<?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>IRCT20230801058999N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-10-18</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>The effect of teaching dialectical behavior therapy skills in transgender people</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of Teaching Dialectical Behavior Therapy Skills on resilience and reducing internalized transphobia of transgender people</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>18</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/71876</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Transgender people.</hc_freetext>
      <i_freetext>Intervention group: Intervention group: Transgender people referring to the Transgender Center of Ibn Sina Mashhad Hospital and Mashhad Forensic Medicine in 1402-1403.                                                                                This research will be done as a semi-experimental before-and-after type. And each person will be his own control. The sample members are selected by a simple random method. After selecting the participants, the training program of dialectical behavior therapy skills will be implemented on the experimental group in 10 sessions of 90 minutes, twice a week, under the supervision of the relevant professor, and in each session 20 People will participate and the patients will be asked to complete the tasks that are needed to consolidate the training and better effectiveness of the treatment. Connor and Davidson Resilience Questionnaire (CD-RISC) and internalized transphobia (IT) will be administered before the intervention (day zero) and at the end of the training as a post-test to ensure the stability of the results over time one month later. The results of the treatment are followed up after the sessions.                                                           The content of the dialectical behavior therapy training sessions:                                    first session: stating the rules of group therapy sessions; including the purpose of holding the meetings, the duration and number of meetings, the conditions for exiting the meetings and answering the questions of the participants in this field. The definition of the term dialectic and the principles and methods underlying thinking and behavior in the dialectical behavior therapy approach, familiarization and explanation of pervasive awareness and emotional, rational and logical states of mind.                                        The second session: the centrality of teaching the basic skills of distress tolerance; including relaxation and self-soothing, turning attention from self-harming behaviors to pleasurable activities, leaving the situation and diverting attention to another issue                                                                                       The third session: the centrality of teaching advanced distress tolerance skills; Among them, visualizing a safe place, living in the present moment, discovering individual values, accepting fundamentals, formulating new coping strategies and coping plans in stressful situations.                                                      The fourth session: the centrality of teaching the fundamental skills of mindfulness; Among them, neglecting and mindfulness and practicing it. The fifth session: the centrality of teaching advanced skills of mindfulness; Among them, the wise mind, fundamental acceptance and initiatory mind, judgments and labels, non-judgment and everyday experience, the application of mindfulness in relationships and daily life, and recognizing and examining the obstacles ahead in performing mindfulness exercises.                                                                                 The sixth session: focusing on the fundamental skills of emotional regulation; Among them, the recognition of emotions and the process of emotion regulation, overcoming the obstacles to experiencing healthy emotions, reducing physical vulnerability to disturbing emotions and increasing the experience of positive emotions.                                                                The seventh session: focusing on teaching advanced emotional regulation skills; including, paying mindfulness to emotions without judging them, how to face positive and negative emotions, acting against strong emotional desires and problem solving                                                            The eighth session: focusing on the fundamental skills of effective communication; Among them, recognizing passive-aggressive behavior, compatibility between my desires and the desires of others, proportionality of individual desires and needs, learning key interpersonal skills and knowing the obstacles to their use.                                     Session 9: Focusing on education Advanced effective communication skills; including identifying demands, adjusting the intensity of demands, bold draft, bold listening, saying no, and how to negotiate and analyze interpersonal problems.                                                                                  The 10th session: summarizing and reviewing what was presented in the entire sessions, evaluating the amount of results obtained from the sessions and the therapeutic goals of the content of the sessions based on McKay, Wood and Brantley behavioral therapy techniques..</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:
All data can be shared after de-identifying people.

When:
Access starts 6 months after results are published

To whom:
The data will be accessible to the editor-in-chief of the journal in which the article was published and to the researchers working in academic and scientific institutions if they provide valid reasons.

Conditions:
It can be used if valid reasons are presented to the responsible author.

Where to obtain:
Dr. Farshad Sheibani: sheibanifr@mums.ac.ir
Mohaddese Sadeghi: sadeghimd991@mums.ac.ir

How to obtain:
After sending the request by mentioning the reasons to the entered emails, the authors will send the data file or the data access code which is registered in valid databases to the applicant after checking and if they agree with this request.

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Farshad Sheibani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Psychiatric Hospital, next to Astan Quds Razavi,  Haramali St.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>919583134</zip>
        <telephone>00983712701-7</telephone>
        <email>sheibanifr@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohaddese Sadeghi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ibn Sina Psychiatric Hospital, next to Astan Quds Razavi,  Haramali St.</address>
        <city>Mashahad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>919583134</zip>
        <telephone>+98 51 3712 7017</telephone>
        <email>sadeghimd991@mums.ac.ir</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of gender dysphoria based on DSM5 in the medical record, this term is considered equivalent to transgender identity in this study.
Ability to understand therapeutic content
Minimum Middle school  education
Age 18 to 50 years
Complete the informed consent form
life in Iran</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>History of active phase of acute medical or psychiatric diseases in the last 6 months</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F64.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gender identity disorders                                                                                      Transsexualism: A desire to live and be accepted as a member of the opposite sex, usually accompanied by a sense of discomfort with, or inapprop</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group: Transgender people referring to the Transgender Center of Ibn Sina Mashhad Hospital and Mashhad Forensic Medicine in 1402-1403.                                                                                This research will be done as a semi-experimental before-and-after type. And each person will be his own control. The sample members are selected by a simple random method. After selecting the participants, the training program of dialectical behavior therapy skills will be implemented on the experimental group in 10 sessions of 90 minutes, twice a week, under the supervision of the relevant professor, and in each session 20 People will participate and the patients will be asked to complete the tasks that are needed to consolidate the training and better effectiveness of the treatment. Connor and Davidson Resilience Questionnaire (CD-RISC) and internalized transphobia (IT) will be administered before the intervention (day zero) and at the end of the training as a post-test to ensure the stability of the results over time one month later. The results of the treatment are followed up after the sessions.                                                           The content of the dialectical behavior therapy training sessions:                                    first session: stating the rules of group therapy sessions; including the purpose of holding the meetings, the duration and number of meetings, the conditions for exiting the meetings and answering the questions of the participants in this field. The definition of the term dialectic and the principles and methods underlying thinking and behavior in the dialectical behavior therapy approach, familiarization and explanation of pervasive awareness and emotional, rational and logical states of mind.                                        The second session: the centrality of teaching the basic skills of distress tolerance; including relaxation and self-soothing, turning attention from self-harming behaviors to pleasurable activities, leaving the situation and diverting attention to another issue                                                                                       The third session: the centrality of teaching advanced distress tolerance skills; Among them, visualizing a safe place, living in the present moment, discovering individual values, accepting fundamentals, formulating new coping strategies and coping plans in stressful situations.                                                      The fourth session: the centrality of teaching the fundamental skills of mindfulness; Among them, neglecting and mindfulness and practicing it. The fifth session: the centrality of teaching advanced skills of mindfulness; Among them, the wise mind, fundamental acceptance and initiatory mind, judgments and labels, non-judgment and everyday experience, the application of mindfulness in relationships and daily life, and recognizing and examining the obstacles ahead in performing mindfulness exercises.                                                                                 The sixth session: focusing on the fundamental skills of emotional regulation; Among them, the recognition of emotions and the process of emotion regulation, overcoming the obstacles to experiencing healthy emotions, reducing physical vulnerability to disturbing emotions and increasing the experience of positive emotions.                                                                The seventh session: focusing on teaching advanced emotional regulation skills; including, paying mindfulness to emotions without judging them, how to face positive and negative emotions, acting against strong emotional desires and problem solving                                                            The eighth session: focusing on the fundamental skills of effective communication; Among them, recognizing passive-aggressive behavior, compatibility between my desires and the desires of others, proportionality of individual desires and needs, learning key interpersonal skills and knowing the obstacles to their use.                                     Session 9: Focusing on education Advanced effective communication skills; including identifying demands, adjusting the intensity of demands, bold draft, bold listening, saying no, and how to negotiate and analyze interpersonal problems.                                                                                  The 10th session: summarizing and reviewing what was presented in the entire sessions, evaluating the amount of results obtained from the sessions and the therapeutic goals of the content of the sessions based on McKay, Wood and Brantley behavioral therapy techniques.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Resilience. Timepoint: before the start of the study, the day of the end of the training and 1 month after the completion of the training. Method of measurement: Connor and Davidson Resilience Questionnaire.</prim_outcome>
      <prim_outcome>Internalized Transphobia. Timepoint: before the start of the study, the day of the end of the training and 1 month after the completion of the training. Method of measurement: The 8-item subscale of internalized transphobia from the Minority Stress and Resilience Questionnaire of Testa et al.</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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-06-21</approval_date>
        <contact_name>Ethics committee of Mashhad Univesity of Medical Sciences</contact_name>
        <contact_address>Central Organization of Qurashi Building, University Street Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
