NCT07809529

Brief Summary

This proposed pilot study aims to evaluate the "EmbraceMe", a self-compassion intervention to improve positive body image and mental health among transgender and gender-diverse (TGD) people in Hong Kong.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Nov 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

August 28, 2026

Last Update Submit

September 2, 2026

Conditions

Self-Compassion

Keywords

transgender and gender-diverse peoplestigmaself-compassionbody imagemental health

Outcome Measures

Primary Outcomes (1)

  • Feasibility outcomes

    Completion rate: In each group, the completion rate is defined as the number of participants who complete outcome measurements at immediate post-intervention and 3-month follow-up divided by those who are randomized.

    Baseline; immediately after the intervention; 3-month post-intervention.

Secondary Outcomes (7)

  • Acceptability

    Immediately after the intervention

  • Self-compassion

    Baseline; immediately after the intervention; 3-month post-intervention.

  • Internalized stigma

    Baseline; immediately after the intervention; 3-month post-intervention.

  • Self-esteem

    Baseline; immediately after the intervention; 3-month post-intervention.

  • Body appreciation

    Baseline; immediately after the intervention; 3-month post-intervention.

  • +2 more secondary outcomes

Study Arms (2)

"EmbraceMe" intervention group

EXPERIMENTAL

Participants in the "EmbraceMe" intervention group will receive group-based self-compassion intervention comprising five consecutive weekly sessions, with each session lasting 2 hours (totaling 10 hours).

Other: "Embraceme" self-compassion intervention

Waiting-list control group

NO INTERVENTION

Participants in the waiting-list control group will receive the "EmbraceMe" intervention after thecompletion of the intervention at a 3-month follow-up.

Interventions

"Embraceme" self-compassion interventionOTHER

Participants in the "EmbraceMe" intervention group will receive group-based self-compassion intervention comprising five consecutive weekly sessions, with each session lasting 2 hours (totaling 10 hours). Each session will include an introduction, guided exercises, group discussions and home practice.

"EmbraceMe" intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years or above;
  • self-identified as a transgender and gender-diverse (TGD) individual;
  • sufficient comprehension of Cantonese;
  • currently livein Hong Kong;
  • able to provide informed consent.

You may not qualify if:

  • currently experiencing psychosis;
  • having an intellectual disability;
  • experiencing current suicidal ideation (score ≥ 4) as measured using the Columbiasuicide severity rating scale
  • currently enrolled in or have previously received similarservices or interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing and Health Sciences, Hong Kong Metropolitan University

Hong Kong, 999077, Hong Kong

Location

MeSH Terms

Conditions

Social StigmaPsychological Well-Being

Condition Hierarchy (Ancestors)

Social BehaviorBehaviorPersonal Satisfaction

Study Officials

  • Haixia MA, PhD

    School of Nursing and Health Sciences, Hong Kong Metropolitan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haixia MA, PhD

CONTACT

(852) 3970-2990phxma@hkmu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants in the "EmbraceMe" intervention group will receive group-based self-compassion intervention comprising five consecutive weekly sessions, with each session lasting 2 hours (totaling 10 hours).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 9, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

April 30, 2028

Study Completion (Estimated)

April 30, 2028

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Due to the sensitive nature of the participant population (transgender and gender-diverse individuals), we will only share the individual participant data (IPD) that directly underpin the results presented in the publication.

Locations

HK(1)