Interdisciplinary, internet-based trans health care (i²TransHealth): study protocol for a randomised controlled trial

Timo O Nieder, Janis Renner, Antonia Zapf, Susanne Sehner, Amra Hot, Hans-Helmut König, Judith Dams, Thomas Grochtdreis, Peer Briken, Arne Dekker, Timo O Nieder, Janis Renner, Antonia Zapf, Susanne Sehner, Amra Hot, Hans-Helmut König, Judith Dams, Thomas Grochtdreis, Peer Briken, Arne Dekker

Abstract

Introduction: Living in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants' place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers' perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network?

Methods and analysis: In a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth.

Ethics and dissemination: Positive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications.

Trial registration number: NCT04290286.

Protocol version: 22 December 2021 (V.1.0).

Keywords: health economics; mental health; sexual medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the RCT. GD: gender dysphoria; GIC: gender incongruence; RCT: randomised controlled trial.

References

    1. T'Sjoen G, Arcelus J, De Vries ALC, et al. . European Society for Sexual Medicine Position Statement "Assessment and Hormonal Management in Adolescent and Adult Trans People, With Attention for Sexual Function and Satisfaction". J Sex Med 2020;17:570–84. 10.1016/j.jsxm.2020.01.012
    1. Council of the European Union . Council Recommendation of 8 June 2009 on an action in the field of rare diseases. Off J Eur Union, 2009 C 151/02 2009;C 151/02:4, 2009.
    1. Institute of Medicine (US) Committee on the Health Professions Education Summit . Health professions education: a bridge to quality. Washington (DC: National Academies Press (US), 2003.
    1. National Action League for People with Rare Diseases . National plan of action for people with rare diseases. Bonn 2013.
    1. Murad MH, Elamin MB, Garcia MZ, et al. . Hormonal therapy and sex reassignment: a systematic review and meta-analysis of quality of life and psychosocial outcomes. Clin Endocrinol 2010;72:214–31. 10.1111/j.1365-2265.2009.03625.x
    1. Coleman E, Bockting W, Botzer M, et al. . Standards of care for the health of transsexual, transgender, and gender-nonconforming people, version 7. Int J Transgend 2012;13:165–232. 10.1080/15532739.2011.700873
    1. Collin L, Reisner SL, Tangpricha V, et al. . Prevalence of transgender depends on the "case" definition: a systematic review. J Sex Med 2016;13:613–26. 10.1016/j.jsxm.2016.02.001
    1. Nieder TO, Eyssel J, Köhler A. Being trans without medical transition: exploring characteristics of trans individuals from Germany not seeking Gender-Affirmative medical interventions. Arch Sex Behav 2020;49:2661–72. 10.1007/s10508-019-01559-z
    1. Burgwal A, Gvianishvili N, Hård V, et al. . Health disparities between binary and non binary trans people: a community-driven survey. Int J Transgend 2019;20:218–29. 10.1080/15532739.2019.1629370
    1. Eyssel J, Koehler A, Dekker A, et al. . Needs and concerns of transgender individuals regarding interdisciplinary transgender healthcare: a non-clinical online survey. PLoS One 2017;12:e0183014. 10.1371/journal.pone.0183014
    1. Lykens JE, LeBlanc AJ, Bockting WO. Healthcare experiences among young adults who identify as genderqueer or nonbinary. LGBT Health 2018;5:191–6. 10.1089/lgbt.2017.0215
    1. Kreukels BPC, Haraldsen IR, De Cuypere G, et al. . A European network for the investigation of gender incongruence: the ENIGI initiative. Eur Psychiatry 2012;27:445–50. 10.1016/j.eurpsy.2010.04.009
    1. European Union agency for fundamental rights . LGBTI II: a long way to go for LGBTI equality. Luxembourg, 2020.
    1. Institute of Medicine of the National Academies . Quality through collaboration: the future of rural health. Washington, DC: National Academies Press, 2005.
    1. Selvaggi G, Giordano S. The role of mental health professionals in gender reassignment surgeries: unjust discrimination or responsible care? Aesthetic Plast Surg 2014;38:1177–83. 10.1007/s00266-014-0409-0
    1. Thornicroft G. Stigma and discrimination limit access to mental health care. Epidemiol Psichiatr Soc 2008;17:14–19. 10.1017/S1121189X00002621
    1. Reisner SL, Poteat T, Keatley J, et al. . Global health burden and needs of transgender populations: a review. Lancet 2016;388:412–36. 10.1016/S0140-6736(16)00684-X
    1. James SE, Herman JL, Rankin S. The report of the 2015 US. transgender survey. Washington, DC, 2017. Available:
    1. Safer JD, Coleman E, Feldman J, et al. . Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes 2016;23:168. 10.1097/MED.0000000000000227
    1. Loos FK, Köhler A, Eyssel J, et al. . Subjektive Indikatoren des Behandlungserfolges und Diskriminierungserfahrungen in der trans* Gesundheitsversorgung. Qualitative Ergebnisse einer Online-Befragung [Subjective indicators of treatment success and experiences of discrimination in interdisciplinary trans* healthcare: Qualitative results from an online survey]. Zeitschr Sexualforsch 2016;29:205–23. 10.1055/s-0042-114866
    1. Koehler A, Motmans J, Alvarez LM, et al. . How the COVID-19 pandemic affects transgender health care - A cross-sectional online survey in 63 upper-middle-income and high-income countries. Int J Transgend Health 2021:AHEAD-OF-PRINT:1–14. 10.1080/26895269.2021.1986191
    1. Fraser L. Etherapy: Ethical and Clinical Considerations for Version 7 of the World Professional Association for Transgender Health’s Standards of Care. Int J Transgend 2009;11:247–63. 10.1080/15532730903439492
    1. Horvath KJ, Iantaffi A, Swinburne-Romine R, et al. . A comparison of mental health, substance use, and sexual risk behaviors between rural and non-rural transgender persons. J Homosex 2014;61:1117–30. 10.1080/00918369.2014.872502
    1. Renner J, Blaszcyk W, Täuber L, et al. . Barriers to accessing health care in rural regions by transgender, non-binary, and gender diverse people: a case-based scoping review. Front Endocrinol 2021;12:717821. 10.3389/fendo.2021.717821
    1. Nieder TO, Koehler A, Briken P, et al. . Mapping key stakeholders' position towards interdisciplinary transgender healthcare: a stakeholder analysis. Health Soc Care Community 2020;28:385–95. 10.1111/hsc.12870
    1. Knutson D, Martyr MA, Mitchell TA, et al. . Recommendations from transgender healthcare consumers in rural areas. Transgend Health 2018;3:109–17. 10.1089/trgh.2017.0052
    1. Rosenkrantz DE, Black WW, Abreu RL, et al. . Health and health care of rural sexual and gender minorities: a systematic review. Stigma Health 2017;2:229–43. 10.1037/sah0000055
    1. LesMigraS . „…Nicht so greifbar und doch real“. Eine quantitative und qualitative Studie zu Gewalt- und (Mehrfach-) Diskriminierungserfahrungen von lesbischen, bisexuellen Frauen und Trans* in Deutschland. ["Not so tangible and yet real". A Quantitative and Qualitative Study on Experiences of Violence and (Multiple) Discrimination of Lesbian, Bisexual and Trans* Women in Germany]. LesMigraS, 2012. Berlin
    1. Fuchs W, Ghattas DC, Reinert D. Studie zur Lebenssituation von Transsexuellen in Nordrhein-Westfalen [Life of Transsexuals in North Rhine-Westphalia, Germany]. LSVD, 2012. Available:
    1. Sauer A, Meyer E. Wie ein grünes Schaf in einer weißen Herde. Lebenssituationen und Bedarfe von jungen Trans*-Menschen in Deutschland. [Like a green sheep in a white flock. Life situations and needs of young transgender people in Germany.], 2017. Available:
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Nieder TO, Strauss B. Transgender health care in Germany: participatory approaches and the development of a guideline. Int Rev Psychiatry 2015;27:416–26. 10.3109/09540261.2015.1074562
    1. Köhler A, Strauß B, Briken P. Interdisziplinär integriert oder dezentral verteilt? Versorgungssettings im Kontext feminisierender Genitaloperationen – Studienprotokoll zur Hamburger TransCare-Studie [Feminizing Genital Gender-affirmative Surgery in Centralized and Decentralized Health Care Settings - The Hamburg TransCare study]. Psychother Psychosom Med Psychol 2021;71:132–40. 10.1055/a-1243-0715
    1. Chapman R, Wardrop J, Freeman P, et al. . A descriptive study of the experiences of lesbian, gay and transgender parents accessing health services for their children. J Clin Nurs 2012;21:1128–35. 10.1111/j.1365-2702.2011.03939.x
    1. Chapman R, Watkins R, Zappia T, et al. . Second-level hospital health professionals' attitudes to lesbian, gay, bisexual and transgender parents seeking health for their children. J Clin Nurs 2012;21:880–7. 10.1111/j.1365-2702.2011.03938.x
    1. Loewy RL, Pearson R, Vinogradov S, et al. . Psychosis risk screening with the Prodromal Questionnaire--brief version (PQ-B). Schizophr Res 2011;129:42–6. 10.1016/j.schres.2011.03.029
    1. Beck AT. Beck depression inventory. San Antonio, TX: The Psychological Corporation, 1978.
    1. Posner K, Brown GK, Stanley B, et al. . The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168:1266–77. 10.1176/appi.ajp.2011.10111704
    1. Franke GH, Ankerhold A, Haase M. Der Einsatz des Brief Symptom Inventory 18 (BSI-18) bei Psychotherapiepatienten [The Usefulness of the Brief Symptom Inventory 18 (BSI-18) in Psychotherapeutic Patients]. Psychother Psych Med 2011;61:82–6. 10.1055/s-0030-1270518
    1. Franke GH, Jaeger S, Glaesmer H, et al. . Psychometric analysis of the brief symptom inventory 18 (BSI-18) in a representative German sample. BMC Med Res Methodol 2017;17:14. 10.1186/s12874-016-0283-3
    1. Zabora J, BrintzenhofeSzoc K, Jacobsen P, et al. . A new psychosocial screening instrument for use with cancer patients. Psychosomatics 2001;42:241–6. 10.1176/appi.psy.42.3.241
    1. Mustanski BS, Garofalo R, Emerson EM. Mental health disorders, psychological distress, and suicidality in a diverse sample of lesbian, gay, bisexual, and transgender youths. Am J Public Health 2010;100:2426–32. 10.2105/AJPH.2009.178319
    1. Smith NG, Ingram KM. Workplace heterosexism and adjustment among lesbian, gay, and bisexual individuals: the role of unsupportive social interactions. J Couns Psychol 2004;51:57–67.
    1. Kersting A, Dölemeyer R, Steinig J, et al. . Brief Internet-based intervention reduces posttraumatic stress and prolonged grief in parents after the loss of a child during pregnancy: a randomized controlled trial. Psychother Psychosom 2013;82:372–81. 10.1159/000348713
    1. Knaevelsrud C, Maercker A. Internet-based treatment for PTSD reduces distress and facilitates the development of a strong therapeutic alliance: a randomized controlled clinical trial. BMC Psychiatry 2007;7:13. 10.1186/1471-244X-7-13
    1. Schröder J, Jelinek L, Moritz S. A randomized controlled trial of a transdiagnostic Internet intervention for individuals with panic and phobias - One size fits all. J Behav Ther Exp Psychiatry 2017;54:17–24. 10.1016/j.jbtep.2016.05.002
    1. Wagner B, Knaevelsrud C, Maercker A. Internet-based cognitive-behavioral therapy for complicated grief: a randomized controlled trial. Death Stud 2006;30:429–53. 10.1080/07481180600614385
    1. Angermeyer MC, Kilian R, Matschinger H. WHOQOL - WHOQOL-100 und WHOQOL-BREF. Handbuch für die deutschsprachigen Versionen der WHO Instrumente zur Erfassung von Lebensqualität [Manual for the German-language versions of the WHO instruments for assessing quality of life]. Göttingen: Hogrefe Verlag, 2000.
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Schmidt J, Lamprecht F, Wittmann WW. Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments]. Psychother Psych Med 1989;39:248–55
    1. Chisholm D, Knapp MRJ, Knudsen HC, et al. . Client socio-demographic and service receipt inventory – European version: development of an instrument for international research. Br J Psychiatry 2000;177:s28–33. 10.1192/bjp.177.39.s28
    1. Raupach T, Schiekirka S, Münscher C, et al. . Piloting an outcome-based programme evaluation tool in undergraduate medical education. GMS Z Med Ausbild 2012;29:Doc44 10.3205/zma000814
    1. Jakobsen JC, Gluud C, Wetterslev J, et al. . When and how should multiple imputation be used for handling missing data in randomised clinical trials – a practical guide with flowcharts. BMC Med Res Methodol 2017;17:1–10. 10.1186/s12874-017-0442-1
    1. Schulz KF, Altman DG, CONSORT MD. Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;2010:698–702.
    1. Roick C, Kilian R, Matschinger H, et al. . Die deutsche Version des Client Sociodemographic and Service Receipt Inventory - Ein Instrument zur Erfassung psychiatrischer Versorgungskosten [German adaptation of the Client Sociodemographic and Service Receipt Inventory - an instrument for the cost of mental health care]. Psychiatr Prax 2001;28:84–90. 10.1055/s-2001-17790
    1. Ludwig K, Graf von der Schulenburg J-M, Greiner W. German value set for the EQ-5D-5L. Pharmacoeconomics 2018;36:663–74. 10.1007/s40273-018-0615-8
    1. Drummond MF, Sculpher MJ, Claxton K. Methods for the economic evaluation of health care programmes. 4th ed. Oxford: Oxford University Press, 2015.
    1. Hoch JS, Briggs AH, Willan AR. Something old, something new, something borrowed, something blue: a framework for the marriage of health econometrics and cost-effectiveness analysis. Health Econ 2002;11:415–30. 10.1002/hec.678
    1. Wang Y, Pan B, Liu Y, et al. . Health care and mental health challenges for transgender individuals during the COVID-19 pandemic. Lancet Diabetes Endocrinol 2020;8:564–5. 10.1016/S2213-8587(20)30182-0
    1. Eysenbach G. What is e-health? J Med Internet Res 2001;3:1–5.
    1. Andersson G. Internet interventions: past, present and future. Internet Interv 2018;12:181–8. 10.1016/j.invent.2018.03.008
    1. Magnus M, Edwards E, Dright A, et al. . A feasibility study of a telehealth intervention on health care service utilization among transgender women of color in Washington, DC. ACI open 2018;02:e1–9. 10.1055/s-0038-1639603
    1. White Hughto JM, Reisner SL, Pachankis JE. Transgender stigma and health: a critical review of stigma determinants, mechanisms, and interventions. Soc Sci Med 2015;147:222–31. 10.1016/j.socscimed.2015.11.010
    1. White Hughto JM, Murchison GR, Clark K, et al. . Geographic and individual differences in healthcare access for U.S. transgender adults: a multilevel analysis. LGBT Health 2016;3:424–33. 10.1089/lgbt.2016.0044
    1. Bockting WO, Miner MH, Swinburne Romine RE, et al. . Stigma, mental health, and resilience in an online sample of the US transgender population. Am J Public Health 2013;103:943–51. 10.2105/AJPH.2013.301241
    1. Whitehead J, Shaver J, Stephenson R. Outness, stigma, and primary health care utilization among rural LGBT populations. PLoS One 2016;11:e0146139. 10.1371/journal.pone.0146139

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться