (HTC Method) the surrounding environment to help them appreciate it. Students are trained also in deep and mindful breathing as well as mindful imagery. The afternoon session included teaching the student on how to apply mindfulness in their daily life in order to Transform their thoughts (especially the negative one) into happy one. The session will involve a movie, a song and the application of mindful STOP technique which enabled the students to access mindfulness anytime and anywhere. Intervention 2: The control group is the wait-listed group and they will receive the intervention at the end of the study.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Maher D. Fuad Fuad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>K-10-3A Subang Olives Residence, Jalan kemajuan Subnag, SS16</address>
        <city>Subang Jaya</city>
        <country1>Malaysia</country1>
        <zip>47500</zip>
        <telephone>0060350366626</telephone>
        <email>maherazawi@gmail.com</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Maher D. Fuad Fuad</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>K-10-3A Subang Olives resoidence, jalan kemajuan Subang, SS16</address>
        <city>Subang Jaya</city>
        <country1>Malaysia</country1>
        <zip>47500</zip>
        <telephone>0060350366626</telephone>
        <email>maherazawi@gmail.com</email>
        <affiliation>Universiti Putra Malaysia</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Malaysia</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria: Students with mild, moderate and high distress scores; Preclinical undergraduate medical students; Willing to participate&#13;
Exclusion Criteria:Students who do not give their consent to participate in the study; Clinical undergraduate students; Extremely severe distress scores will be referred to psychiatrist evaluation.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z56.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stressful work schedule</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Placebo</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The intervention group will receive the One-Day Mindfulness program (ODM) which consist of two sessions (Morning and afternoon sessions)&#13;
The morning session explains the ABC of stress, anxiety and depression (SAD). It explains the definition, and types. Then the basic mechanism and the benefit of mindfulness will be explained. Students will be trained in Mindful Stretching &amp; Muscle Relaxation as well as a training to anchor attention by labeling their actions and to pay attention to hearing, touching and seeing (HTC Method) the surrounding environment to help them appreciate it. Students are trained also in deep and mindful breathing as well as mindful imagery. The afternoon session included teaching the student on how to apply mindfulness in their daily life in order to Transform their thoughts (especially the negative one) into happy one. The session will involve a movie, a song and the application of mindful STOP technique which enabled the students to access mindfulness anytime and anywhere.</i_keyword>
      <i_keyword>The control group is the wait-listed group and they will receive the intervention at the end of the study.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Stress and Anxiety. Timepoint: Baseline and after 8 weeks. Method of measurement: DASS-21 and GHQ-12.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Depression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: PHQ-9, SSKM-20.</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>University of Putra Malaysia</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2013-08-26</approval_date>
        <contact_name>Research ethics Committee of the Universiti Putra Malaysia (JKEUPM)</contact_name>
        <contact_address>Pejabat Timbalan Naib Canselor (penyedidikan dan Inovasi) Universiti Putra Malaysia Serdang Selangor Malaysia</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
