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Gender DysphoriaNCT04290286

i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

A study testing i2TransHealth in people with Gender Dysphoria and Gender Identity Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

i2TransHealth is a randomized controlled trial that investigates the outcomes of an internet-based health care approach for transgender and gender diverse (TGD) people. As a health services research project, i2TransHealth aims at reducing the structural disadvantage for TGD people [people with transsexualism (TS… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
i2TransHealth
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
1 siteGermany
Study dates
1 May 2020to 30 Sep 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older
  • Gender different from their assigned sex at birth
  • resident at least 50 km outside Hamburg
  • present themselves with treatment needs (TS/GD) to one of the participating physicians in the i2TransHealth network, or direct contact with institute and/or e-health platform
  • receive the suspected diagnosis TS/GD during an initial interview in the UKE
  • can operate the video chat cognitively, verbally and auditory
  • Able to read, speak, and understand German
  • Written informed consent after written and oral information

Who cannot join

  • Under 18 years of age
  • Missing informed consent
  • Unable to speak German
  • Indication for inpatient treatment, e.g. due to acute psychotic symptoms (self-report, Prodromal Questionnaire, PQ-B) or severe depressive symptoms (self-report, BDI-II ≥ 29)
  • Acute suicidal tendencies
  • Decrease in intelligence (IQ below 70)
  • Acute drug intoxication
  • Failure to meet technical requirements (no Internet access, lack of IT knowledge)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246

Other trials in Germany

About this study

Official title: Interdisciplinary, Internet-based Trans Health Care (i2TransHealth): A Randomized Controlled Trial

i2TransHealth is a randomized controlled trial that investigates the outcomes of an internet-based health care approach for transgender and gender diverse (TGD) people. As a health services research project, i2TransHealth aims at reducing the structural disadvantage for TGD people [people with transsexualism (TS: ICD-10), gender incongruence (GIC: ICD-11) and/or gender dysphoria (GD: DSM-5)] living in areas lacking specialized transition-related treatment.

Located at the Institute for Sex Research and in cooperation with the Interdisciplinary Transgender Health Care Center Hamburg (ITHCCH), both University Medical Center Hamburg-Eppendorf (UKE), i2TransHealth is an innovative intervention including video consultation and a 1:1 chat with clinical psychologists. By cooperating with the ITHCCH, general physicians and psychiatrists provide first and local access to the specialized treatment provided by the UKE.

Read more

In the intervention group, the study participants are invited to use the i2TransHealth e-health platform including a video consultation hour every two weeks and a messenger between the video-meetings. In addition, they have the opportunity to receive medical support close to their home by licensed GPs and psychiatrists according to their needs (especially in case of a somatic or mental health crisis). The waiting group participants will be able to go forward with transition-related care after four months of study participation, as part of regular care.

The primary outcome measure is a reduced symptomatology for TGD people (BSCL). Secondary outcome parameters include quality of life and patient satisfaction as well as healthcare-related costs and cost-effectiveness. Finally, based on a longitudinal design, it will be assessed if the physicians improve their TGD-related expertise by cooperating within the i2TransHealth-network.

Being tested
i2TransHealth
Medical subject headings
Gender Dysphoria, Transsexualism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • i2TransHealthOther

    i2TransHealth: online intervention for TGD people

Study groups in NCT04290286
Study groupRoleWhat they receive
intervention groupExperimentalTGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)
Receives: Other: i2TransHealth
waiting groupNo interventionTGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Symptom burden according to BSI-18

    References:

    Franke, G. H. (2000). Franke, G.H. (2000). BSI. Brief Symptom Inventory - Deutsche Version. Manual. Göttingen: Beltz.

    Measured: Change from Baseline Mental Health Symptoms to the point of time after online intervention (Baseline + 4 months)

Secondary outcomes (6)

  1. Quality of Life (physical health, psychological health, social relationships, and environment)

    QoL is measured using the WHOQOL-BREF (WHO, 1998).

    References:

    Angermeyer, M. C., Kilian, R., \& Matschinger, H. (2000). WHOQOL - WHOQOL-100 und WHOQOL-BREF. Handbuch für die deutschsprachigen Versionen der WHO Instrumente zur Erfassung von Lebensqualität.

    WHO (1998). Development of the World Health Organization WHOQOL-BREF quality of life assessment. Psychological medicine, 28(3), 551-558.

    Measured: Change from Baseline QoL to the point of time after online intervention (Baseline + 4 months)]

  2. Treatment satisfaction according to modified version ZUF-8

    References:

    Schmidt, J., Lamprecht, F., \& Wittmann, W. W. (1989). Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments.]. PPmP: Psychotherapie Psychosomatik Medizinische Psychologie, 39(7), 248-255.

    Measured: Treatment satisfaction at the point of time after online intervention (4 months after admission to studies)

  3. Direct or indirect costs and productivity losses by persons with TS/GD in comparison to the German general population (via CSSRI)

    References:

    Chisholm, D., Knapp, M. R. J., Knudsen, H. C., Amaddeo, F., Gaite, L., Wijngaarden, B. van, \& Group, E. S. (2000). Client Socio-Demographic and Service Receipt Inventory - European Version: Development of an instrument for international research: EPSILON Study 5. The British Journal of Psychiatry, 177(S39), s28-s33. https://doi.org/10.1192/bjp.177.39.s28

    Measured: Change from Baseline to the point of time after online intervention (Baseline + 4 months)

  4. Health-related quality of life (via EQ-5D-5L): quality-adjusted life years (QALYs)

    References:

    Herdman, M., Gudex, C., Lloyd, A., Janssen, MF., Kind, P., Parkin, D., … Badia, X. (2011). Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Quality of Life Research, 20(10), 1727-1736. https://doi.org/10.1007/s11136-011-9903-x

    Measured: Change from Baseline to the point of time after online intervention (Baseline + 4 months)

  5. Knowledge increase of the cooperating physicians on trans health care (via VSE)

    References:

    Raupach, T., Schiekirka, S., Münscher, C., Beißbarth, T., Himmel, W., Burckhardt, G., \& Pukrop, T. (2012). Implementierung und Erprobung eines Lernziel-basierten Evaluationssystems im Studium der Humanmedizin. GMS Zeitschrift für medizinische Ausbildung, 29(3), 1-14.

    Measured: Change from Baseline to the point of time after study completion (Baseline + 18 months)

  6. Satisfaction of the cooperating physicians with the support in the i2TransHealth network (via modified version ZUF-8)

    References:

    Schmidt, J., Lamprecht, F., \& Wittmann, W. W. (1989). Zufriedenheit mit der stationären Versorgung. Entwicklung eines Fragebogens und erste Validitätsuntersuchungen. [Satisfaction with inpatient care: Development of a questionnaire and first validity assessments.]. PPmP: Psychotherapie Psychosomatik Medizinische Psychologie, 39(7), 248-255.

    Measured: Satisfaction at the point of time after study completion (18 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start1 May 2020
  3. Primary completion31 May 2022
  4. Study completion30 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290286
Sponsor's protocol ID
i2TransHealth
Status last verified
Nov 2022
First submitted
26 Feb 2020
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Renner J, Briken P, Dekker A, Pregartbauer L, Zapf A, Sehner S, Pepic A, Augustin M, Nieder TO. Which transgender and gender diverse groups benefit most from E-health? Subgroup analyses of the randomized controlled trial i2TransHealth in Germany. Int J Transgend Health. 2025 Feb 22;27(2):824-839. doi: 10.1080/15532739.2025.2465710. eCollection 2026.

    PubMed 41891088

  • Schmidt F, Renner J, Schroder SI, Pregartbauer L, Dekker A, Nieder TO. Enabling and hindering aspects of the i(2)TransHealth e-health intervention for transgender and gender diverse people in Germany: a qualitative process evaluation. BMC Health Serv Res. 2026 Jan 24;26(1):149. doi: 10.1186/s12913-026-14026-y.

    PubMed 41580775

  • Grochtdreis T, Konig HH, Renner J, Sehner S, Dekker A, Briken P, Nieder TO, Dams J. Cost-Effectiveness of an Interdisciplinary, Internet-Based Transgender Health Care Program in Germany: Economic Evaluation Alongside a Randomized Controlled Trial. J Med Internet Res. 2025 Jun 19;27:e66371. doi: 10.2196/66371.

    PubMed 40537093

  • Grochtdreis T, Konnopka A, Renner J, Konig HH, Dekker A, Briken P, Nieder T, Dams J. Excess costs of transgender and gender-diverse people with gender incongruence and gender dysphoria compared with people from the general population in Germany: a secondary analysis using data from a randomised controlled trial and a representative telephone survey. BMJ Open. 2025 Apr 9;15(4):e089663. doi: 10.1136/bmjopen-2024-089663.

    PubMed 40204312

  • Nieder TO, Renner J, Sehner S, Pepic A, Zapf A, Lambert M, Briken P, Dekker A. Effect of the i2TransHealth e-health intervention on psychological distress among transgender and gender diverse adults from remote areas in Germany: a randomised controlled trial. Lancet Digit Health. 2024 Dec;6(12):e883-e893. doi: 10.1016/S2589-7500(24)00192-4. Epub 2024 Oct 16.

    PubMed 39419729

  • Nieder TO, Renner J, Zapf A, Sehner S, Hot A, Konig HH, Dams J, Grochtdreis T, Briken P, Dekker A. Interdisciplinary, internet-based trans health care (i(2)TransHealth): study protocol for a randomised controlled trial. BMJ Open. 2022 Feb 1;12(2):e045980. doi: 10.1136/bmjopen-2020-045980.

    PubMed 35105559

Questions about this trial

What is this clinical trial studying?

A study testing i2TransHealth in people with Gender Dysphoria and Gender Identity Disorder, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom burden according to BSI-18 (time frame: Change from Baseline Mental Health Symptoms to the point of time after online intervention (Baseline + 4 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290286, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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