<?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>IRCT20240906062958N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-11</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The Effectiveness of Group Acceptance and Commitment Therapy On  Internet Addition</public_title>
      <acronym>ACT</acronym>
      <scientific_title>The Effectiveness of Group Acceptance and Commitment Therapy on Anxiety, Internet Aggression and Social Isolation in Adolescent with Internet Addition</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-09-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78873</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Factorial, Purpose: Prevention, Randomization description: In order to conduct the research, the researcher refers to Kashan schools (girls and boys) with a written introduction letter from Kashan University of Medical Sciences. Adolescents who complete the internet addiction questionnaire and have internet addiction and meet the entry criteria are randomly selected in a stratified manner. In the first visit of the researcher, in order to comply with the ethical principles, information about the research was given to the participants (the number of meetings, the duration of each meeting, the way the meeting was held, etc.) and the right to withdraw from the research is provided. At any time, their consent will be obtained to participate in the research. Then, people who meet the inclusion criteria are randomly assigned to two treatment groups based on acceptance and commitment (ACT) and the control group. In the pre-test phase, all participants will complete questionnaires on Internet addiction, technology anxiety, Internet aggression, and social isolation. In order to eliminate the effect of the order of the questionnaires and to control the effect of the subjects' fatigue in answering the questions, a balance is made, so that the order of the questionnaires is changed randomly in all participants. It is also possible for them to answer questions twice.
After completing the research tools in the pre-test stage, the ACT group patients will participate in 8 45-minute group therapy sessions weekly based on the treatment protocol, while the control group participants will not receive any treatment during this period. . , but in order to comply with ethical considerations, they will only receive psychological training unrelated to treatment (such as critical thinking training). After the treatment sessions are over, the above questionnaires will be administered again. Also, to check the durability of the effects of the treatment intervention, the participants of both groups, two months after the completion of the treatment and in the follow-up phase, will answer all the research tools again, and finally, the collected data will be analyzed and is analyzed.
Also, in order to comply with professional ethics, after the completion of the follow-up phase, the participants in the control group will also undergo ACT treatment. It should be noted that the therapist is trained in the field of therapy based on acceptance and commitment. In addition, treatment sessions will be held under the supervision and advice of supervisors and consultants specializing in this treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Internet Addiction.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: includes control group and intervention group. The intervention group will receive treatment based on acceptance and commitment in 8 sessions of 45 minutes, and the control group will not receive treatment during this time. But in order to comply with ethical considerations after the end of the treatment, acceptance and commitment therapy or a type of psychological training will also be implemented for the control group if the members of the control group wish..</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is No decision has been made yet. A final decision will be made after the research officials consult with each other.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr.Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom</address>
        <city>Ghoum</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3711353139</zip>
        <telephone>+98 25 3231 3242</telephone>
        <email>reyhansadatghazanfary@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr.Hamid Amiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Hasht Behesht Complex, 1 Mutalefe Alley, Pardisan, Qom</address>
        <city>Ghoum</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3711353139</zip>
        <telephone>+98 25 3231 3242</telephone>
        <email>reyhansadatghazanfary@gmail.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>To receive a score of more than 46 in the internet addiction questionnaire
Minimum age is 12 and maximum age is 17
Having the physical ability to perform the exercises that are determined in each session
Absence of mental disorders requiring immediate treatment, such as drug and alcohol abuse disorders, psychotic disorders, depression disorders
Non-receipt Psychological interventions during the last year and related drug treatment at least one month before the baseline measurement phase</inclusion_criteria>
      <agemin>12 years</agemin>
      <agemax>17 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>No response to more than 5% of research questions
Lack of motivation and satisfaction to participate in the research
The occurrence of unfortunate events such as the loss of loved ones for a person
The person's unwillingness to continue the treatment
Absence for two sessions in treatment
Occurrence of stress caused by exams or any other issue causing tension and stress
Having to mental disorder that requires immediate treatment, such as drug and alcohol use disorder, psychotic disorders, and depression
Thinking about harming or killing yourself
Lack of physical ability to perform the exercises that are determined in each session (for example: having a lot of pain)
Simultaneous participation in another treatment program</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>Prevention</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: includes control group and intervention group. The intervention group will receive treatment based on acceptance and commitment in 8 sessions of 45 minutes, and the control group will not receive treatment during this time. But in order to comply with ethical considerations after the end of the treatment, acceptance and commitment therapy or a type of psychological training will also be implemented for the control group if the members of the control group wish.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Internet addiction score in Young's Internet Addiction Questionnaire. Timepoint: Measuring internet addiction, anxiety, internet aggression and social isolation at the beginning of the study (before the start of the intervention) and 2 months later (in the follow-up phase). Method of measurement: Kimberly Young Internet Addiction Questionnaire - Beck Anxiety Questionnaire - Alvarez, Garcia et al. Cyber ​​Aggression Questionnaire - Russell et al. Loneliness Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Anxiety score in Beck Anxiety Questionnaire. Timepoint: Anxiety score at the beginning of the study (before the intervention) and 2 months later (in the follow-up phase). Method of measurement: Beck's 21-question anxiety questionnaire.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-07-14</approval_date>
        <contact_name>Ethics Committee of Kashan University of Medical Sciences</contact_name>
        <contact_address>Unit 15, Block 8, Hasht Behesht Building, Mutalefe 1 Alley, Abu Talib street., Pardisan, Qom Ghoum Ghoum Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
