<?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>IRCT20231125060172N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-16</date_registration>
      <primary_sponsor>Vice-Chancellor of Research at Azad Neyshabur University</primary_sponsor>
      <public_title>The effectiveness of problem-solving cognitive behavioral therapy on aggression</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of cognitive behavioral therapy focused on problem solving on rumination, alexithymia and loneliness in students with aggressive behaviors</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/73966</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Other design features: In the current study, there are two experimental and control groups. The intervention consists of eight one-hour sessions, cognitive behavioral therapy focused on problem solving, derived from the treatment protocol of Nezu and Desorilla, which is performed on the experimental group. The control group does not receive any intervention. The scores of rumination, emotional dyslexia, and loneliness questionnaires of both groups are measured and compared before and after the intervention. The follow-up period is done after two months, Randomization description: The statistical population is all the students of the first secondary schools of Neyshabur. Two schools are selected as sampling units using the accessible method. After implementing Bass and Perry's aggression questionnaire 30 students who scored higher than 75 are identified. Each student is assigned a number. Put the numbers in a container Put the numbers in a container and 15 students  are selected by lottery for each of the control and experimental groups, Blinding description: The participants of both groups do not know about the study and the experiment in which they are in, so they are kept blind.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Aggressive behaviors.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This group received eight one-hour sessions of problem solving skills based on the protocol of Nezu and DesorillSession 1: Familiarization and introduction of the members, review of goals and expectations, rules, explanation about the length and duration of the meetings,                                                                                                           2- Familiarization and training with the ABCD model. A events that happened. B is the opinion about that incident. C emotional consequences of this way of thinking, D discussion and challenge; recognize their negative spontaneous thoughts, get involved with these thoughts and try to gradually replace them with positive or logical thoughts. Specifying homework and thought recording sheets                                                       3- Teaching problem solving steps including: explaining the treatment and its logic, diagnosis, definition and analysis of the problem, determining achievable goals, creating solutions, evaluating and choosing a solution, performing the selected solution, evaluation The result after the completion of the solution, determining the assignment, applying the problem solving method in life situations and recording it.                          4- Introducing the use of joking in anger-inducing situations, explaining the concept of one's attitude to life with the use of humor along with maintaining the perspective-taking method. Setting the homework of using two sides of jokes (combating with enjoyable activities and using jokes to avoid anger) during the next week                                                     5- Reviewing the concept of self-talk and emphasizing the difference between anger-increasing and anger-reducing self-talks, helping to identify more anger-increasing and anger-reducing self-talks, strengthening the ability to understand the concept of perspective-taking and the behavior of playing the intellectual game of self-talk in the meeting and also practicing it outside the meeting.                                                                    6- Teaching the successive stages of problem solving, including identifying the problem, thinking about the action, thinking about the consequences of the action (sequential thinking), generating a solution (substitution thinking), understanding step by step to achieve special goals (semantic thinking) and looking at the problem from the perspective of others (viewpointing) ) through the game of choice.                                7- Training to differentiate between aggressive, passive, passive aggressive, and assertive responses. Determining the individual rights of people in different situations, identifying and confronting irrational thoughts that support non-assertive behaviors. Practicing assertive responses in various anger-stimulating situations through power play        8 -Reviewing and summarizing skills taught in past sessions to help participants apply them in future situations. Intervention 2: Control group: 15 students who had an aggression score higher than 75 were randomly placed in this group. This group answered three questionnaires before the beginning and after the end of the training sessions of the experimental group: Nalen and Hoeksma rumination, TAS 20 Toronto and UCLA. The control group did not receive any training or treatment.</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 data is potentially shareable after de-identifying individuals

When:
The access period starts 6 months after the results are published

To whom:
Researchers working in academic and scientific institutions

Conditions:
Students with aggressive behaviors, schools, education, counseling centers and psychological clinics can benefit from the results of this research.

Where to obtain:
zsoghandi802@gmail.com

How to obtain:
Three months after submitting the application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Zeanab Soghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19، 6/3 Amir kabir Ave.</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9314737459</zip>
        <telephone>+98 51 4334 0929</telephone>
        <email>zsoghandi812@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Zeanab Soghandi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No 19، 6/3 Amir kabir Ave.</address>
        <city>Neyshabour</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9314737459</zip>
        <telephone>+98 51 4334 0929</telephone>
        <email>zsoghandi812@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Failure to participate in other counseling and psychotherapy sessions at the same time
Consent to participate in Training sessions
Obtaining a score higher than 75 in Bass and Perry aggression questionnaire
Students studying in the first secondary section  in 2024-2025</inclusion_criteria>
      <agemin>13 years</agemin>
      <agemax>15 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having an incurable physical disease such as cancer, seizure attacks, heart disease
Attending counseling or psychotherapy sessions in the previous six months
Obtaining a low score in the aggression questionnaire</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>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This group received eight one-hour sessions of problem solving skills based on the protocol of Nezu and DesorillSession 1: Familiarization and introduction of the members, review of goals and expectations, rules, explanation about the length and duration of the meetings,                                                                                                           2- Familiarization and training with the ABCD model. A events that happened. B is the opinion about that incident. C emotional consequences of this way of thinking, D discussion and challenge; recognize their negative spontaneous thoughts, get involved with these thoughts and try to gradually replace them with positive or logical thoughts. Specifying homework and thought recording sheets                                                       3- Teaching problem solving steps including: explaining the treatment and its logic, diagnosis, definition and analysis of the problem, determining achievable goals, creating solutions, evaluating and choosing a solution, performing the selected solution, evaluation The result after the completion of the solution, determining the assignment, applying the problem solving method in life situations and recording it.                          4- Introducing the use of joking in anger-inducing situations, explaining the concept of one's attitude to life with the use of humor along with maintaining the perspective-taking method. Setting the homework of using two sides of jokes (combating with enjoyable activities and using jokes to avoid anger) during the next week                                                     5- Reviewing the concept of self-talk and emphasizing the difference between anger-increasing and anger-reducing self-talks, helping to identify more anger-increasing and anger-reducing self-talks, strengthening the ability to understand the concept of perspective-taking and the behavior of playing the intellectual game of self-talk in the meeting and also practicing it outside the meeting.                                                                    6- Teaching the successive stages of problem solving, including identifying the problem, thinking about the action, thinking about the consequences of the action (sequential thinking), generating a solution (substitution thinking), understanding step by step to achieve special goals (semantic thinking) and looking at the problem from the perspective of others (viewpointing) ) through the game of choice.                                7- Training to differentiate between aggressive, passive, passive aggressive, and assertive responses. Determining the individual rights of people in different situations, identifying and confronting irrational thoughts that support non-assertive behaviors. Practicing assertive responses in various anger-stimulating situations through power play        8 -Reviewing and summarizing skills taught in past sessions to help participants apply them in future situations.</i_keyword>
      <i_keyword>Control group: 15 students who had an aggression score higher than 75 were randomly placed in this group. This group answered three questionnaires before the beginning and after the end of the training sessions of the experimental group: Nalen and Hoeksma rumination, TAS 20 Toronto and UCLA. The control group did not receive any training or treatment.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aggressive behavior scores of students in Bass and Perry aggression questionnaire. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Bass and Perry Aggression 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>Vice-Chancellor of Research at Azad Neyshabur University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-02-14</approval_date>
        <contact_name>Ethics committee of Neyshabur Islamic Azad University</contact_name>
        <contact_address>Neyshabur Islamic Azad University, Paghouhesh  Blvd Neyshabur Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
