<?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>IRCT20210424051070N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-06</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>"The effect of metacognitive sterategies training on the  health anxiety and mental health of students"</public_title>
      <acronym></acronym>
      <scientific_title>The effect of metacognitive sterategies training on the  health anxiety and mental health of students.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-08-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>56</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/55990</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: For randomization, the permutation random blocking method is used. In this method, 14 blocks of 4 from a combination of letters A and B will be randomly selected. These blocks are AABB, ABBA, BBAA, BAAB, ABAB, BABA. The blocks are selected in such a way that the following numbers are assigned to the blocks:
1:AABB
2:ABBA
3:BBAA
4:BAAB
5:ABAB
6:BABA
Then 14 one-digit random numbers are selected from the table of random numbers. If the number 7 8 9 is among these digits, they will be deleted. In this way, 14 blocks are selected. Assigning the letters A and B to the intervention and control groups will be done randomly before randomization and the data analyst will be unaware of the intervention and control groups. Having a list of people (a list of 56 people who are going to participate in the project), the researcher assigns a numeric code to each person. It then provides the anonymous list of members (containing only the numeric code) to the sample assignor to the groups. The sample assignee to the groups first prepares the selected blocks as described, writes them on separate sheets of paper (14 separate sheets), and places them in sealed envelopes. It then randomly selects the envelopes and, based on the previously selected codes A and B, determines the numerical code number of the individuals assigned to intervention A and B and provides it to the researcher. For example, if the BABA block is selected first, the first person on the list will be assigned to group B, the second person to group A, the third person to group B, and the fourth person to group A. Similarly, person 5 to 56 will be assigned to groups A and B.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Anxiety and mental health of students.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Teaching metacognitive strategies in 8 sessions for one hour twice a week.The content of the meetings is as follows:Session 1: Welcoming and getting to know the members, introducing the members to each other, getting to know the rules of the group and the training course, explaining the goals, introducing metacognitive intervention             Session 2: Familiarity with the metacognitive model of beliefs related to uncontrollable anxiety,Homework: Paying attention to dissociative awareness and postponing worry     Session 3: Uncontrollable verbal and behavioral re-documentation,Homework: Continue to postpone the concern and introduce the loss control test and introduce the loss test     Session 4: Identify and stop mismatch control avoidance behaviors,Homework: Continue to procrastinate and try to lose control                                                                                       Session 5: Challenging Beliefs Related to Uncontrollable Anxiety - Challenging Negative Beliefs Related to the Danger of Worry,Homework: A test of intentional anxiety to assess whether anxiety is dangerous                                                                                                  Session 6: Challenging Negative Beliefs Related to the Danger of Concern_Experimenting,Homework: Behavioral tests to challenge beliefs related to the dangers of worry                                                                                                                       Session 7: Challenging with positive metacognitive beliefs,Homework: An inconsistent strategy or other experiment to challenge positive metacognitive beliefs                          Session 8: Summary of treatment and completion of treatment planHomework: Specify the continuity of use . Intervention 2: Control group: The control group does not receive any 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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the dissatisfaction of the research participants with the publication of the results, the results will not be published.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nafise nouri Siahdasht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaghani19, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9194966973</zip>
        <telephone>+98 58 3646 0106</telephone>
        <email>nourisn981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nafise nouri Siahdasht</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khaghani19, Mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9194966973</zip>
        <telephone>+98 58 3646 0106</telephone>
        <email>nourisn981@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Student of Mashhad university of medical science
Absence of psychiatric disorder( A short interview is conduct edwith each person to ensure that there is no disorder)
Absence of effective physical disorder
Having conscious satisfaction from participating in research
Age range 18-30 year</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>acute psychiatric disorder that makes it difficult to participate in treatment (such as bipolar disorder, major depression, psychotic disorders, suicide attempt).
Participate in similar training programs in the last 6 months</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>N/A</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Teaching metacognitive strategies in 8 sessions for one hour twice a week.The content of the meetings is as follows:Session 1: Welcoming and getting to know the members, introducing the members to each other, getting to know the rules of the group and the training course, explaining the goals, introducing metacognitive intervention             Session 2: Familiarity with the metacognitive model of beliefs related to uncontrollable anxiety,Homework: Paying attention to dissociative awareness and postponing worry     Session 3: Uncontrollable verbal and behavioral re-documentation,Homework: Continue to postpone the concern and introduce the loss control test and introduce the loss test     Session 4: Identify and stop mismatch control avoidance behaviors,Homework: Continue to procrastinate and try to lose control                                                                                       Session 5: Challenging Beliefs Related to Uncontrollable Anxiety - Challenging Negative Beliefs Related to the Danger of Worry,Homework: A test of intentional anxiety to assess whether anxiety is dangerous                                                                                                  Session 6: Challenging Negative Beliefs Related to the Danger of Concern_Experimenting,Homework: Behavioral tests to challenge beliefs related to the dangers of worry                                                                                                                       Session 7: Challenging with positive metacognitive beliefs,Homework: An inconsistent strategy or other experiment to challenge positive metacognitive beliefs                          Session 8: Summary of treatment and completion of treatment planHomework: Specify the continuity of use .</i_keyword>
      <i_keyword>Control group: The control group does not receive any intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Health anxiety. Timepoint: Beginning and end of the intervention. Method of measurement: Salkovskis and Warwick Health Anxiety Questionnaire.</prim_outcome>
      <prim_outcome>Mental health. Timepoint: Beginning and end of the intervention. Method of measurement: GHQ-28 General Health 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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-13</approval_date>
        <contact_name>Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>University Street, next to Hoveyzeh Cinema, Ghorashi Building, Deputy of Research and Technology Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
