<?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>IRCT20231001059577N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-01-18</date_registration>
      <primary_sponsor>University of Kurdistan</primary_sponsor>
      <public_title>The effectiveness of unified transdiagnostic treatment on body dysmorphic disorder comorbid with emotional disorders</public_title>
      <acronym></acronym>
      <scientific_title>The effectiveness of unified transdiagnostic treatment on emotional, cognitive, and neuropsychological symptoms and indicators in individuals with body dysmorphic disorder comorbid with emotional disorders: A clinical trial study</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-01-25</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>34</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/72915</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the people with body dysmorphic disorder comorbid with emotional disorders were selected based on the inclusion and exclusion criteria, they will be allocated to two equal groups of treatment and control using the blocking randomization method. The coin toss method will be used to allocate people in each of the groups (Treatment and control). The blocking method will be used to balance the number of samples assigned to each of the study groups, Blinding description: In this study, a clinical interview will be conducted by a clinical expert therapist to evaluate the inclusion and exclusion criteria. After obtaining informed consent to participate in the research, the participants will be randomly assigned to groups (treatment and control groups), in such a way that the participants have no knowledge of which group (treatment group or control group) they will be placed in. will not have Allocating participants in groups and taking the tests of this research in all three stages (Pre-treatment; post-treatment; follow-up) will be done by someone other than the therapist.</study_design>
      <phase>N/A</phase>
      <hc_freetext>body dysmorphic disorder comorbid with emotional disorders.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies. Intervention 2: Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1.</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:
Part of the data including information about the main consequence can be shared.

When:
Start of accessibility will be one year after printing the results.

To whom:
Data will only be available to researchers working in academic institutions.

Conditions:
Requests for data are only permitted for intercultural studies or the studies of meta-analysis.

Where to obtain:
Researchers can use the mentioned communication channel to receive the desired documents or data.
Email: nasiri.uok@yahoo.com

How to obtain:
Data will be provided by email or post after evaluation of the request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fateme Etaati</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd; University of Kurdistan</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>087-33664600-8</telephone>
        <email>fateme.etaati@uok.ac.ir</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Farzad Nasiri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Pasdaran Blvd; University of Kurdistan</address>
        <city>Sanandaj</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>66177-15175</zip>
        <telephone>087-33664601-2246</telephone>
        <email>nasiri.uok@yahoo.com</email>
        <affiliation>University of Kurdistan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of BDD disorder according to DSM-5
Having a minimum score of 53 in the body image concern inventory of Littleton et al
The presence of at least one emotional disorder
Age range of people from 18 to 45 years
Willing to participate in the study by signing a written consent form
The ability to speak Persian in all assessments
Not having serious mental disorders such as psychosis, bipolar type I or II
Not having suicidal thoughts
No abuse of benzodiazepines, antipsychotics, and SSRI medicines in the last 6 months</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Need for medical intervention
Receiving psychotherapy sessions at the same time
Concerns about weight-related eating disorders
Unwillingness to continue participating at any time in the study
Absence of more than 3 sessions in treatment sessions</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: group 1: UP group. Unified protocol for transdiagnostic of emotional disorders consists of a maximum of 10, 45-minute individual treatment sessions. The UP targets and regulates emotional experiences by increasing emotion awareness and cognitive flexibility; identifying emotion-driven behaviors (EDBs) and replacing them with adaptive behaviors; identifying and preventing patterns of emotion avoidance; increasing awareness and confronting physical sensations, and facing emotions in situations. The treatment is preceded by enhancing the motivation and readiness of individuals for change and treatment engagement. Finally, the treatment ends by considering the progress of treatment and developing relapse prevention strategies.</i_keyword>
      <i_keyword>Control group: wait-list group for Unified protocol.َAfter completion of follow-up sessions of intervention groups, the UP treatment will be applied as intervention group 1.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Score of Body Image Concern from BICI questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Body Image Concern Inventory.</prim_outcome>
      <prim_outcome>Score of depression and Anxiety from DASS-21 questionnaire. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: DASS-21 questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Score of cognitive fusion from CFQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CFQ questionnaire.</sec_outcome>
      <sec_outcome>Score of cognitive emotion regulation from CERQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CERQ questionnaire.</sec_outcome>
      <sec_outcome>Score of cognitive avoidance from CAQ. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: CAQ questionnaire.</sec_outcome>
      <sec_outcome>Score of difficulties in emotion regulation from DERS. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: DERS questionnare.</sec_outcome>
      <sec_outcome>Score of anxiety sensitivity from ASI. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: ASI questionnaire.</sec_outcome>
      <sec_outcome>Score of Problem-solving from Tower of London. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Tower of London software.</sec_outcome>
      <sec_outcome>Score of inhibition from go/no go test. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: Go/no go software.</sec_outcome>
      <sec_outcome>Score of working memory from n-back test. Timepoint: Pre-treatment; post-treatment; follow-up. Method of measurement: N- back software.</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>University of Kurdistan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-12-23</approval_date>
        <contact_name>Ethics committee in biomedical research</contact_name>
        <contact_address>Pasdaran Blvd., University of Kurdistan., Central organization Sanandaj Kurdistan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
