<?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>IRCT20211223053494N5</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-06-03</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Effectiveness of Cognitive Behavioral Therapy in Dependent Personality Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Effectiveness of Face-to-face Cognitive Behavioral Therapy and Internet-Based Cognitive Behavioral Therapy in People with Dependent Personality Disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-06-05</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/70052</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization will be simple randomization. The randomization unit is individual. Excel software is used for randomization. Subjects will be randomly assigned to two groups, intervention group 1 and intervention group 2, based on the randomization part of Excel. In this way, all the names are entered into Excel and we will create a random number in Excel using the Random Number Generation option in the Toolback Analysis section. Even numbers are in intervention group 1 and odd numbers are in intervention group 2.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Dependent personality disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: includes all clients to psychological treatment centers in Tehran who received face-to-face cognitive behavioral therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions. Intervention 2: Intervention group 2: includes all clients to psychological treatment centers in Tehran who individually received Internet-Based Cognitive Behavioral Therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions.</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 more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Hoda Doos Ali Vand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>doosalivand.h@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hoda Doos Ali Vand</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1983963113</zip>
        <telephone>+98 21 2303 1548</telephone>
        <email>doosalivand.h@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>age range of 18-65 years,
primary diagnosis of Dependent Personality Disorder,
were fluent in Persian.</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Having current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia spectrum disorder, bipolar I disorder, neurocognitive disorder, and substance-related disorder
had a diagnosis of antisocial, schizotypal, schizoid, and borderline personality disorder
were at high risk of suicide
had a history of Cognitive behavioral therapy for the last four years</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F60.7</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Dependent 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 1: includes all clients to psychological treatment centers in Tehran who received face-to-face cognitive behavioral therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions.</i_keyword>
      <i_keyword>Intervention group 2: includes all clients to psychological treatment centers in Tehran who individually received Internet-Based Cognitive Behavioral Therapy (according to the book of Cognitive Behavior Therapy of DSM-5 Personality Disorders, Assessment, Case Conceptualization, and Treatment) for 15 sessions once a week for 60 minutes. The content of the first to third sessions: assessment and Socialization with treatment, behavioral and cognitive intervention training, the content of the fourth to eighth sessions of behavioral intervention training, including assertiveness and communication skills training. Cognitive skills include teaching and practicing problem-solving skills, teaching autonomy and self-control, emotional skills-emotional inhibition and division of emotions; Perceptual skills of having a wide view, stopping thinking, distancing emotionally, physiological skills such as relaxation training and meditation. and performing graded tasks, teaching the connection between spontaneous thoughts and the patient's feelings, teaching the patient to categorize distorted spontaneous thoughts and challenging spontaneous thoughts and dysfunctional schemas related to dependency and disability. The content of the 9th to 15th sessions is the continuation of behavioral and cognitive interventions to identify and challenge spontaneous thoughts during the treatment sessions and preparation for the end of the sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Depression, anxiety and stress score in Lovibond and Lovibond scale (DASS-21). Timepoint: At the beginning of the study (before the intervention), after the intervention. Method of measurement: Depression, Anxiety, Stress Scale (DASS-21).</prim_outcome>
      <prim_outcome>Score of interpersonal problems in Barkham questionnaire. Timepoint: At the beginning of the study (before the intervention), after the intervention. Method of measurement: Inventory of Interpersonal Problems (IIP-32).</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-05-02</approval_date>
        <contact_name>Research Ethics Committees of School of Medicine - Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>School of Medicine, next to the University Headquarters, Shahid Beheshti University of Medical Sciences, Shahid Chamran Evin Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
