<?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>IRCT20211006052690N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-26</date_registration>
      <primary_sponsor>The Ferdowsi University of Mashhad</primary_sponsor>
      <public_title>Effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms, Fear of Negative and Positive Evaluation in Individuals with Social Anxiety Disorder</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms, Fear of Negative and Positive Evaluation in Individuals with Social Anxiety Disorder: Single Subject Design</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-10-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>12</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59393</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Social Anxiety Disorder.</hc_freetext>
      <i_freetext>Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Pharmacological intervention will not be used in this research. The treatment protocol is based on the book "Contextual Schema Therapy; An Integrative Approach to Personality Disorders, Emotional Dysregulation, and Interpersonal Functioning." The authors of this book are Eckhard Roediger, Bruce  A. Stevens and Robert Brockman. Contextual Schema Therapy interweaves conceptual underpinnings of Schema Therapy with cuttingedge theoretical advances, contextualizing it within the framework of Second and Third Wave psychotherapy approaches.This model integrates the important concepts of Third Wave approaches such as Mentalization, Mindfulness, Acceptance, Metacognition, and human values into the basic Schema Therapy model. Contextual Schema Therapy uses the Third Wave therapeutic approaches to break through detachment; to confront harmful internal messengers; and to access and protect Vulnerable Modes, while strengthening the Healthy Adult Mode in order to thwart self-defeating patterns in favor of healthier responses. Therefore, the reason for naming this model as Contextual Schema Therapy is that it has been revised in light of contemporary contributions and understandings from Third Wave therapies. Sessions 1 to 3: Establishing the therapeutic relationship- Assessment- Preparing the problem list- Conceptualizing according to the Schema Therapy approach- Providing psychological education about the Contextual Schema Therapy model (Early Maladaptive Schemas, how they are formed and their continuation, explanation about the Modes and the Mode Model)- Providing an explanation of the descriptive diagram of the subject's modes and the Dimensional Mode Map. Sessions 4 to 6: Dealing with the Coping Modes, including identifying and labeling them, examining their advantages and disadvantages in the past and present (for Avoidant Coping Modes: reviewing the history and functional analysis of these Modes- for Submissive Coping Mode: using empathetic confrontation to access constructive anger- for Overcompensatory Coping Modes: highlighting the need for attachment). Using the Chair technique to bypass the Coping Modes and thus access to the Child Modes and Critical Modes- Identifying and meet the needs of the Child Modes- Identifying the Inner Critical Mode beliefs and addressing them through the Acceptance and Commitment approach: identifying and translating them into Second person and creating inconsistency, putting them on a chair, examining the negative effects of these beliefs on the person, using metaphors to defuse these beliefs and increasing the focus on the present- Strengthening the Healthy Adult Mode: using ACT and Mindfulness Techniques (such as Mindfulness of Breath Meditation, the 5–4–3 exercise, the Emotion Surfing, Self-Compassion exercise and The Eightieth Birthday imagery exercise to identify values)- Planning to do these exercises in the interval between sessions. Teaching how to complete the Mode Monitoring Form. Sessions 7 to 10: Presenting the logic of the Experiential techniques and Imagery Exercises– Imaging the important life events- Re-parenting and re-framing the events- if necessary, use the Chair technique to bypass the Coping Modes, Identifying and meet Needs of the Child Modes- Developing behavioral solutions for the interval between sessions- Preparing an audio file of Imagery exercises to listen to them 1-2 times in the interval between sessions. Sessions 11-13: Increasing the performance of the Healthy Adult Mode through the Two-Chair technique and creating a dialogue between the Healthy Adult Mode and Inner Critic Mode- Teaching the use of Schema-Mode flash cards and preparing a daily conversation notebook to write down the negative beliefs of the Inner Critic Mode and Adult Healthy Mode responses to them. Sessions 14 to 16: Preparing a list of behavioral problems- Developing the Behavioral Experiment and practice in the session in two ways: the Future-directed Imagery to plan behavior and fill out the form of behavioral activation or role-playing- Summarizing tips- helping to consolidate what has been learned through talking about obstacles and setbacks- Talking about ending treatment and expressing feelings about it..</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 This data may be misused by individuals and reported as data from other research.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Issac Rahimian Boogar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology., Faculty of Psychology and Educational Sciences., Semnan University., Mahdishahr, Semnan, Iran.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111556</zip>
        <telephone>+982333623300- +982333624250</telephone>
        <email>i_rahimian@semnan.ac.ir</email>
        <affiliation>The Semnan University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Issac Rahimian Boogar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Clinical Psychology., Faculty of Psychology and Educational Sciences., Semnan University., Mahdishahr, Semnan, Iran.</address>
        <city>Semnan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3564111556</zip>
        <telephone>+982333623300- +982333624250</telephone>
        <email>i_rahimian@semnan.ac.ir</email>
        <affiliation>The Semnan University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of Social Anxiety Disorder based on Structured Clinical Interview for DSM-5 (SCID-5)
Age range 20 to 30 Years
Level of education, minimum diploma
Consent of the participants to attend the treatment sessions</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Psychiatric disorders such as psychotic disorders and personality disorders and comorbid disorders such as other anxiety disorders, mood disorders, body dysmorphic disorder and substance use disorders
Addictive behaviors such as Internet Addiction (measured in the context of the interview)
Medical disorders (assessment by reviewing the file and medical history)
Receiving simultaneous psychological interventions</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F40.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Social phobias</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Pharmacological intervention will not be used in this research. The treatment protocol is based on the book "Contextual Schema Therapy; An Integrative Approach to Personality Disorders, Emotional Dysregulation, and Interpersonal Functioning." The authors of this book are Eckhard Roediger, Bruce  A. Stevens and Robert Brockman. Contextual Schema Therapy interweaves conceptual underpinnings of Schema Therapy with cuttingedge theoretical advances, contextualizing it within the framework of Second and Third Wave psychotherapy approaches.This model integrates the important concepts of Third Wave approaches such as Mentalization, Mindfulness, Acceptance, Metacognition, and human values into the basic Schema Therapy model. Contextual Schema Therapy uses the Third Wave therapeutic approaches to break through detachment; to confront harmful internal messengers; and to access and protect Vulnerable Modes, while strengthening the Healthy Adult Mode in order to thwart self-defeating patterns in favor of healthier responses. Therefore, the reason for naming this model as Contextual Schema Therapy is that it has been revised in light of contemporary contributions and understandings from Third Wave therapies. Sessions 1 to 3: Establishing the therapeutic relationship- Assessment- Preparing the problem list- Conceptualizing according to the Schema Therapy approach- Providing psychological education about the Contextual Schema Therapy model (Early Maladaptive Schemas, how they are formed and their continuation, explanation about the Modes and the Mode Model)- Providing an explanation of the descriptive diagram of the subject's modes and the Dimensional Mode Map. Sessions 4 to 6: Dealing with the Coping Modes, including identifying and labeling them, examining their advantages and disadvantages in the past and present (for Avoidant Coping Modes: reviewing the history and functional analysis of these Modes- for Submissive Coping Mode: using empathetic confrontation to access constructive anger- for Overcompensatory Coping Modes: highlighting the need for attachment). Using the Chair technique to bypass the Coping Modes and thus access to the Child Modes and Critical Modes- Identifying and meet the needs of the Child Modes- Identifying the Inner Critical Mode beliefs and addressing them through the Acceptance and Commitment approach: identifying and translating them into Second person and creating inconsistency, putting them on a chair, examining the negative effects of these beliefs on the person, using metaphors to defuse these beliefs and increasing the focus on the present- Strengthening the Healthy Adult Mode: using ACT and Mindfulness Techniques (such as Mindfulness of Breath Meditation, the 5–4–3 exercise, the Emotion Surfing, Self-Compassion exercise and The Eightieth Birthday imagery exercise to identify values)- Planning to do these exercises in the interval between sessions. Teaching how to complete the Mode Monitoring Form. Sessions 7 to 10: Presenting the logic of the Experiential techniques and Imagery Exercises– Imaging the important life events- Re-parenting and re-framing the events- if necessary, use the Chair technique to bypass the Coping Modes, Identifying and meet Needs of the Child Modes- Developing behavioral solutions for the interval between sessions- Preparing an audio file of Imagery exercises to listen to them 1-2 times in the interval between sessions. Sessions 11-13: Increasing the performance of the Healthy Adult Mode through the Two-Chair technique and creating a dialogue between the Healthy Adult Mode and Inner Critic Mode- Teaching the use of Schema-Mode flash cards and preparing a daily conversation notebook to write down the negative beliefs of the Inner Critic Mode and Adult Healthy Mode responses to them. Sessions 14 to 16: Preparing a list of behavioral problems- Developing the Behavioral Experiment and practice in the session in two ways: the Future-directed Imagery to plan behavior and fill out the form of behavioral activation or role-playing- Summarizing tips- helping to consolidate what has been learned through talking about obstacles and setbacks- Talking about ending treatment and expressing feelings about it.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Emotion regulation score in the Emotion Regulation Questionnaire (ERQ). Timepoint: The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated. Method of measurement: Emotion Regulation Questionnaire (ERQ).</prim_outcome>
      <prim_outcome>Interpersonal Problems score in the Inventory of Interpersonal Problems (IIP-32). Timepoint: The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated. Method of measurement: Inventory of Interpersonal Problems (IIP-32).</prim_outcome>
      <prim_outcome>Score of Painful Physical Symptoms in the Visual Analogue Scale (VAS). Timepoint: The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated. Method of measurement: Visual Analogue Scale (VAS).</prim_outcome>
      <prim_outcome>Fear of Negative Evaluation score in the Brief Fear of Negative Evaluation-II (BFNE-II). Timepoint: The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated. Method of measurement: Brief Fear of Negative Evaluation-II (BFNE-II).</prim_outcome>
      <prim_outcome>Fear of Positive Evaluation score on the Fear of Positive Evaluation Scale (FPES). Timepoint: The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated. Method of measurement: Fear of Positive Evaluation Scale (FPES).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name>The Semnan University</sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The Ferdowsi University of Mashhad</source_name>
      <source_name>The Semnan University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-08-24</approval_date>
        <contact_name>Ethics Committee of Semnan University of Medical Sciences</contact_name>
        <contact_address>Semnan University of Medical Sciences and Health Services., Basij Blvd., Semnan., Semnan province. Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
