ANZCTR - Registration

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

U1111-1231-4502

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

mental health

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

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]

General Psychological Distress measured by Kessler-10 item psychological distress scale (K-10).

Timepoint [1]

Baseline (before intervention) and post-intervention (immediately following the 4 week program).

Primary outcome [2]

Self-Compassion as measured by Short Form of the Self-Compassion Scale (SCS-SF

Timepoint [2]

Baseline (before intervention) and post-intervention (immediately following the 4 week program).

Primary outcome [3]

Wellbeing as measured by the World Health Organization Wellbeing Index (WHO-5)

Timepoint [3]

Baseline (before intervention) and post-intervention (immediately following the 4 week program).

Secondary outcome [1]

Emotion Regulation as measured by the Difficulties in Emotion Regulation Short Form (DERS-SF)

Timepoint [1]

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?

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]

Charities/Societies/Foundations

Name [1]

Australian Rotary Health

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Amy Finlay-Jones

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University
Kent Street
Bentley
WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/04/2019

Approval date [1]

24/06/2019

Ethics approval number [1]

Summary

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

Public notes

Contacts

Principal investigator

Name

Dr Amy Finlay-Jones

Address

School of Psychology Curtin University Kent Street Bentley WA 6845

Country

Australia

Phone

+61 08 92663442

Fax

amy.finlay-jones@curtin.edu.au

Contact person for public queries

Name

Amy Finlay-Jones

Address

School of Psychology Curtin University Kent Street Bentley WA 6845

Country

Australia

Phone

+61 08 92663442

Fax

amy.finlay-jones@curtin.edu.au

Contact person for scientific queries

Name

Amy Finlay-Jones

Address

School of Psychology Curtin University Kent Street Bentley WA 6845

Country

Australia

Phone

+61 08 92663442

Fax

amy.finlay-jones@curtin.edu.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Open Access

Conditions for requesting access:
• -

What individual participant data might be shared?

• Primary and secondary outcomes data, demographics

What types of analyses could be done with individual participant data?

• Any

When can requests for individual participant data be made (start and end dates)?

From:
Start date: when trial is complete
End data: no end date determined

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• https://osf.io/2hak4

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically