<?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>IRCT20220705055378N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-08-15</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The Effect of Intensive Short-Term Dynamic Psychotherapy  on Reducing Psychological Symptoms, Increasing Psychological Well-Being and Social Adjustment</public_title>
      <acronym></acronym>
      <scientific_title>The Effect of Intensive Short-Term Dynamic Psychotherapy (ISTDP) on Reducing Psychological Symptoms, Increasing Psychological Well-Being and Social Adjustment of Patients with Antisocial Personality Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>16</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64634</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Consistent with similar studies, this paper selects 16 subjects using the convenience sampling method. Then, randomization will be done using lottery method (a number will be assigned to each subject). We write down the numbers on the paper, fold each paper and then put them in a container. We mix the papers completely. Then we take out the papers one by one and place one number in the first group and one number in the second group, respectively.
Then the randomized trial will be done. So, a group is randomly selected as the "control group" and another group is known as the "intervention group". Thus, to randomly determine the "control group" and the "intervention group", we place each group list in two separate envelopes and put them in a container. Then we randomly take one envelope out of the container and assign it to the "intervention group" and then the second envelope group will be assigned to the "control group".</study_design>
      <phase>N/A</phase>
      <hc_freetext>Antisocial Personality Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will be subjected to Intensive Short Term Dynamic Psychotherapy, (ISTDP), (modified method) twice a week for ten 1-hour sessions. This paper adopts a therapy package derived from Davanloo Intensive Short Term Dynamic Psychotherapy (ISTDP), the modified method. According to the Davanloo method, the therapy first session takes between 1.5 and 3 hours for the evaluations, followed by the one-hour sessions held weekly.This therapy is classified into seven specific stages: -First stage: Experimental therapy. At this stage, we examine the patient's problems and evaluate their initial ability to respond to therapy. At this stage, we discuss the patient's problem nature and ask for an explanation of a specific and objective example of their problem. The process of asking questions about the patient's problems emphasizes providing personal, objective, and specific explanations to clarify what the patient has provided. -Second stage: Emphasize more objective answers and experience feelings. At this stage, the main defense systems are gradually activated in the patient with the therapist's frequent requests to explain objective and specific answers and anxiety-provoking issues. The therapist asks the patient for specific and objective answers. The patient is asked to give an example of the problem causing events , and an attempt is made to direct the interview to anxiety-provoking issues. -Third stage: identifying, clarifying, and challenging the defenses. The defense mechanisms are activated following the therapist's questioning and emphasizing specific answers and experiencing feelings. Then, the therapist enters the stage of analyzing and checking defenses by exerting some pressure on the patient. This method creates the highest level of the ability to experience feelings. Therefore, all defenses against the experience of feeling are identified and challenged to be neutralized. -Fourth stage: transference resistance. In the fourth stage, the therapist takes care of transference symptoms, which are mostly non-verbal. These signs may be used to defend one's rage, including clenching fists, clinging to the chair, tension and cramping, sighing, etc. When the therapist feels that the tension has increased to a suitable level, s/he directs the interview to focus on the transference. And in this process, s/he directs the patient's attention to the non-verbal symptoms that they show. The patient's response to the therapist's question about their feeling is defensive. The therapist continues to clarify, exert pressure and challenge the transference feelings, with the difference that s/he increases the amount of challenge compared to before. And therefore, increasing the challenge causes more transference through the resistance toward transference feelings. -Fifth stage: Direct access to the unconscious. In the fifth stage, focusing on defenses, identifying and clarifying, and challenging them leads to the intense and complex motions of transference feelings in the patient. The pressure and challenge continue until the unconscious shows signs that feelings and impulses are approaching the surface. All three components of a feeling must be experienced for full penetration and real touching of feelings. -Sixth stage: Systematic analysis of transference. Transference analysis at this stage consists of communicating and analyzing the similarities between the patient’s communication pattern in transfer with their other relationships in their current and past life. At this stage, the therapist analyzes the transfer using the triangle of conflict and the triangle of person. - Seventh stage: Dynamic exploration of the unconscious.  In the seventh stage traumatic events causing anxiety and unconscious feelings of rage, sadness, and guilt are revealed and experienced for the dominance of the therapeutic alliance. The therapist helps the person gain insight into them, and explores the patient's current and past relationships following the systematic analysis of the transference and the triangle of conflict, and the triangle of person. The therapist uses the triangle of conflict, and the triangle of person to analyze the disclosed issues. Exploring the patient's family life and past is essential at this stage. Having collected sufficient evidence from the patient's past, the therapist makes their questions more dynamic through which the patient's conflict structure and core disorder are clarified. The second to the tenth sessions are held under the first session steps protocol, and then the follow-up sessions are held based on the triangle of conflict, and the triangle of person, and other problems. Intervention 2: Control group: No intervention is done for the control group. Before the intervention, a pre-test was taken from the control group and they were put on the waiting list. At the end of the intervention, they will be given a post-test and the results will be analyzed.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Nima Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no. 222, Shahid Tahanian st., Semnan</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514616791</zip>
        <telephone>+98 23 3329637</telephone>
        <email>nimasalehian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Nima Salehian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No.222, Shahid Tahanian St., Bagh Ferdous st., Semnan Iran</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3514616791</zip>
        <telephone>+98 919 881 7352</telephone>
        <email>nimasalehian@yahoo.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with Antisocial Personality Disorder Based on the Minimum Score of Milon questionnaire 3  (MCMI-III)
Men in the Age Range of 18 to 45 Years
A Resident of Semnan Prison
Confirmation of Antisocial Personality Disorder Based on Clinical Interview</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>45 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Psychotic Disorders of Drug or Alcohol Abuse
Mental Retardation Disorders
Any Problem with Impulse Control
The Presence of Psychosis
Bipolar Mood Disorder</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.2</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Antisocial 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>Intervention group: They will be subjected to Intensive Short Term Dynamic Psychotherapy, (ISTDP), (modified method) twice a week for ten 1-hour sessions. This paper adopts a therapy package derived from Davanloo Intensive Short Term Dynamic Psychotherapy (ISTDP), the modified method. According to the Davanloo method, the therapy first session takes between 1.5 and 3 hours for the evaluations, followed by the one-hour sessions held weekly.This therapy is classified into seven specific stages: -First stage: Experimental therapy. At this stage, we examine the patient's problems and evaluate their initial ability to respond to therapy. At this stage, we discuss the patient's problem nature and ask for an explanation of a specific and objective example of their problem. The process of asking questions about the patient's problems emphasizes providing personal, objective, and specific explanations to clarify what the patient has provided. -Second stage: Emphasize more objective answers and experience feelings. At this stage, the main defense systems are gradually activated in the patient with the therapist's frequent requests to explain objective and specific answers and anxiety-provoking issues. The therapist asks the patient for specific and objective answers. The patient is asked to give an example of the problem causing events , and an attempt is made to direct the interview to anxiety-provoking issues. -Third stage: identifying, clarifying, and challenging the defenses. The defense mechanisms are activated following the therapist's questioning and emphasizing specific answers and experiencing feelings. Then, the therapist enters the stage of analyzing and checking defenses by exerting some pressure on the patient. This method creates the highest level of the ability to experience feelings. Therefore, all defenses against the experience of feeling are identified and challenged to be neutralized. -Fourth stage: transference resistance. In the fourth stage, the therapist takes care of transference symptoms, which are mostly non-verbal. These signs may be used to defend one's rage, including clenching fists, clinging to the chair, tension and cramping, sighing, etc. When the therapist feels that the tension has increased to a suitable level, s/he directs the interview to focus on the transference. And in this process, s/he directs the patient's attention to the non-verbal symptoms that they show. The patient's response to the therapist's question about their feeling is defensive. The therapist continues to clarify, exert pressure and challenge the transference feelings, with the difference that s/he increases the amount of challenge compared to before. And therefore, increasing the challenge causes more transference through the resistance toward transference feelings. -Fifth stage: Direct access to the unconscious. In the fifth stage, focusing on defenses, identifying and clarifying, and challenging them leads to the intense and complex motions of transference feelings in the patient. The pressure and challenge continue until the unconscious shows signs that feelings and impulses are approaching the surface. All three components of a feeling must be experienced for full penetration and real touching of feelings. -Sixth stage: Systematic analysis of transference. Transference analysis at this stage consists of communicating and analyzing the similarities between the patient’s communication pattern in transfer with their other relationships in their current and past life. At this stage, the therapist analyzes the transfer using the triangle of conflict and the triangle of person. - Seventh stage: Dynamic exploration of the unconscious.  In the seventh stage traumatic events causing anxiety and unconscious feelings of rage, sadness, and guilt are revealed and experienced for the dominance of the therapeutic alliance. The therapist helps the person gain insight into them, and explores the patient's current and past relationships following the systematic analysis of the transference and the triangle of conflict, and the triangle of person. The therapist uses the triangle of conflict, and the triangle of person to analyze the disclosed issues. Exploring the patient's family life and past is essential at this stage. Having collected sufficient evidence from the patient's past, the therapist makes their questions more dynamic through which the patient's conflict structure and core disorder are clarified. The second to the tenth sessions are held under the first session steps protocol, and then the follow-up sessions are held based on the triangle of conflict, and the triangle of person, and other problems.</i_keyword>
      <i_keyword>Control group: No intervention is done for the control group. Before the intervention, a pre-test was taken from the control group and they were put on the waiting list. At the end of the intervention, they will be given a post-test and the results will be analyzed.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Clinical Psychological Symptoms: The score obtained from the Revised 90-Item Symptom Checklist Questionnaire by Drugatis (SCL90) (1984). Timepoint: Measurement periods at the beginning of the study, one week before the intervention and one week after the intervention (i.e. after 10 sessions (35 days) of short-term intensive dynamic psychotherapy intervention). Method of measurement: Revised 90-Item Symptom Checklist (SCL90) by Drugatis (1984).</prim_outcome>
      <prim_outcome>Social Adjustment: The score obtained from the Bell's Social Adjustment Questionnaire (1961). Timepoint: Measurement periods at the beginning of the study, one week before the intervention and one week after the intervention (i.e. after 10 sessions (35 days) of short-term intensive dynamic psychotherapy intervention). Method of measurement: Bell's social adjustment questionnaire (1961).</prim_outcome>
      <prim_outcome>Psychological Well-Being: The score obtained from the Riff Psychological Well-Being Questionnaire (2002). Timepoint: Measurement periods at the beginning of the study, one week before the intervention and one week after the intervention (i.e. after 10 sessions (35 days) of short-term intensive dynamic psychotherapy intervention). Method of measurement: Riff Psychological Well-Being Questionnaire (2002).</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-05-24</approval_date>
        <contact_name>Research Ethics Committee in Islamic Azad University- Semnan Branch</contact_name>
        <contact_address>Islamic Azad University of Semnan, Shahrak Daneshgahi Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
