<?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>IRCT20230417057932N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-10</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effectiveness of cognitive- behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being and Social Adjustment in students with generalized anxiety disorder</public_title>
      <acronym>اثربخشی آموزش مدیریت استرس به شیوه شناختی رفتاری</acronym>
      <scientific_title>The effectiveness of cognitive-behavioral stress management training on emotion regulation strategies, life expectancy, mental well-being and Social Adjustment in students with generalized anxiety disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74429</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Generalized anxiety disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:Intervention group: In this study, the cognitive-behavioral stress management training protocol is used for the intervention group. The first session: description of stressors and responses to them, awareness of possible health consequences, introduction of the protocol to the participants, awareness of the physical effects of stress, muscle relaxation for 16 muscle groups. The second session: the effect of stress on emotions and behavior, awareness of the effect of stress on thoughts, muscle relaxation for 8 muscle groups. Third session: communication of thoughts and emotions, awareness of imaging technique, diaphragmatic breathing, muscle relaxation for 4 muscle groups. The fourth session: identifying negative thoughts and cognitive distortions, solutions to challenge negative thoughts, visualization and passive muscle relaxation, the fifth session: replacing logical thoughts with illogical ones, spontaneous training to feel heaviness and warmth. Sixth session: training to cope effectively with stress, spontaneous training for heart rate, breathing, abdomen and forehead. Seventh session: Implementation of effective countermeasures of self-generated training along with visualization and self-induction. Session 8: Anger management training and mantra meditation, repetition and meditation practice. Ninth session: Teaching expressiveness in interpersonal relationships, breathing counting meditation. Session 10: Social support and social network maintenance techniques, creating a personal stress management plan. Intervention 2: Control group: In this study, the control group participated in the pre-test, post-test and follow-up, but no educational or psychological intervention was implemented for this group.</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:
In this study, an intervention program, including sessions accompanied by grade margins, is presented during the pre-test, post-test, and follow-up stages without specifying the participants' names. Additionally, the final results are disclosed.

When:
After one month from the publication of the results.

To whom:
for everyone

Conditions:
It is not necessary conditions.

Where to obtain:
email

How to obtain:
1 Month

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Anvar Dastbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Anvardastbaz@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Anvar Dastbaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 64, Kurdistan of University, Pasdaran Blvd., Sanandaj, Iran.</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6617715175</zip>
        <telephone>+98 87 3366 4600</telephone>
        <email>Anvardastbaz@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Middle school student and attendance at school during the research period
being between the ages of 14-18 years
Having generalized anxiety disorder (diagnosed based on the Spitzer Generalized Anxiety Disorder Questionnaire by Spitzer Et al. (2006) and an interview conducted by an experienced psychologist according to the criteria of DSM-5-TR).</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>presence of a chronic and disabling disease
presence of concurrent mental disorders
Participation in similar courses with an independent variable in the past or concurrently.
Consumption of Psychiatric Medications</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F41.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Generalized anxiety disorder</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:Intervention group: In this study, the cognitive-behavioral stress management training protocol is used for the intervention group. The first session: description of stressors and responses to them, awareness of possible health consequences, introduction of the protocol to the participants, awareness of the physical effects of stress, muscle relaxation for 16 muscle groups. The second session: the effect of stress on emotions and behavior, awareness of the effect of stress on thoughts, muscle relaxation for 8 muscle groups. Third session: communication of thoughts and emotions, awareness of imaging technique, diaphragmatic breathing, muscle relaxation for 4 muscle groups. The fourth session: identifying negative thoughts and cognitive distortions, solutions to challenge negative thoughts, visualization and passive muscle relaxation, the fifth session: replacing logical thoughts with illogical ones, spontaneous training to feel heaviness and warmth. Sixth session: training to cope effectively with stress, spontaneous training for heart rate, breathing, abdomen and forehead. Seventh session: Implementation of effective countermeasures of self-generated training along with visualization and self-induction. Session 8: Anger management training and mantra meditation, repetition and meditation practice. Ninth session: Teaching expressiveness in interpersonal relationships, breathing counting meditation. Session 10: Social support and social network maintenance techniques, creating a personal stress management plan.</i_keyword>
      <i_keyword>Control group: In this study, the control group participated in the pre-test, post-test and follow-up, but no educational or psychological intervention was implemented for this group.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion Regulation Strategies. Timepoint: Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention). Method of measurement: Emotion regulation scale (Gross and Jones, 2003).</prim_outcome>
      <prim_outcome>Life Expectancy. Timepoint: Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention). Method of measurement: Miller Hope Scale (1988).</prim_outcome>
      <prim_outcome>Mental Well-Being. Timepoint: Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention). Method of measurement: Mental well-being questionnaire (Keyes &amp; Magyar-Moe, 2003).</prim_outcome>
      <prim_outcome>Social Adjustment. Timepoint: Pre-test (before the intervention), post-test (after the intervention), follow-up (2 months after the intervention). Method of measurement: California Social Adjustment Questionnaire (Clark et al.,1993).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-07-11</approval_date>
        <contact_name>Research Ethics Committees of Islamic Azad University-Sanandaj Branch</contact_name>
        <contact_address>Sanandaj - Adab St. - central site of Islamic Azad University, Sanandaj branch Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
