Rainbow Mind: Examining the effectiveness and mechanisms of change of a mindfulness and compassion based self-care intervention tailored for the LGBTQIA+ community
| ISRCTN | ISRCTN11568927 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11568927 |
| Secondary identifying numbers | ETH1819-1082 |
- Submission date
- 04/12/2019
- Registration date
- 12/02/2020
- Last edited
- 01/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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 March 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
Contact information
Scientific
City, University of London
Northampton Square
London
EC1V 0HB
United Kingdom
 ORCID ID |
0000-0003-0099-4335 |
|---|---|
| Phone | +44 (0)20 7040 5060 |
| Lucie.Zernerova.1@city.ac.uk |
Scientific
City, University of London
Northampton Square
London
EC1V 0HB
United Kingdom
| ORCID ID |
0000-0002-6417-2499 |
|---|---|
| Phone | +44 (0)20 7040 8484 |
| Paul.Flaxman.1@city.ac.uk |
Scientific
City, University of London
Northampton Square
London
EC1V 0HB
United Kingdom
| ORCID ID |
0000-0003-0867-6630 |
|---|---|
| Phone | +44 (0)20 7040 8379 |
| andreas.kappes@city.ac.uk |
Scientific
The Angel Centre
Saint Philip's Place
Salford
M3 6FA
United Kingdom
| ORCID ID |
0000-0001-7733-3274 |
|---|---|
| Phone | 01612126457 |
| stephanie@mindinsalford.org.uk |
Public
The Angel Centre
Saint Philip's Place
Salford
M3 6FA
United Kingdom
| Phone | 01612124881 |
|---|---|
| markus@mindinsalford.org.uk |
Public
8-10 Tudor Road
London
E9 7SN
United Kingdom
| Phone | 020 8525 2326 |
|---|---|
| Miia.Chambers@mindchwf.org.uk |
Study information
| Study design | Multi-centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial of an 8-week mindfulness and compassion based self-care intervention tailored for the LGBTQIA+ community |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 25/01/2019 |
| Overall study end date | 11/03/2020 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 118 |
| Participant inclusion criteria | 1. Self-identified LGBTQIA+ individuals 2. Aged 18 years or older |
| 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
- England
- United Kingdom
Study participating centres
Hackney
London
E9 7SN
United Kingdom
1 St. Philips Place
Salford
M3 6FA
United Kingdom
Manchester
M1 3HF
United Kingdom
Sponsor information
University/education
Northampton Square
Clerkenwell
London
EC1V 0HB
England
United Kingdom
| Phone | +44 (0)20 7040 5060 |
|---|---|
| lucie.zernerova.1@city.ac.uk | |
| Website | https://www.city.ac.uk/ |
"ROR" |
https://ror.org/04489at23 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | 01/09/2020 | 10/09/2021 | No | No |
Editorial Notes
01/08/2023: The intention to publish date has been changed from 01/03/2023 to 01/12/2023.
16/12/2022: The intention to publish date was changed from 29/12/2021 to 01/03/2023.
10/09/2021: Funder report added.
21/06/2021: The intention to publish date has been changed from 29/05/2021 to 29/12/2021.
11/12/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/12/2020 to 11/03/2020.
2. The intention to publish date was changed from 29/05/2020 to 29/05/2021.
3. Total final enrolment number added.
21/01/2020: Trial’s existence confirmed by City, University of London, Psychology Research Ethics Committee.
