Early-onset trans-sensitive therapy as part of gender dysphoria care
ISRCTN | ISRCTN55280200 |
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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
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
Scientific
Helsinki University Hospital
PB 250
Helsinki
00029HUS
Finland
Phone | +358 504270354 |
---|---|
katinka.tuisku@hus.fi |
Scientific
Helsinki University Hospital
PB 250
Helsinki
00029HUS
Finland
Phone | +358 405440554 |
---|---|
niina.m.puustinen@hus.fi |
Study information
Study design | Randomized controlled trial within a naturalistic cohort |
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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 |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
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
00029 HUS
Finland
Sponsor information
Hospital/treatment centre
PB250
Helsinki
00029HUS
Finland
Phone | +358 94711 |
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HUSdg_1109003@hus.fi | |
Website | https://www.hus.fi/en |
https://ror.org/02e8hzf44 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Helsinki University Central Hospital, HUS
- Location
- Finland
Results and Publications
Intention to publish date | 31/12/2027 |
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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.