Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000572167
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
11/04/2019
Date last updated
1/07/2021
Date data sharing statement initially provided
11/04/2019
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
None
Universal Trial Number (UTN)
U1111-1231-4502
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
Anxiety
Mental Health 310881 310881 0 0
Depression

Intervention/exposure
Study type
Interventional
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
Behaviour
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
Active

Outcomes
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).

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose of the study
Treatment
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
Other design features
Wait-list control where all participants eventually receive the intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
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
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/02/2020
Actual
19/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
137
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 302444 0
Charities/Societies/Foundations
Name [1] 302444 0
Australian Rotary Health
Country [1] 302444 0
Australia
Primary sponsor type
Individual
Name
Dr Amy Finlay-Jones
Address
School of Psychology
Curtin University
Kent Street
Bentley
WA 6845
Country
Australia
Secondary sponsor category [1] 302346 0
None
Name [1] 302346 0
Address [1] 302346 0
Country [1] 302346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303113 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 303113 0
Ethics committee country [1] 303113 0
Australia
Date submitted for ethics approval [1] 303113 0
12/04/2019
Approval date [1] 303113 0
24/06/2019
Ethics approval number [1] 303113 0

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

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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?
Any
How or where can data be obtained?
https://osf.io/2hak4


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo N/A until results are published

Documents added automatically
No additional documents have been identified.