<?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>IRCT20201007048963N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-04-22</date_registration>
      <primary_sponsor>Navid Zandegi Help Clinic</primary_sponsor>
      <public_title>The effect of stress on adolescent addiction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effectiveness of mindfulness-based stress reduction and emotion regulation training on addiction readiness, excitement and anxiety tolerance in adolescents with addicted parents in Ahvaz</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-04-13</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/53911</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance.</study_design>
      <phase>N/A</phase>
      <hc_freetext>The effectiveness of mindfulness-based stress reduction on tolerating anxiety and excitement.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Mindfulness-based stress reduction therapy for 8 sessions per week, one 60-minute session per week according to Kabat Zayn (2003). With each other and with the rules of the group, specify the goals and expectations of treatment, explain the nature of addiction and talk to group members about addiction and its effects on their life dimensions, brief introduction of mindfulness, raisin eating practice, body exam, mindfulness training in daily activities Provide homework worksheets. Session 2: Program: Checking homework, teaching the basic assumptions of mindfulness, teaching the basics of meditation theory, introducing the benefits and positive effects of meditation exercises for chronic physical illness, teaching breathing awareness techniques, sitting meditation, pleasant event recording practice, presenting a worksheet Home. Session 3, Program: Checking homework, teaching about thoughts, consciously dealing with negative spontaneous thoughts, teaching, teaching acceptance instead of trying in vain and struggling, teaching how to observe thoughts without judging, technique of observing thoughts (brainstorming), practice Recording unpleasant events, presenting homework worksheets. Session 4, Program: Checking homework, introducing emotion, teaching the difference between feeling with emotion, introducing different types of positive, negative and neutral emotions and learning how to identify them, consciously dealing with negative unpleasant emotions, learning Physical manifestation of emotion in the body using mindfulness and release of physical stress caused by emotion, technique of observing and recognizing emotions, practicing emotion exploration in the body, presenting homework worksheets. Session 5, Program: Checking homework Negi, education about stress and its types, introduction of stress-body cycle, adverse effects of stress on addiction and explaining how to reactivate addiction with stressful event, teaching stress coping strategies, three-minute breathing technique, meditation practice, awareness of body senses and old sounds STOP Practice for Stress Management, Presenting Homework Worksheets. Session 6, Program: Checking Homework, Teaching the Effect of Mindfulness on Managing and Reducing Pain, Explaining the 5-Step Pain Relief Model Using Mindfulness, Exploring and Identifying Unpleasant Body Senses such as Pain In the body and awareness and awareness of them, accepting and coping with pain, practicing physical examination, providing homework worksheets. And the treatment of others, the role of mindfulness in identifying and managing unpleasant moods, emotions, and bodily sensations that make it difficult to engage in behavioral interactions with others, practicing mindfulness in everyday relationships, providing homework worksheets. Letter: Checking homework, overview of the training provided during all previous sessions, how to expand mindfulness in the dimensions of personal life and interpersonal relationships, discussion and exchange of views of group members about changes in their lives during previous sessions and general summary From the entire length of the sessions. Run the post-test. Intervention 2: Intervention group 2: Emotion regulation control training for 8 weeks, one 45-minute session per week based on Gross Theoretical Framework protocol (2002). Session 1, Program: Pre-test, communication and conceptualization, and the need to use emotion regulation training. , Interest and love) and learn to pay attention to positive emotions and the need to use them along with examples in the form of mental visualization, homework to write the major positive emotions and record in the appropriate form. Session 3, Program: Teaching Awareness of Negative Emotions, A Brief Overview of the Previous Session, Teaching Awareness of Negative Emotions and Their Types (Tolerance of Anxiety, Sadness, Anger and Hate) and Teaching Attention to Negative Emotions and the Need to Use Them as Examples Mental Visualization, Homework to Write Major Negative Emotions and Record in the Relevant Form. Emotions, homework, consulting parents and close friends about more or less positive emotions and registering in the relevant form. , Program: Learning to re-evaluate and express positive emotions, reviewing the previous session, teaching the mental experience of positive emotions in the form of mental visualization (happiness, interest and love), mental inhibition and training in the proper expression of these emotions..Seventh Session, Program: Evaluation training Re-expression and negative emotions From inappropriate and inhibition of inappropriate expression of these emotions .. Session 8, Program: Summary of training sessions. Intervention 3: 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 There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tayebeh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Daniel St. Aristotle Complex</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64411 _ 64491</zip>
        <telephone>+98 61 3446 4322</telephone>
        <email>Tayebeh.Jaef@gmail.com</email>
        <affiliation>Navid Zandegi Help Clinic</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tayebeh Jafari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Danyal Street</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>64411 _ 64491</zip>
        <telephone>+98 61 3446 4322</telephone>
        <email>tayebeh.jaef@gmail.com</email>
        <affiliation>Navid Zandegi Help Clinic</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Achieving a score lower than the average in the Distress Tolerance Questionnaire
Get a higher than average score on the Excitement Questionnaire
Having written consent to participate in all treatment sessions</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>16 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having severe physical problems
Having severe mental problems</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>
      <i_code>Behavior</i_code>
      <i_code>Behavior</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Mindfulness-based stress reduction therapy for 8 sessions per week, one 60-minute session per week according to Kabat Zayn (2003). With each other and with the rules of the group, specify the goals and expectations of treatment, explain the nature of addiction and talk to group members about addiction and its effects on their life dimensions, brief introduction of mindfulness, raisin eating practice, body exam, mindfulness training in daily activities Provide homework worksheets. Session 2: Program: Checking homework, teaching the basic assumptions of mindfulness, teaching the basics of meditation theory, introducing the benefits and positive effects of meditation exercises for chronic physical illness, teaching breathing awareness techniques, sitting meditation, pleasant event recording practice, presenting a worksheet Home. Session 3, Program: Checking homework, teaching about thoughts, consciously dealing with negative spontaneous thoughts, teaching, teaching acceptance instead of trying in vain and struggling, teaching how to observe thoughts without judging, technique of observing thoughts (brainstorming), practice Recording unpleasant events, presenting homework worksheets. Session 4, Program: Checking homework, introducing emotion, teaching the difference between feeling with emotion, introducing different types of positive, negative and neutral emotions and learning how to identify them, consciously dealing with negative unpleasant emotions, learning Physical manifestation of emotion in the body using mindfulness and release of physical stress caused by emotion, technique of observing and recognizing emotions, practicing emotion exploration in the body, presenting homework worksheets. Session 5, Program: Checking homework Negi, education about stress and its types, introduction of stress-body cycle, adverse effects of stress on addiction and explaining how to reactivate addiction with stressful event, teaching stress coping strategies, three-minute breathing technique, meditation practice, awareness of body senses and old sounds STOP Practice for Stress Management, Presenting Homework Worksheets. Session 6, Program: Checking Homework, Teaching the Effect of Mindfulness on Managing and Reducing Pain, Explaining the 5-Step Pain Relief Model Using Mindfulness, Exploring and Identifying Unpleasant Body Senses such as Pain In the body and awareness and awareness of them, accepting and coping with pain, practicing physical examination, providing homework worksheets. And the treatment of others, the role of mindfulness in identifying and managing unpleasant moods, emotions, and bodily sensations that make it difficult to engage in behavioral interactions with others, practicing mindfulness in everyday relationships, providing homework worksheets. Letter: Checking homework, overview of the training provided during all previous sessions, how to expand mindfulness in the dimensions of personal life and interpersonal relationships, discussion and exchange of views of group members about changes in their lives during previous sessions and general summary From the entire length of the sessions. Run the post-test.</i_keyword>
      <i_keyword>Intervention group 2: Emotion regulation control training for 8 weeks, one 45-minute session per week based on Gross Theoretical Framework protocol (2002). Session 1, Program: Pre-test, communication and conceptualization, and the need to use emotion regulation training. , Interest and love) and learn to pay attention to positive emotions and the need to use them along with examples in the form of mental visualization, homework to write the major positive emotions and record in the appropriate form. Session 3, Program: Teaching Awareness of Negative Emotions, A Brief Overview of the Previous Session, Teaching Awareness of Negative Emotions and Their Types (Tolerance of Anxiety, Sadness, Anger and Hate) and Teaching Attention to Negative Emotions and the Need to Use Them as Examples Mental Visualization, Homework to Write Major Negative Emotions and Record in the Relevant Form. Emotions, homework, consulting parents and close friends about more or less positive emotions and registering in the relevant form. , Program: Learning to re-evaluate and express positive emotions, reviewing the previous session, teaching the mental experience of positive emotions in the form of mental visualization (happiness, interest and love), mental inhibition and training in the proper expression of these emotions..Seventh Session, Program: Evaluation training Re-expression and negative emotions From inappropriate and inhibition of inappropriate expression of these emotions .. Session 8, Program: Summary of training sessions.</i_keyword>
      <i_keyword>Control group: Does not receive any intervention</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Anxiety tolerance. Timepoint: Before and after the intervention. Method of measurement: Simmons and Gahr  Distress Tolerance Questionnaire.</prim_outcome>
      <prim_outcome>Excitement. Timepoint: Before and after the intervention. Method of measurement: Zuckerman Excitement Questionnaire.</prim_outcome>
      <prim_outcome>Addiction Potential. Timepoint: Before and after the intervention. Method of measurement: Wade and et al 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>Navid Zandegi Help Clinic</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-07-18</approval_date>
        <contact_name>Ethics Committee of Islamic Azad University, Ahvaz Branch</contact_name>
        <contact_address>Golestan Highway ahvaz Khouzestan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
