<?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>IRCT20210903052368N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-10-27</date_registration>
      <primary_sponsor>Kashan University of Medical Sciences</primary_sponsor>
      <public_title>The effect of acceptance &amp; commitment therapy in body dysmorphic disorders symptoms</public_title>
      <acronym></acronym>
      <scientific_title>The effect of acceptance &amp; commitment therapy on body image flexibility, cognitive fusion and emotional symptoms in youth with body dysmorphic disorders symptoms</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-11-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/58491</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Permuted block randomization. Samples are divided into two random groups with 3 and 6 blocks according to the Permuted block randomization method, so all patients will be randomly divided into one of two groups (ACT recipient and control group without psychotherapy). We use random allocation concealment, which is the method used to execute random sequences on study participants. In such a way that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with a random sequence, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants to study one of the envelopes, the order is opened and the assigned group of the participant is revealed.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Body Dysmorphic Disorder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: This study investigates the effect of acceptance and commitment therapy on body image flexibility, cognitive fusion and emotional symptoms in youth with body dysmorphic disorder symptoms in Kashan. This treatment program includes 8 sessions of 90 minutes that are held weekly. Session 1: Creating a treatment contract, introducing treatment, examining the details of a person's dysfunctional thoughts and actions, introducing creative frustration. Session 2: Use the metaphors to show the subject how trying to regulate painful inner experiences is ultimately ineffective. Sessions 3 &amp; 4: Focus on showing how trying to control rather than reduce it exacerbates the disorder. Session 5 &amp; 6: Focus on changing psychological functions using cognitive defusion, mindfulness exercises and Exercises as a Context. Sessions 7 &amp; 8: Explain the values of each subject and increase behavioral commitment to a more sustainable life. Finally, the therapist helps the subject to use himself / herself as a context and participate in valuable activities in order to prevent the return of the symptoms of the exercises learned in the sessions, such as acceptance, mindfulness, cognitive defusion. The purpose of this method is not to change impaired body perception by changing or eliminating negative thoughts and feelings about the body image; Rather, it is done by creating mental flexibility and increasing acceptance of body shape. This treatment lasts eight weekly sessions for each session of ninety minutes for eight weeks. Intervention 2: Control group: This group contains general psychology topics, that has no therapeutic aspect. This group, like the treatment of acceptance and commitment, includes eight weekly sessions with a duration of ninety minutes per session. In each session, one of the stages of psychosocial development of Ericsson theory is taught.Trust vs. Mistrust (1),Autonomy vs. Shame/Doubt(2),Initiative vs. Guilt(3),Industry vs. Inferiority(4),Identity vs. Role Confusion(5),Intimacy vs. Isolation(6),Generativity vs. Stagnation(7),Ego Integrity vs. Despair(8) will be done.</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:
Only part of the information, such as information about the main outcome or the like, and the demographic information, can be shared.

When:
The start of the access period will be available 2 years after the results are published one year later.

To whom:
Only available to scholars working in academic and academic institutions.

Conditions:
In the case of any use, the names of the rsearchers must be mentioned in acknowledgments, no one has the right to use the data for inhumane experiments. Submitting an application should be in accordance with the usual academic procedure and be reviewed for a month. One should not have any connection with anti-human and terrorist organizations.

Where to obtain:
a.torkian73@yahoo.com Akram Torkian Valashani Kashan University of Medical Sciences Faculty of Medicine, Kashan, Iran.

How to obtain:
It will be assessed and answered by the reasercher.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Abdollah Omidi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd, Kashan, IRAN</address>
        <city>kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>abomidi20@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Torkian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>5th of Qotb –e Ravandi Blvd, Kashan, IRAN</address>
        <city>Kashan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8715988141</zip>
        <telephone>+98 31 5554 0021</telephone>
        <email>a.torkian73@yahoo.com</email>
        <affiliation>Kashan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>18-30 years old
Obtaining a score upper than 20 in the Y-BOCS-BDD Questionnaire</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>30 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Substance &amp; drug uses
Using psychiatric medicine
Personality disorders
Psychosis disorder
Eating disorders</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F45.22</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Body dysmorphic disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Behavior</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: This study investigates the effect of acceptance and commitment therapy on body image flexibility, cognitive fusion and emotional symptoms in youth with body dysmorphic disorder symptoms in Kashan. This treatment program includes 8 sessions of 90 minutes that are held weekly. Session 1: Creating a treatment contract, introducing treatment, examining the details of a person's dysfunctional thoughts and actions, introducing creative frustration. Session 2: Use the metaphors to show the subject how trying to regulate painful inner experiences is ultimately ineffective. Sessions 3 &amp; 4: Focus on showing how trying to control rather than reduce it exacerbates the disorder. Session 5 &amp; 6: Focus on changing psychological functions using cognitive defusion, mindfulness exercises and Exercises as a Context. Sessions 7 &amp; 8: Explain the values of each subject and increase behavioral commitment to a more sustainable life. Finally, the therapist helps the subject to use himself / herself as a context and participate in valuable activities in order to prevent the return of the symptoms of the exercises learned in the sessions, such as acceptance, mindfulness, cognitive defusion. The purpose of this method is not to change impaired body perception by changing or eliminating negative thoughts and feelings about the body image; Rather, it is done by creating mental flexibility and increasing acceptance of body shape. This treatment lasts eight weekly sessions for each session of ninety minutes for eight weeks.</i_keyword>
      <i_keyword>Control group: This group contains general psychology topics, that has no therapeutic aspect. This group, like the treatment of acceptance and commitment, includes eight weekly sessions with a duration of ninety minutes per session. In each session, one of the stages of psychosocial development of Ericsson theory is taught.Trust vs. Mistrust (1),Autonomy vs. Shame/Doubt(2),Initiative vs. Guilt(3),Industry vs. Inferiority(4),Identity vs. Role Confusion(5),Intimacy vs. Isolation(6),Generativity vs. Stagnation(7),Ego Integrity vs. Despair(8) will be done.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Body Dysmorphic Disorder. Timepoint: Before intervention, After intervention. Method of measurement: Y-BOCS-BDD Questionnaire.</prim_outcome>
      <prim_outcome>Body Image Flexibility. Timepoint: Before intervention, After intervention. Method of measurement: Body Image – Acceptance &amp; Action Questionnaire.</prim_outcome>
      <prim_outcome>Emotional Symptoms. Timepoint: Before intervention, After intervention. Method of measurement: Depression, Anxiety, Stress Scale (DASS).</prim_outcome>
      <prim_outcome>Cognitive Fusion Questionnaire. Timepoint: Before intervention, After intervention. Method of measurement: Cognitive Fusion.</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>Kashan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-20</approval_date>
        <contact_name>Ethics committee of Kashan University of Medical Sciences Faculty of Medicine</contact_name>
        <contact_address>5th of Qotb –e Ravandi Blvd. Kashan iran Kashan Isfehan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
