<?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>IRCT20241116063743N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-12-23</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of acceptance and commitment therapy on shyness</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of Compassion-Enriched Acceptance and Commitment Therapy, Alexithymia , anxiety and social adjustment of shy adolescent girls</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>36</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/80205</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Alexithymia,social adjustment,shy adolescent girls،emotional deficiency.</hc_freetext>
      <i_freetext>Intervention 1: In this study, acceptance and commitment therapy enriched with compassion is an intervention designed based on the Hayes and Gilbert guidelines. The treatment will be implemented in 8 90-minute sessions, 1 session per week. The goals and content of the sessions are as follows:1.Introducing therapy sessions and conducting a pre-test, introducing and getting to know the group members, stating the group rules and goals, introducing ACT therapy focused on compassion, suffering, healing, and introducing the causes of human suffering.2.Efficiency as a measurement criterion, creating creative despair, introducing emotion regulation systems, introducing types of human suffering, introducing types of human needs, introducing dimensions of compassion 3.Expressing control as a problem, the conscious brain 4.Using cognitive decoupling techniques, interfering with the functioning of problematic language chains, weakening self-alignment with thoughts and emotions 5.Weakening the self-concept and expressing oneself as an observer, demonstrating the separation between self, inner experiences and behavior, applying mindfulness techniques, performing imagery, introducing the characteristics of a kind person. 6.Modeling going out of mind, learning to see inner experiences as a process, introducing different dimensions of compassionate attention, introducing non-judgmentalism 7.Showing the dangers of focusing on results, discovering practical values ​​in life, retelling the characteristics of a kind person, introducing kind behavior, introducing types of compassionate behavior. 8.Determining patterns of action consistent with values, reintroducing kind behavior, conducting a post-test. Intervention 2: Control group: No activity was done on the control group, and after the intervention on the experimental group, the two groups were compared again.</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:
All of the data can be shared All data is shareable except information with which individuals can be identified

When:
Access starts 6 months after the results are published

To whom:
Researchers and students in the field of mental health

Conditions:
No special conditions are required

Where to obtain:
For researchers and students in the field of mental health
Please refer to the email address lavasanimahla72@gmail.com

How to obtain:
The data will be provided to the applicant after receiving the email and necessary review

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>seyedeh mahla lavasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shahband street , nezam mohandesi street , in front of koosha sang 5 , sargol apartment</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816789845</zip>
        <telephone>+98 11 3360 8778</telephone>
        <email>lavasanimahla72@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>seyedeh mahla lavasani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>shahband street , nezam mohandesi street , in front of kousha sang 5 , sargol apartment</address>
        <city>sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4816789845</zip>
        <telephone>+98 11 3360 8778</telephone>
        <email>lavasanimahla72@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Having a high score in the shyness questionnaire (a score higher than 28 in the shyness questionnaire)
Not receiving clinical or pharmaceutical counseling services at the same time as the research
Not having a disease or psychological disorder outside of the variables discussed in the research</inclusion_criteria>
      <agemin>15 years</agemin>
      <agemax>18 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Unwillingness to continue participating in research
Absence more than 2 times in treatment sessions
Having a disease or psychological disorders interfering in the results, during the implementation of the research
receiving drug treatment or clinical interventions at the time of conducting the research</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F06.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Anxiety disorder due to known physiological condition</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In this study, acceptance and commitment therapy enriched with compassion is an intervention designed based on the Hayes and Gilbert guidelines. The treatment will be implemented in 8 90-minute sessions, 1 session per week. The goals and content of the sessions are as follows:1.Introducing therapy sessions and conducting a pre-test, introducing and getting to know the group members, stating the group rules and goals, introducing ACT therapy focused on compassion, suffering, healing, and introducing the causes of human suffering.2.Efficiency as a measurement criterion, creating creative despair, introducing emotion regulation systems, introducing types of human suffering, introducing types of human needs, introducing dimensions of compassion 3.Expressing control as a problem, the conscious brain 4.Using cognitive decoupling techniques, interfering with the functioning of problematic language chains, weakening self-alignment with thoughts and emotions 5.Weakening the self-concept and expressing oneself as an observer, demonstrating the separation between self, inner experiences and behavior, applying mindfulness techniques, performing imagery, introducing the characteristics of a kind person. 6.Modeling going out of mind, learning to see inner experiences as a process, introducing different dimensions of compassionate attention, introducing non-judgmentalism 7.Showing the dangers of focusing on results, discovering practical values ​​in life, retelling the characteristics of a kind person, introducing kind behavior, introducing types of compassionate behavior. 8.Determining patterns of action consistent with values, reintroducing kind behavior, conducting a post-test</i_keyword>
      <i_keyword>Control group: No activity was done on the control group, and after the intervention on the experimental group, the two groups were compared again.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Alexithymia. Timepoint: The effect of therapy based on acceptance and commitment, enriched with compassion, on emotional distress. Measurement of emotional distress is performed before the intervention and after its completion. Method of measurement: Toronto Emotional Dysfunction Questionnaire.</prim_outcome>
      <prim_outcome>Social anxiety. Timepoint: The effect of therapy based on acceptance and commitment enriched with compassion on social anxiety, measurement of social anxietyis done before the start of the intervention and after its completion. Method of measurement: Social Anxiety Questionnaire (SPIN).</prim_outcome>
      <prim_outcome>Increase social adjustment. Timepoint: The effect of therapy based on acceptance and commitment enriched with compassion on social adjustment. Measurement of social adjustment is done before the start of the intervention and after its completion. Method of measurement: California Social Adjustment Questionnaire Thorpe et al.</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>No</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-11-17</approval_date>
        <contact_name>Ethics committee of azad University of sari branch</contact_name>
        <contact_address>Shahband Street,  nezam mohandesi Street, in front of kushasang 5 Sari Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
