Early-onset trans-sensitive therapy as part of gender dysphoria care

ISRCTN	ISRCTN55280200
DOI	https://doi.org/10.1186/ISRCTN55280200
EudraCT/CTIS number	Nil Known
ClinicalTrials.gov number	Nil Known

Submission date: 14/04/2021
Registration date: 09/10/2025
Last edited: 09/10/2025

Recruitment status: No longer recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Psychosocial support can be provided at an early stage of gender-identity assessment and gender gender-affirming treatment process. The aim is to assess the effects of an early-onset trans-sensitive psychotherapy on the well-being of individuals seeking gender-affirming treatment.

Who can participate?
Study participants are non-treated patients referred to the Outpatient clinic for Assessment of Gender identity during the autumn of 2020.

What does the study involve?
In this pilot RCT study, an early-onset trans-sensitive therapy is integrated into gender dysphoria care. A naturalistic clinical sample of 60 consecutive individuals seeking gender affirming treatment is randomly allocated into two groups: one group received early therapy, while the other underwent the standard assessment process. The primary outcome investigates general health, and the secondary outcome looks at mental well-being, both using validated scales.

What are the possible benefits and risks of participating?
The possible benefits can be better coping with stress, increased wellbeing and readiness for self-reflection during the assessment process. Possible risks can be investment of time with no benefits, and the insufficiency of time-limited therapeutic intervention, if there are psychiatric disorders or psychosocial problems that would require other types of interventions.

Where is the study run from?
Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
May 2020 to December 2026

Who is funding the study?
Helsinki University Hospital (Finland)

Who is the main contact?
Dr Katinka Tuisku, katinka.tuisku@hus.fi
Dr Niina Puustinen, niina.m.puustinen@hus.fi

Contact information

Dr Katinka Tuisku
Scientific

Helsinki University Hospital
PB 250
Helsinki
00029HUS
Finland

Phone	+358 504270354
Email	katinka.tuisku@hus.fi

Dr Niina Puustinen
Scientific

Helsinki University Hospital
PB 250
Helsinki
00029HUS
Finland

Phone	+358 405440554
Email	niina.m.puustinen@hus.fi

Study information

Study design	Randomized controlled trial within a naturalistic cohort
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a participant information sheet (languages: Finnish and Swedish)
Scientific title	The changing diagnostics and the clinical picture of gender dysphoria: Evaluation and effectiveness of the treatments
Study acronym	GDDGTREAT32
Study objectives	The early timing of a short trans sensitive psychotherapeutic intervention, before diagnostic and gender reassignment procedures will be better than the same intervention later in the process (treatment as usual)
Ethics approval(s)	Approved 06/05/2020, Helsinki and Uusimaa Hospital District Ethics Committee II (Keskuskirjaamo PL 200, Marjaniementie 74, Iiris-Keskus, Helsinki, 00029 HUS, Finland; +358 40359 4618 ; eettinen.toimikunta@hus.fi), ref: HUS/2924/2018
Health condition(s) or problem(s) studied	Gender dysphoria
Intervention	An early intervention-subsample of a naturalistic gender dysphoria cohort. Patients referred for diagnostics and treatment of Gender dysphoria at the University Hospital outpatient clinic are randomized to two groups: An early waiting list-intervention and treatment as usual ( the same intervention later in the clinical process) Participants are randomized 1:1 to receive either 10 sessions of individual early onset trans-sensitive therapy or the standard evaluation protocol. The aim is to offer the early intervention to the participants while queuing for the assessment. The randomization is conducted with the sealed envelope method.
Intervention type	Behavioural
Primary outcome measure	General health measured using the Finnish version of the General Health Questionnaire (GHQ) at baseline and approximately 6 months after. Exact dates in a naturalistic clinical study.
Secondary outcome measures	Mental well being measured using the Short Warwick-Edinburgh Mental Well-being Scale, before and after the early psychotherapeutic waiting-list intervention, and at the endpoint of the assessment procedure
Overall study start date	06/05/2020
Completion date	31/12/2026

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target number of participants	60
Key inclusion criteria	1. Non-treated patients referred to outpatient clinic for assessment of gender identity 2. Aged 18 years or above
Key exclusion criteria	An ongoing gender reassignment treatment, or only a consultative assessment
Date of first enrolment	01/08/2020
Date of final enrolment	31/12/2021

Locations

Countries of recruitment

Finland

Study participating centre

Helsinki University Hospital

PB 250
Helsinki
00029 HUS
Finland

Sponsor information

Helsinki University Hospital
Hospital/treatment centre

PB250
Helsinki
00029HUS
Finland

Phone	+358 94711
Email	HUSdg_1109003@hus.fi
Website	https://www.hus.fi/en
"ROR"	https://ror.org/02e8hzf44

Funders

Funder type

Hospital/treatment centre

Helsingin ja Uudenmaan Sairaanhoitopiiri
Government organisation / Local government

Alternative name(s): Helsinki University Central Hospital, HUS
Location: Finland

Results and Publications

Intention to publish date	31/12/2027
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a peer-reviewed journal
IPD sharing plan	The datasets generated during the current study are not expected to be made available due to privacy and data protection. The sample is a small, naturalistic clinical sample, and the data are derived from patient files.

Editorial Notes

14/08/2025: Study's existence confirmed by the Helsinki and Uusimaa Hospital District Ethics Committee II.