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Evaluating the feasibility, acceptability, and preliminary efficacy of a peer support program for trans people on a waitlist to access gender affirming care (‘Thriving Transitions’): a randomised controlled trial

Randomised controlled trial evaluation of the feasibility, acceptability, and preliminary efficacy of a peer support program for reducing suicidality, depressive symptoms, and improving quality of life among trans people on a waitlist to access gender affirming care relative to standard care (‘Thriving Transitions’)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000654459
Enrollment
40
Registered
2025-06-20
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will conduct a randomised controlled trial to evaluate the feasibility, acceptability, and preliminary efficacy of the program to reduce suicidality, depressive symptoms, and improve quality of life, among trans people on a waitlist for initiating GAHT. Participants in the intervention condition will attend 7 x 1.5hr weekly sessions of the peer support program over seven weeks, co-facilitated by two trans people. Participants in the control group will remain on the standard care waitlist and will not receive the intervention. Participants in both groups will be required to complete 3 x 20min online health surveys. If proven feasible, acceptable, with preliminary evidence of efficacy, this program may represent an implementation-ready and readily scalable solution to address the mental health support needs of trans people on GAHT waitlists across Australia.

Interventions

This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of an online peer support program (‘Thriving Transitions’) for reducing suicidal ideation, depressive symptoms, and improving quality of life, among trans people on a waitlist for initiating gender affirming hormone therapy, compared to standard care as usual. Participants will be allocated to intervention (‘Thriving Transitions’) or standard care (no intervention). Intervention is a peer support program consi

This study aims to evaluate the feasibility, acceptability, and preliminary efficacy of an online peer support program (‘Thriving Transitions’) for reducing suicidal ideation, depressive symptoms, and improving quality of life, among trans people on a waitlist for initiating gender affirming hormone therapy, compared to standard care as usual. Participants will be allocated to intervention (‘Thriving Transitions’) or standard care (no intervention). Intervention is a peer support program consisting of 7 x 1.5 hr once weekly sessions over a 7 week period. This will be delivered online via videoconference by two peer facilitators (both trained in providing support to trans people experiencing suicidal thoughts. The peer support program will cover the following topics: 1. Introductions, group agreement 2. Medical gender affirmation 3. Hoping and coping 4. Coming out or ‘inviting in’ 5. Sex, dating, and intimacy 6. Gender embodiment goals 7. Trans futures Facilitators will be provided with a comprehensive facilitator training and delivery manual which outlines key details about the background and co-development of the Thriving Transitions intervention, in addition to week-by-week aims, learning objectives, key topics to be discussed and explored, and relevant local resources and services as they pertain to the topic. Additionally, this document outlines the schedule of activities (including discussion activities) to be facilitated for each week, including prompts, follow-up questions, implementation considerations to be planned and anticipated. All facilitators will receive a half-day (~4hr equivalent) of training at least 4 weeks prior to the program commencement date delivered by 1-2 independent member(s) of the research team. Training day will involve orientation, introductions and fostering collegiality and familiaritiy, going through content, asking questions, with optional practical (e.g., role-play) activities for targeted training about specific scenarios or anticipated concerns of facilitators. Each week, co-facilitators with debrief together. Facilitators will also have access to a weekly supervision session provided a trans peer. To monitor adherence and fidelity, facilitators will be required to complete weekly implementation and debrief logbooks within which attendance will be annotated. Within 48 hours following a session, facilitators will send a ‘wrap-up’ style email summarising the previous week and, additionally, an ‘orientation’ style email will send at least 48 hours in advance an ‘orientation’ style email providing an overview of the upcoming session, including notices and reminders of attendance. This logbook will also allow facilitators to reflexively denote any facilitators and barriers to participant engagement and participation among attendees from that week. From participant enrolment stage, to be eligible for this study participants must be able to confirm that they do not foresee any difficulty to regularly attending the 7-week Thriving Transitions program in the event that they are randomly allocated to receive the program.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. have a gender different to the one presumed for them at birth (often termed ‘trans’) 2. aged 18+ years at time of study, and 3. seeking initiation of gender affirming hormone therapy (GAHT) at Austin Health Gender Clinic or North-Eastern Urology

Exclusion criteria

1. has the same gender that was presumed for them at birth (often termed ‘cisgender’) 2. Aged <18 years 3. people who have ever undertaken a regime of GAHT 4. people seeking to re-initiate GAHT (or who have taken GAHT previously) 5. people who foresee difficulty to regularly attend seven weekly sessions of a trans peer support group program and complete health and evaluation surveys over a three month period 6. people who are experiencing mental ill-health difficulties which may make them unable to take care of themselves and keep themselves safe throughout the study duration 7. people who feel that their level of English language proficiency may negatively impact their ability to participate and experience an English language-run trans peer support group program run across six fortnightly sessions over three months

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026