NCT05693324

Brief Summary

The aim of this project is to get a better understanding of transgender and gender non-conforming (TGNC) people's experiences of minority joy and minority stress over time. Further, the project explores how these experiences covary with psychiatric and physical ill health and quality of life before, during and after a TGNC affirmative intervention in adult and adolescent participants over 15 years of age. The intervention consists of three parts, given in randomized order: 1. Psychoeducation and behavioral interventions about external minority stress, 2. Cognitive interventions targeting worry, and 3. Self-compassion aiming to relieve internalized transphobia. This project uses a mixed methods data collection consisting of interviews as well as a replicated single case design (SCED). More detailed pre- and post measurements will also be collected. The interviews enable us to explore minority joy in detail, as well as getting feedback about the feasibility and acceptability of the intervention. The SCED enables us to visualize the interplay between everyday experiences and health, while testing the affirmative program. The project will provide much needed knowledge, which in turn will improve health in TGNC people.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

January 10, 2023

Last Update Submit

January 24, 2023

Conditions

Keywords

transpeopleminority joyminority stress

Outcome Measures

Primary Outcomes (1)

  • Weekly measurement, specifically constructed for this study

    Assesses minority stress/joy, self-compassion, worry, pain, depression, anxiety, and quality of life with two questions each, resulting in 16 short questions, answerable between 1-10. For self-compassion, minority joy and quality of life, higher scores indicate better functioning, for depression, minority stress, anxiety, pain, worry, higher scores indicate more problems. Additionally, experiences can be described in a free text.

    20-24 weeks

Secondary Outcomes (6)

  • Self compassion scale

    pre- and post measurement with 20-24 weeks between measurements, collected at the start of baseline and just after the last intervention module

  • Penn State Worry questionnaire

    pre- and post measurement with 20-24 weeks between measurements, collected at the start of baseline and just after the last intervention module

  • Pain grades

    pre- and post measurement with 20-24 weeks between measurements, collected at the start of baseline and just after the last intervention module

  • Depression Anxiety Stress Scale, DASS

    pre- and post measurement with 20-24 weeks between measurements, collected at the start of baseline and just after the last intervention module

  • quality of life, SWLS

    pre- and post measurement with 20-24 weeks between measurements, collected at the start of baseline and just after the last intervention module

  • +1 more secondary outcomes

Study Arms (6)

1 Minority stress

ACTIVE COMPARATOR

Intervention starts with the minority stress module, followed by worry and then compassion. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

2 Minority stress

ACTIVE COMPARATOR

Intervention starts with minority stress module, followed by compassion and then worry. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

3 Worry

ACTIVE COMPARATOR

Intervention starts with worry module, followed by minority stress and then compassion. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

4 Worry

ACTIVE COMPARATOR

Intervention starts with worry module, followed by compassion and then minority stress. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

5 Compassion

ACTIVE COMPARATOR

Intervention starts with compassion module, followed by minority stress and then worry. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

6 Compassion

ACTIVE COMPARATOR

Intervention starts with compassion, followed by worry and then minority stress. Modules are given with a trans-affirmative stance, based on the minority stress model. The minority stress module contains psychoeducation on minority stress and minority joy as well as behavioral interventions. The worry module contains cognitive interventions. The compassion module targets internalized transphobia and is based on compassion-focused therapy.

Behavioral: Minority stress

Interventions

Minority stressBEHAVIORAL

Intervention based on Cognitive Behavioural and Compassion Focused Treatments

Also known as: Worry, Compassion
1 Minority stress2 Minority stress3 Worry4 Worry5 Compassion6 Compassion

Eligibility Criteria

Age15 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsA gender identity different from assigned sex at birth
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Identity other than assigned sex at birth
  • Access to internet and ability to fill in questionnaires in Swedish

You may not qualify if:

  • Ongoing psychiatric or other problems that make it unlikely that intervention schedule can be followed (e.g. acute problems requiring other care, inability to schedule sessions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University

Örebro, 70381, Sweden

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Matilda Wurm, PhD

    Örebro University, Sweden

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matilda Wurm, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study employs a single-case experimental design with randomized waiting period lengths (4, or 6 weeks) as well as randomization to three treatment arms (same content, different progress through the three modules). Included in the design is also standardized pre- and post measurement allowing for single group analysis of change. In addition, we collect qualitative data from participants, detailing how the intervention is experienced.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 10, 2023

First Posted

January 23, 2023

Study Start

December 1, 2022

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Data will not be shared freely, but will be saved on the university server. Access can be requested by contacting PI or data manager at the university.

Locations