Condition category
Mental and Behavioural Disorders
Date applied
04/12/2019
Date assigned
12/02/2020
Last edited
21/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Evidence suggests that mental health outcomes are generally worse for LGBTQIA+ people than the rest of the population. They experience higher rates of mental illness, suicide, self- harm, eating disorders and substance misuse, which may arise from events like family rejection and sexual abuse. LGBTQIA+ people have been found to be more likely to face mental health issues such as depression and anxiety. People who identify as LGBTQIA+ in the UK also report a lower quality of life than the general population.

Promising approaches to helping LGBTQIA+ individuals struggling with mixed mental health conditions are mindfulness, mindful self-compassion (MSC) and compassion-focused therapy (CFT). This study has drawn on some essential content from these methodologies into one accessible intervention that supports wellbeing and self-acceptance for LGBTQIA+ populations.

The primary research question of this study is to determine whether a tailored group-based intervention, grounded in existing mindfulness, MSC and CFT approaches, can improve wellbeing and mental health outcomes of LGBTQIA+ individuals.

Who can participate?
Self-identified LGBTQIA+ individuals aged 18 years or older.

What does the study involve?
Participants will be randomly assigned to receive the intervention or not. The intervention is a 8-week course of group sessions.

What are the possible benefits and risks of participating?
The 8-week Radical Self-care course is not group therapy but a low-intensity training programme. The possible benefits include improvement in mental health and well-being of the study participants (members of the LGBTQIA+ community), specifically issues centred around shame, anxiety and depression. The potential risks resulting from the training sessions are deemed minimal. Participants are not being asked nor encouraged to disclose emotional, psychological, health, or education-related issues during the course. However, given the introspective nature of the course, some participants may experience psychological discomfort. Some amount of psychological discomfort is anticipated and built into the structure of the course: Skills geared toward dealing with anticipated psychological discomfort include dealing with “backdraft” (emotional, mental, or physical uneasiness that arises from engaging with the self-compassion practice) and “disillusionment” (when participants feel they are “failing” at self-compassion and how to move past that hurdle). Course skills are graded and scaled up as participants gain confidence and competency with their practice. It is possible that some participants might move beyond this anticipated psychological discomfort to experiencing emotional distress during the course. This could occur if their mental health status or support systems change during the progression of the course. All course practitioners are trained to recognise signs and signals that a participant may be suffering emotional harm, and would refer these participants to receive appropriate support.

Where is the study run from?
1. City, University of London, UK
2. Mind in the City, Hackney, and Waltham Forrest, UK
3. Mind in Salford, UK
4. LGBT Foundation, UK

When is the study starting and how long is it expected to run for?
From June 2019 to December 2020

Who is funding the study?
Government Equalities Office, UK

Who is the main contact?
1. Lucie Zernerova (Scientific), Lucie.Zernerova.1@city.ac.uk
2. Dr Paul Flaxman (Scientific), Paul.Flaxman.1@city.ac.uk
3. Dr Andreas Kappes (Scientific), andreas.kappes@city.ac.uk
4. Stephanie Cerce (Scientific), stephanie@mindinsalford.org.uk
5. Markus Greenwood (Public), markus@mindinsalford.org.uk
6. Miia Chambers (Public), Miia.Chambers@mindchwf.org.uk

Trial website

https://rainbowmind.org/radical-self-care/

Contact information

Type

Scientific

Primary contact

Mrs Lucie Zernerova

ORCID ID

http://orcid.org/0000-0003-0099-4335

Contact details

City
University of London
Northampton Square
London
EC1V 0HB
United Kingdom
+44 (0)20 7040 5060
Lucie.Zernerova.1@city.ac.uk

Type

Scientific

Additional contact

Dr Paul Flaxman

ORCID ID

http://orcid.org/0000-0002-6417-2499

Contact details

City
University of London
Northampton Square
London
EC1V 0HB
United Kingdom
+44 (0)20 7040 8484
Paul.Flaxman.1@city.ac.uk

Type

Scientific

Additional contact

Dr Andreas Kappes

ORCID ID

http://orcid.org/0000-0003-0867-6630

Contact details

City
University of London
Northampton Square
London
EC1V 0HB
United Kingdom
+44 (0)20 7040 8379
andreas.kappes@city.ac.uk

Type

Scientific

Additional contact

Ms Stephanie Cerce

ORCID ID

https://orcid.org/0000-0001-7733-3274

Contact details

The Angel Centre
Saint Philip's Place
Salford
M3 6FA
United Kingdom
01612126457
stephanie@mindinsalford.org.uk

Type

Public

Additional contact

Mr Markus Greenwood

ORCID ID

Contact details

The Angel Centre
Saint Philip's Place
Salford
M3 6FA
United Kingdom
01612124881
markus@mindinsalford.org.uk

Type

Public

Additional contact

Ms Miia Chambers

ORCID ID

Contact details

8-10 Tudor Road
London
E9 7SN
United Kingdom
020 8525 2326
Miia.Chambers@mindchwf.org.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ETH1819-1082

Study information

Scientific title

A randomised controlled trial of an 8-week mindfulness and compassion based self-care intervention tailored for the LGBTQIA+ community

Acronym

RadSec RCT

Study hypothesis

1. Participants who completed the 8-wk RadSec intervention will report significant improvement in their mental health and wellbeing (GHQ-12) post-intervention and this improvement will be maintained at the 4-months follow-up
2. The effects of the intervention on participants' well-being will be mediated via the cultivation of a self-compassionate and mindful (i.e., nonjudgmental or nonreactive) attitude towards oneself and difficult internal states

Ethics approval

Approved 19/06/2019, City, University of London, Psychology Research Ethics Committee (Department of Psychology, City, University of London, Northampton Square, London, EC1V 0HB, United Kingdom; +44 (0)20 7040 5060; psychology.ethics@city.ac.uk), ref: ETH1819-1082

Study design

Multi-centre interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Mental health and well-being of the LGBTQIA+ community

Intervention

The target intervention condition is a novel 8-week mindfulness-based compassion intervention tailored to the unique lived-experiences and psychological struggles of LGBTQIA+ individuals. The core of the novel intervention is grounded in the existing 8-week Mindfulness-Based Stress Reduction and Mindful Self-Compassion courses with theoretical and neuroscience underpinnings from Compassion Focused Therapy, with an emphasis on building self-compassion and mindfulness skills. The intervention is tailored to support LGBTQIA+ -specific issues including low self-esteem, internalised stigma, and shame.

The participants are randomised into two groups by the intervention coordinator following a randomisation schedule generated by the researchers using an online randomisation tool.

There are two study arms – one arm receives an 8-week Radical Self-care (RadSec) intervention; the other arms is a waitlist control which receives the RadSec intervention 8 weeks after the active group complete their intervention (i.e. 16 weeks from the start of the trial). RadSec is an 8-week mindfulness-based self-compassion intervention: The core of the novel intervention is grounded in the existing 8-week Mindfulness-Based Stress Reduction and Mindful Self-Compassion courses, with an emphasis on building self-compassion and mindfulness skills. The intervention is tailored to support LGBT-specific issues including low self-esteem, internalised stigma, and shame.

Outcomes are measured by the General Health Questionnaire-12 at baseline, 8-weeks and 4-months post-randomisation. The effectiveness will be evaluated against a waitlist control condition.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

General well-being and mental health measured by the GHQ-12 at baseline, after 8 weeks (completion of intervention) and 4 months post randomisation

Secondary outcome measures

Assessed at baseline, after 8 weeks and 4 months):
1. Anxiety measured using the GAD-7
2. Depression measured using the PHQ-9
3. Shame measured using the Experience of shame scale
4. Mindfulness measured using the FFMQ-15
5. Self-compassion measured using the Self-compassion scale (SCS)
6. Rigid perfectionism and self-critical perfectionism measured using the subscales from the Big Three Perfectionism Scale
7. Rumination measured using the subscale of the RRQ
8. Concern for self, measured using a belief updating task

Process of change measures (assessed weekly over the 8 weeks):
9. Mindfulness measured using the FFMQ-15
10. Self-compassion measured using the Self-compassion scale - short form (SCS-SF)
11. Cognitive fusion measured using the cognitive fusion questionnaire (CFQ)
12. Rumination measured using the subscale of the RRQ
13. Depression, anxiety, and stress measured using the DASS-21

Overall trial start date

25/01/2019

Overall trial end date

30/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Self-identified LGBTQIA+ individuals
2. Aged 18 years or older

Participant type

Other

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Current suicidal intentions at the time of participant recruitment

Recruitment start date

20/06/2019

Recruitment end date

01/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Mind in the City, Hackney, and Waltham Forrest
8-10 Tudor Road Hackney
London
E9 7SN
United Kingdom

Trial participating centre

Mind in Salford
The Angel Centre 1 St. Philips Place
Salford
M3 6FA
United Kingdom

Trial participating centre

LGBT Foundation
5 Richmond St
Manchester
M1 3HF
United Kingdom

Sponsor information

Organisation

City, University of London

Sponsor details

Northampton Square
Clerkenwell
London
EC1V 0HB
United Kingdom
+44 (0)20 7040 5060
lucie.zernerova.1@city.ac.uk

Sponsor type

University/education

Website

https://www.city.ac.uk/

Funders

Funder type

Government

Funder name

Government Equalities Office

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results of the trial will be reported and published via:
1. Peer-reviewed journals
2. Internal and funder reports
3. Conference and wider public presentations
4. Publication on the project website
5. Publication in a Radical Self-Care Practitioner Guide

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository (OSF website, further details and links will be provided in the due course).

Intention to publish date

29/05/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

21/01/2020: Trial’s existence confirmed by City, University of London, Psychology Research Ethics Committee.