<?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>IRCT20210421051033N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-08-09</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>efficacy of psychotherapy in personality disorder</public_title>
      <acronym></acronym>
      <scientific_title>efficacy Of Integration Of  Biofeedback And Stand-Alone DBT Skills In Borderline Personality Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>4</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56821</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, people referred by a psychiatrist, and diagnosed with borderline personality disorder, are interviewed by the therapist and clinic staff. If the conditions of the fifth handbook of mental disorders based on personality disorder and the conditions for entering treatment are met, these people are randomly divided into two groups of intervention and control by random allocation software, each of group has a capacity of 2 people.
The intervention group and the control group enter psychotherapy in two different centers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>borderline personality disorder.</hc_freetext>
      <i_freetext>Intervention 1: Control group: Behavior therapy techniques 12 sessions. The first 6 sessions of mindfulness techniques based on the latest handbook of Dr. Marsha Linhan and the second 6 sessions of emotion regulation techniques based on the  mentioned book. Each session lasts 45 minutes and two sessions per week. Equipment needed: treatment room with two chairs. Intervention 2: Intervention group: Behavior therapy techniques plus alpha neurofeedback protocol 12 sessions. 6 introductory sessions of mindfulness techniques based on Dr. Linhan's book for 30 minutes. And 15 minutes of mindfulness exercises with the help of pz point neurofeedback device. a8-12. Feedback is audio and the feedback process is blindfolded. Equipment: Neurofeedback device and conductive adhesive and alcohol for cleaning. The second 6 sessions of emotion regulation exercises according to Dr. Linhan's book for 45 minutes During the sessions, the skin conductance sensor will be used to give feedback to the patient on the activity of the autonomic system. Sodium chloride serum equipment for cleaning the index finger and skin conductance sensor.</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:
information will be distroyed

When:
until dissertation submited

To whom:
university department

Conditions:
department checl

Where to obtain:
to researcher

How to obtain:
requesting from department

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mohammad Mahdi Mehrabi Tavana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Nehst2. Manoochehri, Ferdos</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>7896541235</zip>
        <telephone>+98 21 4411 3443</telephone>
        <email>mehdimehrabi22222@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohammad Mahdi Mehrabi Tavana</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Neshat2, Ferdos, Western Ferdos, Tehran</address>
        <city>tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>5454598765</zip>
        <telephone>+98 21 5566 3254</telephone>
        <email>mehdimehrabi22222@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>personality disorder manifestation</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychotic symptom
Bipolar disorder
Addiction</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Borderline personality disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: Behavior therapy techniques 12 sessions. The first 6 sessions of mindfulness techniques based on the latest handbook of Dr. Marsha Linhan and the second 6 sessions of emotion regulation techniques based on the  mentioned book. Each session lasts 45 minutes and two sessions per week. Equipment needed: treatment room with two chairs</i_keyword>
      <i_keyword>Intervention group: Behavior therapy techniques plus alpha neurofeedback protocol 12 sessions. 6 introductory sessions of mindfulness techniques based on Dr. Linhan's book for 30 minutes. And 15 minutes of mindfulness exercises with the help of pz point neurofeedback device. a8-12. Feedback is audio and the feedback process is blindfolded. Equipment: Neurofeedback device and conductive adhesive and alcohol for cleaning. The second 6 sessions of emotion regulation exercises according to Dr. Linhan's book for 45 minutes During the sessions, the skin conductance sensor will be used to give feedback to the patient on the activity of the autonomic system. Sodium chloride serum equipment for cleaning the index finger and skin conductance sensor.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>EMOTION regulation. Timepoint: four time two weekly. Method of measurement: emotion regulation ders.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Alexithymia. Timepoint: every 2 week. Method of measurement: toronto quastionare.</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>Personal-fund</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-03-03</approval_date>
        <contact_name>ethics committtee of university of social welfare and rehabilitation science</contact_name>
        <contact_address>NUMBER19,NESHAT2,MANOOCHERI,WESTERN FERDOS Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
