<?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>IRCT20210610051537N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-06-20</date_registration>
      <primary_sponsor>Self Funded</primary_sponsor>
      <public_title>Managing Stress for Academic Benefits through Mindfulness-Based Stress Reduction Therapy among University Students</public_title>
      <acronym>MBSR RCT 21</acronym>
      <scientific_title>Managing Stress for Academic Benefits through Mindfulness-Based Stress Reduction Therapy among University Students</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-09</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>120</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56880</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Following initial instruction with recruited groups, subjects were randomly allocated using randomization to one of the two groups. An online "clinical trial randomizer" (www.randomization.com) (Suresh, 2011) was conducted the treatment selection randomly.</study_design>
      <phase>2-3</phase>
      <hc_freetext>Academic Stress.</hc_freetext>
      <i_freetext>Intervention group: this group will take eight week training in Mindfulness Based Stress Reduction consisting of 2.5 hours of instruction per week and 45 minutes per day of home practice. The course will utilize the materials from palousemindfulness.com (permission has been sought and received from the site owner), which include video and written materials. Mindfulness practices include Mindful Eating, Body Scans, Focused Breathing and Gentle Yoga Poses. These are conducted during the sessions and in home practice tasks.  Maximum group numbers will be 10 per group. Each week participants will be given homework sheets to record their home practice; these will be collected and the times recorded as part of the data collection..</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:
After the study completion, the participant's data will be provided without identifying information.

When:
From Jan 2022

To whom:
Researchers of Mental Health Studies

Conditions:
For systematic reviews and meta analysis, studies are permitted.

Where to obtain:
Sewra Chowk 30 Feet Road, Hashmi Street 1. Email: maria.anwar.khan@gmail.com

How to obtain:
The data request needs to clearly define data needs. The study contact person will provide data with in a 2 weeks after receiving the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maria Anwar Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sewra Chowk Waryam Chowk, 30 Feet Street, Hashmi Street 1</address>
        <city>Multan</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 4782781</telephone>
        <email>maria.anwar.khan@gmail.com</email>
        <affiliation>The Islamia University, Bahawalpur</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maria Anwar Khan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sewra Chowk Waryam Chowk, 30 Feet Street, Hashmi Street 1</address>
        <city>MULTAN</city>
        <country1>Pakistan</country1>
        <zip>60000</zip>
        <telephone>+92 61 4782781</telephone>
        <email>maria.anwar.khan@gmail.com</email>
        <affiliation>The Islamia University, Bahawalpur</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age between 18- 30 years, therefore legally eligible to consent.
Students who will scored high stress on  academic stress scale.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Students who have not stress or mild stress
Students who are suffering from sever medical and neuropsychiatric complications or any psychotic illness
Students who will involve in any therapy.
The absence of over two sessions
Already completed mindfulness based stress reduction therapy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: this group will take eight week training in Mindfulness Based Stress Reduction consisting of 2.5 hours of instruction per week and 45 minutes per day of home practice. The course will utilize the materials from palousemindfulness.com (permission has been sought and received from the site owner), which include video and written materials. Mindfulness practices include Mindful Eating, Body Scans, Focused Breathing and Gentle Yoga Poses. These are conducted during the sessions and in home practice tasks.  Maximum group numbers will be 10 per group. Each week participants will be given homework sheets to record their home practice; these will be collected and the times recorded as part of the data collection.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>To measure Academic Stress. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: The Perception of Academic Stress Scale.</prim_outcome>
      <prim_outcome>To measure Mindfulness. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: Five Facet Mindfulness Questionnaire (FFMQ).</prim_outcome>
      <prim_outcome>To measure Academic Self Efficacy. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: Academic Self Efficacy Scale.</prim_outcome>
      <prim_outcome>To measure Academic Resilience. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: The Academic Resilience Scale.</prim_outcome>
      <prim_outcome>To measure Academic Burnout. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: Academic Burnout.</prim_outcome>
      <prim_outcome>To measure Academic Achievement. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: Academic Achievement.</prim_outcome>
      <prim_outcome>To measure Suicide Ideation. Timepoint: Baseline; after intervention, a 3 month follow up. Method of measurement: The Hopelessness and Suicide Ideation Inventory “IDIS”.</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>Self funded by researcher</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-02-26</approval_date>
        <contact_name>Department of Psychology Ethics Committee (DPEC) The Islamia University, Bahawalpur</contact_name>
        <contact_address>Baghdad ul Jadeed Capus, Hasilpur road, Bahawalpur, Pakistan. Bahawalpur Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
