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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving mental health of young Australians with chronic illness: A pilot study of the effectiveness of online self-compassion training
Scientific title
Improving mental health of young Australians with chronic illness: A pilot randomised controlled trial of online self-compassion training
Secondary ID [1] 297928 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 312316 0
Condition category
Condition code
Mental Health 310880 310880 0 0
Mental Health 310881 310881 0 0

Study type
Description of intervention(s) / exposure
A 4 week online self-compassion intervention consisting of a total of 4 modules. Each module of the intervention involves reading information and listening to short videos about self-compassion and practicing various meditations that are guided by audio recordings. The intervention aims to increase the young persons self-compassion by practicing skills such as loving-kindness meditations and mindfulness. The 4 week program is designed to be completed over a 4 week period. Each module can be completed in about an hour but participants may choose to take their time and complete modules more slowly. Modules are to be completed once per week over a total of 4 weeks. The intervention is completely self-guided. Video demonstrations are all by a psychologist with expertise in self-compassion training. Participants will be sent automated email reminders to complete modules each week once the program is initiated. Participants will have access to the program for up to 3 months.
Intervention code [1] 314151 0
Comparator / control treatment
Wait-list control. Particiapants will be randomised to either the 4 week intervention immediately or to wait for 4 weeks and then commence the intervention.
Control group

Primary outcome [1] 319704 0
General Psychological Distress measured by Kessler-10 item psychological distress scale (K-10).
Timepoint [1] 319704 0
Baseline (before intervention) and post-intervention (immediately following the 4 week program).
Primary outcome [2] 319705 0
Self-Compassion as measured by Short Form of the Self-Compassion Scale (SCS-SF
Timepoint [2] 319705 0
Baseline (before intervention) and post-intervention (immediately following the 4 week program).
Primary outcome [3] 319706 0
Wellbeing as measured by the World Health Organization Wellbeing Index (WHO-5)
Timepoint [3] 319706 0
Baseline (before intervention) and post-intervention (immediately following the 4 week program).
Secondary outcome [1] 369227 0
Emotion Regulation as measured by the Difficulties in Emotion Regulation Short Form (DERS-SF)
Timepoint [1] 369227 0
Baseline (before intervention) and post-intervention (immediately following the 4 week program).

Key inclusion criteria
Aged between 16-25 years, with a current diagnosis of chronic illnesses (for example arthritis, asthma, cancer, cystic fibrosis, diabetes, epilepsy, haemophilia,
inflammatory bowel disease, lupus, multiple sclerosis, and myalgic encephalomyelitis).
Minimum age
16 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer (qualtrics)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequenced generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people assessing the outcomes
Intervention assignment
Other design features
Wait-list control where all participants eventually receive the intervention
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Intention to Treat and Per Protocol analyses, sensitivity analysis, and compare complete cases
versus cases lost to follow-up on baseline characteristics and scores on clinical measures, by randomization group. GLMM Mixed Model Repeated Measures will compare change in outcome measures across conditions, and time points, while
controlling for random effects including, age and gender. Mechanisms of action, will be tested using multiple mediational
analysis with bias-corrected bootstrap samples in MPlus, to test total and specific indirect effects.

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 302444 0
Name [1] 302444 0
Australian Rotary Health
Address [1] 302444 0
2nd Floor, 43 Hunter Street,
Parramatta NSW 2150
Country [1] 302444 0
Primary sponsor type
Dr Amy Finlay-Jones
School of Psychology
Curtin University
Kent Street
WA 6845
Secondary sponsor category [1] 302346 0
Name [1] 302346 0
Address [1] 302346 0
Country [1] 302346 0

Ethics approval
Ethics application status
Ethics committee name [1] 303113 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 303113 0
Curtin University
Kent Street
WA 6845
Ethics committee country [1] 303113 0
Date submitted for ethics approval [1] 303113 0
Approval date [1] 303113 0
Ethics approval number [1] 303113 0

Brief summary
Chronic physical illness (e.g. diabetes, epilepsy, asthma, autoimmune disease) affects 10-20% of Australian youth and can involve frequent pain, intensive treatment, and major limitations in daily activities. This can have serious impacts on well-being and mental health. In order to address this, we need engaging and accessible interventions to improve
well-being and mental health among young people with chronic conditions. We aim to find out whether online self-compassion training improves mental health and well-being in adolescents and young adults with chronic illness.
Self-compassion involves treating yourself with the same kindness and understanding as you would a good friend. In self-compassion training, people learn to skills to be kinder to themselves and soothe themselves when they are distressed. This helps them to recover from difficult experiences more quickly. Online programs may be preferable for people with a chronic illness as they are accessible and flexible. We have developed a four-week online program to help people learn self-compassion skills. A We will trial the program with young people (16-25 years) with chronic conditions. We will test whether people doing the program have significant improvements in psychological distress and well-being,
compared to people on a waitlist. We will also explore whether any improvements in these outcomes are driven by increases in self-compassion or emotion regulation skills.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 92522 0
Dr Amy Finlay-Jones
Address 92522 0
School of Psychology
Curtin University
Kent Street
WA 6845
Country 92522 0
Phone 92522 0
+61 08 92663442
Fax 92522 0
Email 92522 0
Contact person for public queries
Name 92523 0
Dr Amy Finlay-Jones
Address 92523 0
School of Psychology
Curtin University
Kent Street
WA 6845
Country 92523 0
Phone 92523 0
+61 08 92663442
Fax 92523 0
Email 92523 0
Contact person for scientific queries
Name 92524 0
Dr Amy Finlay-Jones
Address 92524 0
School of Psychology
Curtin University
Kent Street
WA 6845
Country 92524 0
Phone 92524 0
+61 08 92663442
Fax 92524 0
Email 92524 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
What data in particular will be shared?
Primary and secondary outcomes data, demographics
When will data be available (start and end dates)?
Start date: when trial is complete
End data: no end date determined
Available to whom?
Open Access
Available for what types of analyses?
How or where can data be obtained?
What supporting documents are/will be available?
No other documents available
Summary results
No Results