Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001189910
Ethics application status
Approved
Date submitted
3/09/2020
Date registered
10/11/2020
Date last updated
10/11/2020
Date data sharing statement initially provided
10/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mindful Self-Compassion training to improve mental health outcomes for lesbian, gay, bisexual, trans, queer or questioning, intersex, asexual and other diverse genders and sexualities (LGBTQIA+) youth
Scientific title
The effect of Mindful Self-Compassion training on mental health of LGBTQIA+ youth: A randomized controlled trial of group self-compassion training delivered via videoconference
Secondary ID [1] 300811 0
Nil known
Universal Trial Number (UTN)
U1111-1254-6500
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 316689 0
Anxiety 316690 0
Stress 316691 0
Condition category
Condition code
Mental Health 314935 314935 0 0
Depression
Mental Health 314936 314936 0 0
Anxiety
Mental Health 317264 317264 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindful self-compassion training is an 8-week group program involving psychoeducation, group and pair reflective exercises, and meditation practice. These activities focus on cultivating mindfulness, becoming aware of barriers to mindfulness and self-compassion, such as self-criticism, and meditation practices such as loving-kindness meditation, self-compassion meditation, and interpersonal meditation practices. It comprises 8 weekly group sessions of 2-2.5 hours duration, facilitated by a trained Mindful Self-Compassion facilitator. In the present study the program will be co-facilitated by a peer facilitator who is not a trained facilitator of Mindful Self-Compassion. The sessions will be delivered via videoconferencing software (Zoom).
Both facilitators will receive supervision from a clinical psychologist. Participants receive the following materials: a workbook with outlines and key practices for each session (the workbook is part of the standard materials for the Mindful Self-Compassion program described in Neff and Germer (2012; nb the workbook is not publicly available), and audio recordings of meditation practices. A session attendance checklist will be used to monitor adherence. Participants are encouraged to complete meditation practice out-of-session however this is not compulsory.
Intervention code [1] 317140 0
Behaviour
Intervention code [2] 317141 0
Prevention
Comparator / control treatment
Wait list control.. The wait list group will receive the intervention after the 16 week follow-up.
Control group
Active

Outcomes
Primary outcome [1] 323251 0
Self-compassion (scores on Self-Compassion Scale - Short Form)
Timepoint [1] 323251 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [1] 381304 0
Depression (scores on the 9 item Patient Health Questionnaire)
Timepoint [1] 381304 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [2] 381305 0
Emotion regulation difficulties (Scores on the Difficulties in Emotion Regulation Short Form)
Timepoint [2] 381305 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [3] 381306 0
Anxiety (Scores on the 7-item Generalized Anxiety Disorder scale )
Timepoint [3] 381306 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [4] 381307 0
Perceived stress (Scores on the 10-item Perceived Stress Scale)
Timepoint [4] 381307 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [5] 386550 0
Self-criticism (scores on the Forms of Self-Criticism and Self-Reassurance Scale)
Timepoint [5] 386550 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline
Secondary outcome [6] 387505 0
Intervention acceptability will be explored using qualitative data from interviews conducted at the end of the program
Timepoint [6] 387505 0
10 weeks post-baseline, 16 weeks post-baseline, 24 weeks post-baseline

Eligibility
Key inclusion criteria
Participants must be lesbian, gay, bisexual, trans, queer or questioning, intersex, asexual or other diverse genders and sexualities to be included in the study
Participants must be 18-25 years old to be included in the study
Participants must live in Australia to be included in the study
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unable to commit to completing at least 80% of course sessions
Participants will be excluded if they have elevated suicide risk at screening, as assessed using the Columbia Suicide Severity Rating Scale.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis: To test the primary hypotheses, we will run a series of Generalized Linear Mixed Models (GLMMs) – one for each of the six outcome measures. Each of the GLMMs will include two nominal random effects (participant and site), one nominal fixed effect (condition: Mindful Self Compassion and Wait List Control), one ordinal fixed effect (time: pre, post, and 6-month follow-up), and the Condition×Time interaction. We will run separate GLMMs for each outcome, in order to optimise the likelihood that the GLMM solution will converge; sample size estimates were based on a Bonferroni-corrected alpha (0.05/6 = 0.008) to account for multiple statistical tests.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/10/2020
Date of last participant enrolment
Anticipated
23/07/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
96
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305267 0
Charities/Societies/Foundations
Name [1] 305267 0
Australian Rotary Health
Country [1] 305267 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kids Institute
Address
Telethon Kids Institute
15 Hospital Avenue
Nedlands
WA 6009
Country
Australia
Secondary sponsor category [1] 305629 0
None
Name [1] 305629 0
Address [1] 305629 0
Country [1] 305629 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305611 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 305611 0
35 Stirling Hwy, Crawley, WA 6009
Ethics committee country [1] 305611 0
Australia
Date submitted for ethics approval [1] 305611 0
10/03/2020
Approval date [1] 305611 0
14/05/2020
Ethics approval number [1] 305611 0

Summary
Brief summary
The focus of this project is on improving mental health outcomes among Australian young adults (18-25 years) who are lesbian, gay, bisexual, trans and gender diverse, and questioning or queer (LGBTQ).

The main aim of the project is to determine whether participants in an 8 week self-compassion group program (MSC) report improved mental health outcomes compared to a group of participants on a waiting list. We expect that participants in the MSC group will show improvements in self-compassion and emotion regulation as well as reductions in self-stigma and symptoms of depression, anxiety, stress. A second aim of the project is to look at the relationship between those health outcomes to see whether the changes in self-compassion and emotion regulation lead to changes in depression, anxiety and stress. Finally, we will determine whether the program is acceptable to participants and the people delivering the program. To do this, we will conduct interviews with participants, program facilitators and peer facilitators.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100954 0
A/Prof Ashleigh Lin
Address 100954 0
Telethon Kids Institute, 15 Hospital Avenue, Nedlands WA 6009
Country 100954 0
Australia
Phone 100954 0
+61863191291
Fax 100954 0
Email 100954 0
[email protected]
Contact person for public queries
Name 100955 0
Amy Finlay-Jones
Address 100955 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009
Country 100955 0
Australia
Phone 100955 0
+61 8 6319 1808
Fax 100955 0
Email 100955 0
[email protected]
Contact person for scientific queries
Name 100956 0
Amy Finlay-Jones
Address 100956 0
Telethon Kids Institute, 15 Hospital Ave, Nedlands WA 6009
Country 100956 0
Australia
Phone 100956 0
+61 8 6319 1808
Fax 100956 0
Email 100956 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved by ethics


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9048Study protocol  [email protected]
9049Statistical analysis plan  [email protected]
9050Informed consent form  [email protected]
9051Ethical approval  [email protected]



Results publications and other study-related documents

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