i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

NCT04290286 | Completed DMC

• 1 other identifier: i2TransHealth
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief 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 \[people with transsexualism (TS: ICD-10), gender incongruence (GIC: ICD-11) and/or gender dysphoria (GD: DSM-5)\] 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. 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.

Conditions

Gender Dysphoria; Gender Identity Disorder; Transsexualism; Gender Identity; Gender Incongruence

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

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

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

• Treatment satisfaction according to modified version ZUF-8

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

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

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

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

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

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

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

Study Arms (2)

intervention group

EXPERIMENTAL

TGD people (n = 82) receive 4 months of e-health intervention according to the i2TransHealth model of care (intervention group)

Other: i2TransHealth

waiting group

NO INTERVENTION

TGD people (n = 82) wait 4 months until they are offered regular care (waiting group), which can include video consultation

Interventions

i2TransHealth OTHER

i2TransHealth: online intervention for TGD people

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (4)

• 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. doi: 10.1186/s12913-026-14026-y. Online ahead of print.

  PMID: 41580775 DERIVED

• 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.

  PMID: 40204312 DERIVED

• 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.

  PMID: 39419729 DERIVED

• 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.

  PMID: 35105559 DERIVED

Related Links

• https://www.i2transhealth.de/english-landing-page/

MeSH Terms

Conditions

Gender Dysphoria; Transsexualism

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, Psychological; Mental Disorders; Sexuality; Sexual Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI: Timo Nieder, PhD ECPS, Head of Outpatient Unit for Sexual Health and Transgender Care, Institute for Sex Research, Sexual Medicine and Forensic Psychiatry (Co-PI: Arne Dekker, PhD, Peer Briken, MD FECSM Prof))

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: February 28, 2020
• Study Start: May 1, 2020
• Primary Completion: May 31, 2022
• Study Completion: September 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)