i2TransHealth: Interdisciplinary, Internet-based Trans Health Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Gender Dysphoria Gender Identity Disorder Transsexualism Gender Identity Gender Incongruence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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intervention group

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

Group Type EXPERIMENTAL

i2TransHealth

Intervention Type OTHER

i2TransHealth: online intervention for TGD people

waiting group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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i2TransHealth

i2TransHealth: online intervention for TGD people

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Timo Nieder

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))

Responsibility Role PRINCIPAL_INVESTIGATOR