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Effects of Gender-affirming Hormone Therapy on Transgender People

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ClinicalTrials.gov Identifier: NCT06022562
Recruitment Status : Recruiting
First Posted : September 5, 2023
Last Update Posted : January 10, 2024
Sponsor:
Information provided by (Responsible Party):
Piao-Yi Chiou, National Taiwan University

Study Description
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Brief Summary:
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.

Condition or disease
Gender Dysphoria

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Effects of Gender-affirming Hormone Therapy on the Psychosocial and Quality of Life of Transgender People: A Prospective Cohort Study
Actual Study Start Date : January 8, 2024
Estimated Primary Completion Date : July 20, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
With gender-affirming hormone therapy
With gender-affirming hormone therapy
Without gender-affirming hormone therapy
Without gender-affirming hormone therapy


Outcome Measures
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Primary Outcome Measures :
  1. Transgender Congruence Scale [ Time Frame: 1 year ]
    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.

  2. Gender Affirming Hormone Treatment Physical Symptoms Assessment Scale [ Time Frame: 1 year ]
    Participants rated this 17 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.

  3. Sexual Risk Survey (SRS) Items [ Time Frame: 1 year ]
    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.

  4. Short Sexual Well Being Scale [ Time Frame: 1 year ]
    Participants rated this 5 items scale on a 7-point Likert-type scale. With higher scores indicates a higher level.

  5. Transgender individual Quality of Life [ Time Frame: 1 year ]
    Participants rated this 23 items scale on a 4-point Likert-type scale. With higher scores indicates a higher level.

  6. Beck Depression Inventory-II [ Time Frame: 1 year ]

    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.


  7. Multidimensional Perceived Social Support Scale [ Time Frame: 1 year ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
transgender
Criteria

Inclusion Criteria:

  • transgender

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06022562


Locations
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Taiwan
National Taiwan University, College of Medicine, School of Nursing Recruiting
Taipei, Taiwan
Contact: PIAO-YI CHIOU, doctoral    +886-2-23123456 ext 88427    piaoyi@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University
More Information
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Responsible Party: Piao-Yi Chiou, Associate Professor, National Taiwan University
ClinicalTrials.gov Identifier: NCT06022562    
Other Study ID Numbers: 202302HM008
First Posted: September 5, 2023    Key Record Dates
Last Update Posted: January 10, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Piao-Yi Chiou, National Taiwan University:
depression
gender-affirming hormone therapy
Additional relevant MeSH terms:
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Gender Dysphoria
Sexual Dysfunctions, Psychological
Mental Disorders