<?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>IRCT20220705055377N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-13</date_registration>
      <primary_sponsor>Semnan Islamic Azad University</primary_sponsor>
      <public_title>Comparison of the effect of Cognitive-behavioral therapy and Emotion-focused therapy on reducing self-injury function in adolescents</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of Cognitive-behavioral therapy and Emotion-focused therapy on reducing self-injury function in adolescents</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-07-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>45</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64649</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomness is done by lottery method. In this method, a code or number is prepared for each member of the sample, then the numbers are written on pieces of paper. The pieces of paper are placed in a container and mixed well, then 15 people are selected for the first treatment, 15 people for the second treatment and 15 people for the control group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Non-suicidal self-injury.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group1: Intervention group 1: The program of cognitive behavioral therapy of self-injury is presented based on a flexible system and model. The treatment techniques of this treatment are effective on teenagers and young people who self-injure. This treatment has 13 sessions of 45 minutes and 51 pages of worksheets are considered for assignments (Tyler et al., 2015). First session :Educating teenagers about what self-injury is (first component: What is self-injury?) and providing the necessary information regarding the functions of self-injury and the timeline of self-injury behaviors (second component: the function of self-injury)second session:Identifying specific treatment problems and goals (third component: problems and goals). Introducing cognitive behavioral therapy and explaining how this therapy can be useful for self-harm (fourth component: What is cognitive behavioral therapy and how can it help my self-harm). Empowering teenagers to identify and understand their feelings (the fifth component: recognizing feelings).third session:Adolescents come to understand how self-harm has dominated their lives (sixth component: relationships and strengths). We prepare the teenager to be motivated to change (seventh component: Are you ready to change?) .Second stage: treatment planThe second stage of treatment has two main parts. In the first part, the thoughts, feelings and behaviors of the patient are discussed, and in the second part, the focus of the treatment is on solutions.fourth Session:This meeting has two parts. First, a review of the emotional memories of the fifth component is done, then if the teenager is in a depressed mood, activity planning is done. If activity planning is not necessary because the teenager has engaged in healthy activities during the week or the lack of activity is not the cause of depression, then the ninth component, the help triangle, can be used.By examining the emotional memories, we deal with the adolescent's feelings and examine the intensity and frequency of the feeling and discuss it (Eighth Component). We identify and examine the relationship between lack of feeling of success and lack of activity, contempt and lack of pleasure. We want fun activities to be done by examining the lost feelings during the week (continuation of component 8).fifth meeting:Introducing the help triangle (ninth component). Introduction and identification of negative spontaneous thoughts like help (tenth component).The sixth session:To identify negative spontaneous thoughts, two-dimensional thinking (black and white) and cognitive petrification, we use challenging thoughts and finding evidence for and against thoughts (11th component).The seventh session:Identification of fundamental beliefs (the twelfth component).The eighth session:Through cognitive-behavioral formula, we make teenagers understand their behavioral patterns. We use the collection of past and present experiences, fundamental beliefs and current maintaining factors for this purpose (the 13th component).The ninth session:A decision is made about what coping strategy is suitable for the teenager (fourteenth component). Introducing the concept of problem solving (15th component).Tenth session:Three techniques that help to manage tension and positive interaction are discussed (components 16, 17, and 18: self-expression training, anger management, and self-care).The eleventh session:Training to deal with fear and situation (19th component).The second meeting:Teaching emotions control (riding waves), self-awareness and self-acceptance and self-soothing to teenagers (components 20, 21 and 22).Thirteenth session:Considering coping alternatives for self-harm and summarizing the coping strategies that have been discussed during the previous sessions (component 23). Intervention 2: Intervention group2: Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). The first session: introducing and presenting the concepts of emotion-oriented therapy. Making the clients aware of their emotions according to the physical sensations and the conceptualization of the case done by the therapist. The second session: the client welcomes and accepts his emotional experience. If necessary, emotion regulation is done by the therapist. The third session: description of feelings in the form of words by the client and presentation of emotional notebook assignment. The fourth session: discovery of primary and secondary emotions by the client with the help of the therapist. The second stage of treatment: quitting. They can trust the feeling they have reached as a good source of information or not, whether this feeling is useful or not, finally whether it is necessary to change this feeling or not (Greenberg, 2015). Fifth session: Evaluation Regarding whether the primary emotion is a healthy or unhealthy response. The sixth session: Helping the client to identify the negative voice associated with unhealthy emotion. Access to alternative healthy emotional responses Session 9: Creating a new narrative to challenge destructive beliefs and opinions about self becoming. Intervention 3: Control group: Control group: A group of 15 people will be considered as a control 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>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 There is no information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>kiana kheirkhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan, Iran</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۰۲۳۳۳۶۵۴۰۳۶</zip>
        <telephone>۰۲۳-۳۳۶۵۴۰۴۰-۹</telephone>
        <email>k.kheirkhah74@gmail.com</email>
        <affiliation>Semnan Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>kiana kheikhah</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Islamic Azad University, University Town, Semnan, Iran</address>
        <city>semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۳۵۱۳۱۳۷۱۱۱</zip>
        <telephone>۰۲۳-۳۳۶۵۴۰۴۰-۹</telephone>
        <email>k.kheirkhah74@gmail.com</email>
        <affiliation>Semnan Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adolescents between the ages of 14 and 18 who have harmed their body in 5 days or more in the last year.
Injuring the body without suicidal intent.
This behavior has resulted in clinically significant distress in interpersonal and academic functioning and other important areas.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>18 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Not having any other mental illness other than non-suicidal self-harm.
Not taking medicine during the research period
No drug addiction
Absence of acute and chronic diseases or events such as parental divorce in the previous year
No death of loved ones in the last 6 months</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group1: Intervention group 1: The program of cognitive behavioral therapy of self-injury is presented based on a flexible system and model. The treatment techniques of this treatment are effective on teenagers and young people who self-injure. This treatment has 13 sessions of 45 minutes and 51 pages of worksheets are considered for assignments (Tyler et al., 2015). First session :Educating teenagers about what self-injury is (first component: What is self-injury?) and providing the necessary information regarding the functions of self-injury and the timeline of self-injury behaviors (second component: the function of self-injury)second session:Identifying specific treatment problems and goals (third component: problems and goals). Introducing cognitive behavioral therapy and explaining how this therapy can be useful for self-harm (fourth component: What is cognitive behavioral therapy and how can it help my self-harm). Empowering teenagers to identify and understand their feelings (the fifth component: recognizing feelings).third session:Adolescents come to understand how self-harm has dominated their lives (sixth component: relationships and strengths). We prepare the teenager to be motivated to change (seventh component: Are you ready to change?) .Second stage: treatment planThe second stage of treatment has two main parts. In the first part, the thoughts, feelings and behaviors of the patient are discussed, and in the second part, the focus of the treatment is on solutions.fourth Session:This meeting has two parts. First, a review of the emotional memories of the fifth component is done, then if the teenager is in a depressed mood, activity planning is done. If activity planning is not necessary because the teenager has engaged in healthy activities during the week or the lack of activity is not the cause of depression, then the ninth component, the help triangle, can be used.By examining the emotional memories, we deal with the adolescent's feelings and examine the intensity and frequency of the feeling and discuss it (Eighth Component). We identify and examine the relationship between lack of feeling of success and lack of activity, contempt and lack of pleasure. We want fun activities to be done by examining the lost feelings during the week (continuation of component 8).fifth meeting:Introducing the help triangle (ninth component). Introduction and identification of negative spontaneous thoughts like help (tenth component).The sixth session:To identify negative spontaneous thoughts, two-dimensional thinking (black and white) and cognitive petrification, we use challenging thoughts and finding evidence for and against thoughts (11th component).The seventh session:Identification of fundamental beliefs (the twelfth component).The eighth session:Through cognitive-behavioral formula, we make teenagers understand their behavioral patterns. We use the collection of past and present experiences, fundamental beliefs and current maintaining factors for this purpose (the 13th component).The ninth session:A decision is made about what coping strategy is suitable for the teenager (fourteenth component). Introducing the concept of problem solving (15th component).Tenth session:Three techniques that help to manage tension and positive interaction are discussed (components 16, 17, and 18: self-expression training, anger management, and self-care).The eleventh session:Training to deal with fear and situation (19th component).The second meeting:Teaching emotions control (riding waves), self-awareness and self-acceptance and self-soothing to teenagers (components 20, 21 and 22).Thirteenth session:Considering coping alternatives for self-harm and summarizing the coping strategies that have been discussed during the previous sessions (component 23).</i_keyword>
      <i_keyword>Intervention group2: Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). Intervention group 2: In this research, emotion-oriented therapy means the number of nine intervention sessions (Greenberg, 2015). The first session: introducing and presenting the concepts of emotion-oriented therapy. Making the clients aware of their emotions according to the physical sensations and the conceptualization of the case done by the therapist. The second session: the client welcomes and accepts his emotional experience. If necessary, emotion regulation is done by the therapist. The third session: description of feelings in the form of words by the client and presentation of emotional notebook assignment. The fourth session: discovery of primary and secondary emotions by the client with the help of the therapist. The second stage of treatment: quitting. They can trust the feeling they have reached as a good source of information or not, whether this feeling is useful or not, finally whether it is necessary to change this feeling or not (Greenberg, 2015). Fifth session: Evaluation Regarding whether the primary emotion is a healthy or unhealthy response. The sixth session: Helping the client to identify the negative voice associated with unhealthy emotion. Access to alternative healthy emotional responses Session 9: Creating a new narrative to challenge destructive beliefs and opinions about self becoming</i_keyword>
      <i_keyword>Control group: Control group: A group of 15 people will be considered as a control group</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The percentage of people who have self-harmed at least 5 times in the past year. Timepoint: Measuring self-injury at the beginning of the study and after receiving interventions at the end of the study. Method of measurement: Self-injury questionnaire of Sanson (SHI).</prim_outcome>
      <prim_outcome>The percentage of people who have self-harm functions. Timepoint: Measuring self-injury at the beginning of the study and after receiving interventions at the end of the study. Method of measurement: Klonsky and Glenn self-injury functions questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>-. Timepoint: -. Method of measurement: -.</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>Semnan Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-24</approval_date>
        <contact_name>Ethics Committee of Semnan Azad University</contact_name>
        <contact_address>Islamic Azad University, University Town, Semnan, Iran semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
