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Trial registered on ANZCTR


Registration number
ACTRN12623000610639
Ethics application status
Approved
Date submitted
26/09/2022
Date registered
2/06/2023
Date last updated
2/06/2023
Date data sharing statement initially provided
2/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can compassionate mind training help with self-criticism for university students
Scientific title
Can compassionate mind training help with self-criticism for university students: A randomised controlled trial
Secondary ID [1] 308035 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
self-criticism 327718 0
perfectionism 327719 0
Condition category
Condition code
Mental Health 324791 324791 0 0
Depression
Mental Health 327034 327034 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Compassionate Mind Training is an 8 session course, that is 2.5 hours each session, with each session delivered weekly (so over 8 week period). The program is delivered face to face in a group format (size ranges from 8-20) with a facilitator. The facilitator being a clinical psychologist with training in Compassion Focused Therapy. The mode of training used include didactic presentation of psycoeducation of material, experiential exercises of meditations and imagery practices, and pair and group work. The participants are guided through CMT training, all based on Gilbert's (2014) model of compassion to help with self-critcism. The manual used is the one based on irons & Hertiot-Maitland (2020), which includes 8 sessions.

Below is what each session covers:
Session 1: Exploration of the evolutionary based, CFT definition of what compassion is, the reality checks of how and why we suffer, and an introduction to the concept of the ‘tricky brain’ and loops in the mind

Session 2: Exploration of the three system model of emotions – threat, drive and soothing – along with ideas about how to balance the systems in a way that may lead to less distress, and more well-being in life

Session 3: Explore the concept of self as full of multiple ‘parts’, rather than unitary, and of compassion as a self-identity. Practices involved ways to develop the ‘compassionate self’

Session 4: Introduction of the concept of compassion as flow (to others, from others and to self), with a focus on directing the compassionate self to others. Discussion of what can make being compassionate to others difficult (i.e., the fears, blocks and resistances to compassion for others)

Session 5: Discussion about the importance of being open to care and compassion from others, including what can get in the way of this (i.e., the fears, blocks and resistances of compassion)

Session 6: Focus on self-compassion, including various practices and an exploration of what can block this (the fears, blocks and resistances to self-compassion)

Session 7: Exploration of self-criticism, its functions and how to direct compassion to it, and to the reasons for why it operates as it does. Exploration of how the compassionate mind can be used to approach an upcoming difficulty.

Session 8: Exploring how to explore different emotional reactions to a difficulty (multiple selves), and how compassion can support this process. Exploration of different ways to extend compassion to oneself, and how to take a compassionate approach to the future

In each program a research assistant (a psychology masters student) will be completing a protocol adherence checklist.
Intervention code [1] 324486 0
Behaviour
Comparator / control treatment
A waitlist control comparison, which will be offered the intervention after completion of time 2 measures, which is 8 weeks after Time 1 measures.
Control group
Active

Outcomes
Primary outcome [1] 332625 0
self-criticism, will be assessed using the Forms of Self-Criticising/Attacking and Self-Reassuring Scale

Gilbert, P., Clark, M., Hempel, S., Miles, J.N.V. & Irons, C. (2004). Criticising
and reassuring oneself: An exploration of forms, styles and reasons in female
students. British Journal of Clinical Psychology, 43, 31-50.
Timepoint [1] 332625 0
post-intervention completion, immediately following the 8 weeks
Primary outcome [2] 332626 0
self-compassion, will be measured using the Compassionate Motivation and Action Scale

Steindl, S. R., Tellegen, C. L., Filus, A., Seppala, E., Doty, J. R., & Kirby, J. N. (2021). The Compassion Motivation and Action Scales: A self-report measure of compassionate and self-compassionate behaviours. Australian Psychologist, 56(2), 93-110. https://doi.org/10.1080/00050067.2021.1893110
Timepoint [2] 332626 0
post-intervention completion, immediately following the 8 weeks
Secondary outcome [1] 414109 0
perfectionism, will be measured using the Multidimensional Perfectionism Scale-Short Form

Hewitt, P. L., & Flett, G. L. (1991). Perfectionism in the self and social contexts: Conceptualization, assessment, and association with psychopathology. Journal of Personality and Social Psychology, 60(3), 456–470. https://doi.org/10.
1037/0022-3514.60.3.456
Timepoint [1] 414109 0
post-intervention completion, immediately following the 8 weeks
Secondary outcome [2] 414110 0
depression, using the Depression Anxiety Stress Scales

Lovibond, P. F., & Lovibond, S. H. (1995). The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behaviour Research and Therapy, 33(4), 335–343. https://doi.org/10.1007/BF02511245
Timepoint [2] 414110 0
post-intervention completion, immediately following the 8 weeks

Eligibility
Key inclusion criteria
over 18 years, enrolled university student, speak and read english, and has moderate levels of self-criticism
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cannot attend sessions and cannot speak english

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
by a random number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
a series of manovas and anovas will be used to examine group and time effects of the intervention

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2022
Date of last participant enrolment
Anticipated
1/07/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
80
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312295 0
University
Name [1] 312295 0
The University of Queensland
Country [1] 312295 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
The School of Psychology, The University of Queensland, St Lucia, Brisbane 4072 Queensland
Country
Australia
Secondary sponsor category [1] 313843 0
None
Name [1] 313843 0
Address [1] 313843 0
Country [1] 313843 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311664 0
Human Research Ethics Approval University of Queensland
Ethics committee address [1] 311664 0
Ethics committee country [1] 311664 0
Australia
Date submitted for ethics approval [1] 311664 0
Approval date [1] 311664 0
13/10/2021
Ethics approval number [1] 311664 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121910 0
Dr James Kirby
Address 121910 0
The School of Psychology, The University of Queensland, St Lucia, Brisbane 4072 Queensland
Country 121910 0
Australia
Phone 121910 0
+61 7 3365 6802
Fax 121910 0
Email 121910 0
j.kirby@psy.uq.edu.au
Contact person for public queries
Name 121911 0
James Kirby
Address 121911 0
The School of Psychology, The University of Queensland, St Lucia, Brisbane 4072 Queensland
Country 121911 0
Australia
Phone 121911 0
+61 7 3365 6802
Fax 121911 0
Email 121911 0
j.kirby@psy.uq.edu.au
Contact person for scientific queries
Name 121912 0
James Kirby
Address 121912 0
The School of Psychology, The University of Queensland, St Lucia, Brisbane 4072 Queensland
Country 121912 0
Australia
Phone 121912 0
+61 7 3365 6802
Fax 121912 0
Email 121912 0
j.kirby@psy.uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
non-identifiable data will be shared, specifically data from the measures
When will data be available (start and end dates)?
On completion of the trial, so by 1/04/2024. No end date for data availability
Available to whom?
All scientists
Available for what types of analyses?
any
How or where can data be obtained?
When data is all collected, will make it available on James Kirby's open science framework page https://osf.io/dashboard or you can contact j.kirby@psy.uq.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.