xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06022562</url>
    </required_header>
    <id_info>
      <org_study_id>202302HM008</org_study_id>
      <nct_id>NCT06022562</nct_id>
    </id_info>
    <brief_title>Effects of Gender-affirming Hormone Therapy on Transgender People</brief_title>
    <official_title>Effects of Gender-affirming Hormone Therapy on the Psychosocial and Quality of Life of Transgender People: A Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Taiwan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Taiwan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This prospective cohort study aims to assess the impact of gender-affirming hormone therapy&#xD;
        (GAHT) on transgender individuals' physical, psychological, social, and quality of life&#xD;
        aspects. Based on gender minority stress theory, the research recruits 150 individuals each&#xD;
        of those starting GAHT and those not yet undergoing it. Data collection involves&#xD;
        questionnaires and physiological measurements. Statistical analyses will explore correlations&#xD;
        and group differences. Findings can guide transgender individuals considering hormone therapy&#xD;
        and enhance care guidelines to improve their overall well-being.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The willingness and proportion of transgender persons diagnosed with gender dysphoria to&#xD;
        receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their&#xD;
        internal gender identity. However, there are limited studies on the prospectively observation&#xD;
        of the influences and effectiveness of GAHT on physical, psychological, social and quality of&#xD;
        life of transgender people. This study is a cross-sectional research prospective cohort study&#xD;
        design, and the research framework is developed based on gender minority stress theory. It is&#xD;
        expected to recruit a group of 150 transgender people, including trans male, trans female,&#xD;
        and non-binary person, who have just started using GAHT, and a group of 150 who has not yet&#xD;
        received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires&#xD;
        will be applied to collect basic demographic information, basic hormonal information, body&#xD;
        changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality&#xD;
        of life. The instruments will be applied to measure participants' physiological parameters,&#xD;
        including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the&#xD;
        statistical part, correlation and regression will be used to analyze the degree of&#xD;
        correlation between variables, and multivariate analysis of covariance will be used to detect&#xD;
        whether there was a significant difference between the variables of the two groups. A well&#xD;
        understanding of the experiences and reactions of transgender people receiving hormone&#xD;
        therapy can provide a reference for transgender people before deciding to accept hormone&#xD;
        therapy, and can be used as an important reference for formulating care guidelines for&#xD;
        gender-affirming hormone therapy to improve the care quality for the gender minority&#xD;
        population.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Transgender Congruence Scale</measure>
      <time_frame>1 year</time_frame>
      <description>Participants rated this 15 items scale on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Four of the 15 items were designed to be reverse-scored. Item responses were averaged, with higher scores indicating a higher level of congruence. So the maximum and minimum values of this scale are 75 and 15.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale</measure>
      <time_frame>1 year</time_frame>
      <description>Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sexual Risk Survey (SRS) Items</measure>
      <time_frame>1 year</time_frame>
      <description>Participants rated this 23 items. This questionnaire inquires about the frequency of subjects' experiences with each sexual risk. A higher frequency indicates a greater level of risk.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short Sexual Well Being Scale</measure>
      <time_frame>1 year</time_frame>
      <description>Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Transgender individual Quality of Life</measure>
      <time_frame>1 year</time_frame>
      <description>Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Beck Depression Inventory-II</measure>
      <time_frame>1 year</time_frame>
      <description>The BDI-II, or Beck Depression Inventory-II, is a widely used self-report assessment tool for measuring the severity of depression. It consists of 21 multiple-choice questions or items. Of these 21 items, 13 are scored in the direction of increasing depression severity, while the remaining 8 are reverse-scored to assess positive attributes.&#xD;
  The possible score range on the BDI-II is from 0 to 63, with higher scores indicating more severe depressive symptoms.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Multidimensional Perceived Social Support Scale</measure>
      <time_frame>1 year</time_frame>
      <description>The Multidimensional Perceived Social Support Scale (MPSSS) is a self-report questionnaire designed to assess an individual's perception of the level of social support they receive. It measures support from various sources, such as family, friends, and significant others, and evaluates different dimensions of support, including emotional, instrumental, and informational support. Participants rated this 13 items scale on a 4-point Likert-type scale with 4 different social related group. With higher scores indicates a higher level.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Gender Dysphoria</condition>
    <arm_group>
      <arm_group_label>With gender-affirming hormone therapy</arm_group_label>
      <description>With gender-affirming hormone therapy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Without gender-affirming hormone therapy</arm_group_label>
      <description>Without gender-affirming hormone therapy</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          transgender&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  transgender&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>National Taiwan University</investigator_affiliation>
      <investigator_full_name>Piao-Yi Chiou</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>depression</keyword>
    <keyword>gender-affirming hormone therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gender Dysphoria</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06022562
  org study id: 202302HM008
  nct id: NCT06022562
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This prospective cohort study aims to assess the impact of gender-affirming hormone therapy
        (GAHT) on transgender individuals' physical, psychological, social, and quality of life
        aspects. Based on gender minority stress theory, the research recruits 150 individuals each
        of those starting GAHT and those not yet undergoing it. Data collection involves
        questionnaires and physiological measurements. Statistical analyses will explore correlations
        and group differences. Findings can guide transgender individuals considering hormone therapy
        and enhance care guidelines to improve their overall well-being.
  The willingness and proportion of transgender persons diagnosed with gender dysphoria to
        receive gender-affirming hormone therapy (GAHT) is relatively high, so as to conform to their
        internal gender identity. However, there are limited studies on the prospectively observation
        of the influences and effectiveness of GAHT on physical, psychological, social and quality of
        life of transgender people. This study is a cross-sectional research prospective cohort study
        design, and the research framework is developed based on gender minority stress theory. It is
        expected to recruit a group of 150 transgender people, including trans male, trans female,
        and non-binary person, who have just started using GAHT, and a group of 150 who has not yet
        received GAHT. The data collection time is about 40-50 minutes each time. The questionnaires
        will be applied to collect basic demographic information, basic hormonal information, body
        changes, body image, sexual wellbeing, sexual risk, depression, social support, and quality
        of life. The instruments will be applied to measure participants' physiological parameters,
        including weight, body fat, and muscle mass, hand grip strength, and blood pressure. In the
        statistical part, correlation and regression will be used to analyze the degree of
        correlation between variables, and multivariate analysis of covariance will be used to detect
        whether there was a significant difference between the variables of the two groups. A well
        understanding of the experiences and reactions of transgender people receiving hormone
        therapy can provide a reference for transgender people before deciding to accept hormone
        therapy, and can be used as an important reference for formulating care guidelines for
        gender-affirming hormone therapy to improve the care quality for the gender minority
        population.
  observational model: Case-Control
  time perspective: Cross-Sectional
  measure: Transgender Congruence Scale
  time frame: 1 year
  description: Participants rated this 15 items scale on a 5-point Likert-type scale (i.e., 1 = strongly disagree, 2 = somewhat disagree, 3 = neither agree nor disagree, 4 = somewhat agree, 5 = strongly agree). Four of the 15 items were designed to be reverse-scored. Item responses were averaged, with higher scores indicating a higher level of congruence. So the maximum and minimum values of this scale are 75 and 15.
  measure: Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale
  time frame: 1 year
  description: Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
  measure: Sexual Risk Survey (SRS) Items
  time frame: 1 year
  description: Participants rated this 23 items. This questionnaire inquires about the frequency of subjects' experiences with each sexual risk. A higher frequency indicates a greater level of risk.
  measure: Short Sexual Well Being Scale
  time frame: 1 year
  description: Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.
  measure: Transgender individual Quality of Life
  time frame: 1 year
  description: Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.
  measure: Beck Depression Inventory-II
  time frame: 1 year
  description: The BDI-II, or Beck Depression Inventory-II, is a widely used self-report assessment tool for measuring the severity of depression. It consists of 21 multiple-choice questions or items. Of these 21 items, 13 are scored in the direction of increasing depression severity, while the remaining 8 are reverse-scored to assess positive attributes.
  The possible score range on the BDI-II is from 0 to 63, with higher scores indicating more severe depressive symptoms.
  measure: Multidimensional Perceived Social Support Scale
  time frame: 1 year
  description: The Multidimensional Perceived Social Support Scale (MPSSS) is a self-report questionnaire designed to assess an individual's perception of the level of social support they receive. It measures support from various sources, such as family, friends, and significant others, and evaluates different dimensions of support, including emotional, instrumental, and informational support. Participants rated this 13 items scale on a 4-point Likert-type scale with 4 different social related group. With higher scores indicates a higher level.
  arm group label: With gender-affirming hormone therapy
  description: With gender-affirming hormone therapy
  arm group label: Without gender-affirming hormone therapy
  description: Without gender-affirming hormone therapy
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Principal Investigator
  investigator affiliation: National Taiwan University
  investigator full name: Piao-Yi Chiou
  investigator title: Associate Professor
  mesh term: Gender Dysphoria
  sharing ipd: Undecided