<?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>IRCT20250117064414N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2025-02-12</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Dialectical Behavior Therapy for Posttraumatic Stress Disorder (DBT-PTSD) for Treatment Outcome of Non-Suicidal Self-Injury Disorder</public_title>
      <acronym>DBT-PTSD &amp; NSSI</acronym>
      <scientific_title>Effectiveness of Dialectical Behavior Therapy for Posttraumatic Stress Disorder (DBT-PTSD) for Treatment Outcome of Non-Suicidal Self-Injury Disorder in People with a history of Childhood Abuse and Determining the Mechanisms of Change</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2025-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/81536</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 30 people with Non-Suicidal Self-Injury Disorder will be categorized into 2 groups (control, experiment) randomly. the names of all subjects will be written separately on piece of papers.Then they are thrown into a box and members of both control and experiment groups are selected randomly . The control and experiment groups each included 15 members.</study_design>
      <phase>N/A</phase>
      <hc_freetext>.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group:  12 weeks of dialectical behavior therapy for post-traumatic stress disorder will be performed in the form of group (90 minutes) and individual (45 minutes) weekly sessions that include dialectical behavior therapy techniques. The treatment steps include: 1- Behavioral analysis, specific dialectical behavior therapy skills for behavior control (identifying the individual's strategies for escaping from initial trauma-related emotions (such as dissociation/dissociation, non-suicidal self-harm) and controlling behavior), 2- Cognitive and exposure-based interventions focused on the trauma, coping skills (balancing memory activation and awareness of being present in the present and reducing dissociative/dissociative features), and 3- Fundamental acceptance of the facts related to the trauma (returning to normal daily life). Intervention 2: Control group: trauma focused - cognitive behavioral therapy (one 45-minute session per week for each individual)will be performed for the control group over 12 weeks. The treatment phases include: 1- consolidation and skill building, parent guidance and feedback to parents, coping skills training (focusing on therapeutic participation and psychoeducation about the prevalence, impact, and treatment of the trauma/incident, strengthening parental support for the patient, employing coping skills), 2- narrative (retelling) and processing of the trauma/incident, focusing directly on the details of traumatic memories, challenging maladaptive beliefs, meaning, and consequences of the trauma/incident (processing difficult feelings and supporting these feelings, sharing the patient's narrative of the trauma/incident with the parents to gain support), and 3- integration and consolidation, joint parent-patient meetings, sharing the narrative, and teaching safety skills (preventing revictimization).</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:
The outcome and conclusion of the data will be published in article after the end of the interventions. All questionnaires and scales that are used, are available.

When:
The beginning of availability period will be winter of 1404

To whom:
Will be available for everyone.

Conditions:
no analysis on data is allowed. Only the protocol can be used and referenced.

Where to obtain:
Younes Zaheri\ zzaheriyones@gmail.com

How to obtain:
After requesting an email, it will be sent within a maximum of two weeks.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Younes Zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Behavioral Sciences and Mental Health, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 8670 3075</telephone>
        <email>zzaheriyones@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Younes Zaheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Behavioral Sciences and Mental Health, Iran University of Medical Sciences (IUMS), Shahid Hemmat Highway, Tehran 14</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613111</zip>
        <telephone>+98 21 8670 3075</telephone>
        <email>zzaheriyones@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of non-suicidal self-harm disorder based on the Structured Clinical Interview for DSM-5 (SCID-I) as the primary diagnosis and comorbidity
Experience of childhood maltreatment (must be one of the maltreatment cases, physical or sexual abuse).
Age range between 16 and 24 years
Education at least sixth grade of primary school</inclusion_criteria>
      <agemin>16 years</agemin>
      <agemax>24 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Receiving other psychological treatments in the past six months
Presence of psychotic symptoms based on SCID
Presence of organic diseases and severe physical diseases such as multiple sclerosis (MS) based on the patient's record
Substance use disorder and bipolar disorder type 1 and 2
Serious difficulty in understanding questionnaire items
Severe personality disorders</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>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group:  12 weeks of dialectical behavior therapy for post-traumatic stress disorder will be performed in the form of group (90 minutes) and individual (45 minutes) weekly sessions that include dialectical behavior therapy techniques. The treatment steps include: 1- Behavioral analysis, specific dialectical behavior therapy skills for behavior control (identifying the individual's strategies for escaping from initial trauma-related emotions (such as dissociation/dissociation, non-suicidal self-harm) and controlling behavior), 2- Cognitive and exposure-based interventions focused on the trauma, coping skills (balancing memory activation and awareness of being present in the present and reducing dissociative/dissociative features), and 3- Fundamental acceptance of the facts related to the trauma (returning to normal daily life).</i_keyword>
      <i_keyword>Control group: trauma focused - cognitive behavioral therapy (one 45-minute session per week for each individual)will be performed for the control group over 12 weeks. The treatment phases include: 1- consolidation and skill building, parent guidance and feedback to parents, coping skills training (focusing on therapeutic participation and psychoeducation about the prevalence, impact, and treatment of the trauma/incident, strengthening parental support for the patient, employing coping skills), 2- narrative (retelling) and processing of the trauma/incident, focusing directly on the details of traumatic memories, challenging maladaptive beliefs, meaning, and consequences of the trauma/incident (processing difficult feelings and supporting these feelings, sharing the patient's narrative of the trauma/incident with the parents to gain support), and 3- integration and consolidation, joint parent-patient meetings, sharing the narrative, and teaching safety skills (preventing revictimization).</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Non-Suicidal Self-Injury symptoms. Timepoint: Non-Suicidal Self-Injury symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: Sanson et al. Self-harm Questionnaire.</prim_outcome>
      <prim_outcome>Negative cognition symptoms. Timepoint: Negative cognition symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: Posttraumatic Cognitions Inventory.</prim_outcome>
      <prim_outcome>Perceived Invalidation of Emotion  symptoms. Timepoint: Perceived Invalidation of Emotion symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: The Perceived Invalidation of Emotion Scale.</prim_outcome>
      <prim_outcome>Depression symptoms. Timepoint: Depression symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: Beck Depression Inventory-II.</prim_outcome>
      <prim_outcome>Emotion regulation symptoms. Timepoint: Emotion regulation symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: Emotion Regulation Questionnaire-8.</prim_outcome>
      <prim_outcome>Generalized anxiety symptoms. Timepoint: Generalized anxiety symptoms are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, three months after the last session of the treatment course. Method of measurement: Generalized Anxiety Disorder Questionnaire-7.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The Work and Social Adjustment Scores. Timepoint: The Work and Social Adjustment Scores are measured before the first session of treatment, and after the end of treatment course. variables will be measured for the last time, a month after the last session of the treatment course. Method of measurement: The Work and Social Adjustment Scale.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-04-27</approval_date>
        <contact_name>Research Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences (IUMS),Next to Milad Tower, Shahid Hemmat Highway, Tehran, IRAN Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
