ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000541101

Ethics application status

Approved

Date submitted

28/03/2019

Date registered

5/04/2019

Date last updated

16/06/2021

Date data sharing statement initially provided

5/04/2019

Date results provided

16/06/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Brief Self-Compassion Intervention for Adolescents with Type 1 Diabetes and Disordered Eating Behaviour

Scientific title

Brief Self-Compassion Intervention for Adolescents with Type 1 Diabetes and Disordered Eating Behaviour: A Feasibility Study

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1227-4757

Trial acronym

Linked study record

Health condition

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

Type 1 Diabetes

Disordered Eating Behaviour

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Mental Health

Eating disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study is a randomised controlled trial where participants will participate in a brief self-compassion intervention, either starting straight away (intervention group) or starting the following weekend after the intervention group finishes (wait-list control group).

The brief self-compassion intervention will involve two 2.5 hour sessions (one week apart) in groups of 14 participants and will include group activities, meditations and individual reflections. Themes and topics of these activities will include: mindful self-compassion, mindfulness, adolescent brain development and self-esteem vs self-compassion. These activities are taken from the 'Making Friends with Yourself' self-compassion 8-week program for teens teacher manual, with permission given from the developer, Karen Bluth. As per the standardised 8-week program, participants will be given the standardised handout booklet (only including activities that are incorporated in this brief version) and audio recordings of meditations (made available by Karen Bluth's 'Making Friends with Yourself' program). Participants are given examples of situations to use these resources (e.g., mindfulness activities, meditations) and encouraged to try out the different activities to find ones that work well for them.

The sessions will be conducted at the University of Auckland Grafton Campus, face-to-face. The sessions will be conducted by a trained teacher of the 'Making Friends with Yourself' self-compassion program for teens, who is also a PhD candidate.

Intervention code [1]

Behaviour

Comparator / control treatment

The waitlist control group will receive the intervention, the weekend after the intervention group finishes.

Control group

Active

Outcomes

Primary outcome [1]

Disordered eating behaviour assessed by the Diabetes Eating Problem Survey Revised (DEPS-R; Markowitz et al., 2010).

Timepoint [1]

Baseline and at post-intervention.

Primary outcome [2]

Feasibility and acceptability of the brief self-compassion program.

Timepoint [2]

Feasibility and acceptability will be assessed throughout the study by: (1) evaluating whether adolescents with T1D are willing to participate in the intervention (i.e. recruitment and uptake), (2) reasons for not wanting to participate, (3) the acceptability of the delivered intervention (assessed via qualitative questions), (4) study attrition rate, and (5) the suitability of outcome measures.

Secondary outcome [1]

Self care behaviours assessed by the Self Care Inventory-Revised Version (SCI-R; Weinger, Butler, Welch, & La Greca, 2005).

Timepoint [1]

Baseline and at post-intervention.

Secondary outcome [2]

Diabetes-related distress assessed by the Problems Areas in Diabetes Survey (PAID; Polonsky et al., 1995).

Timepoint [2]

Baseline and at post-intervention.

Secondary outcome [3]

Self-compassion assessed by the Self-Compassion Scale, short form (SCS-SF; Raes, Pommier, Neff, & Van Gucht, 2011).

Timepoint [3]

Baseline and at post-intervention.

Secondary outcome [4]

Stress assessed by the Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1993).

Timepoint [4]

Baseline and at post-intervention.

Secondary outcome [5]

Metabolic control (glycosylated hemoglobin/ HbA1c), collected routinely as part of standard care.

Timepoint [5]

The most recent HbA1c collected prior to intervention and at 4-weeks follow-up.

Eligibility

Key inclusion criteria

Adolescents will be eligible if they score both moderate (scoring 10 and above) and high (scoring 20 or above) levels of disordered eating behaviour.

Minimum age

12 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria include: (1) non-English speaking adolescents, (2) children with developmental disorders (e.g. Autism Spectrum Disorder, ADHD), (3) children diagnosed with a serious mental disorder requiring ongoing treatment (e.g. psychosis, diagnosed eating disorder), (4) children with untreated hypothyroidism, and (5) children recently (in previous 48 hours) diagnosed with DKA or severe hypoglycaemia.

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)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer-based random number generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Pearsons correlations will be used to explore the relationships between the different outcome measures, demographic characteristics, disease characteristics, and current insulin regimen. An independent samples t-test will be conducted at post-intervention (to compare the intervention group with the waitlist control group, before they start the intervention) and will be our main analysis. This test will test our hypothesis for differences between groups in disordered eating behaviour, diabetes-related distress, stress, self-care behaviours and self-compassion. An independent samples t-test will also be conducted at the 12-week follow-up to assess any possible differences between groups for glycaemic control. An exploratory analysis will also combine post-intervention data from participants in both groups to examine changes from baseline, using a paired samples t-test.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

8/05/2019

Actual

24/05/2019

Date of last participant enrolment

Anticipated

Actual

29/10/2019

Date of last data collection

Anticipated

Actual

1/03/2020

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Auckland

Address [1]

Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country [1]

New Zealand

Primary sponsor type

University

Name

The University of Auckland

Address

Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

25/03/2019

Approval date [1]

15/04/2019

Ethics approval number [1]

Research project number A+8467

Summary

Brief summary

Adolescents with type 1 diabetes are at an increased risk for developing disordered eating behaviours. Using a pilot randomised controlled trial, we would like to examine the feasibility of a brief self-compassion intervention (two 2-hour sessions) and examine any improvements in disordered eating behaviour, self-compassion, self-care behaviours, diabetes-related distress, stress and glycaemic control four weeks after the intervention. We also plan to measure the prevalence of disordered eating behaviour in the clinic population. At least fifty adolescents will be recruited from the diabetes outpatient clinic at Greenlane Clinical Centre. Once participants have consented/assented to participate they will complete a survey measuring disordered eating behaviours. If they score above the cut-off score they will be invited to participate in the intervention and either be randomised into the intervention group (self-compassion intervention) or the waitlist control group (who will receive the intervention four weeks after the intervention group). The intervention will occur in groups of 10-14 and involve group exercises, meditations and individual reflections to teach teens to be more kind to themselves. Participants will complete questionnaires before the intervention and immediately after. We will also examine baseline glycaemic control (HbA1c) when participants are recruited and three months later at their next clinic appointment.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Anna Serlachius

Address

Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 099233073

Fax

a.serlachius@auckland.ac.nz

Contact person for public queries

Name

Anna Serlachius

Address

Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 099233073

Fax

a.serlachius@auckland.ac.nz

Contact person for scientific queries

Name

Anna Serlachius

Address

Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142

Country

New Zealand

Phone

+64 099233073

Fax

a.serlachius@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12086	Study protocol	Boggiss, A. L., Consedine, N. S., Jefferies, C., Bluth, K., Hofman, P. L., & Serlachius, A. S. (2020). Protocol for a feasibility study: a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating. BMJ Open, 10(2).				377261-(Uploaded-14-06-2021-10-21-37)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating: a feasibility study.	2020	https://dx.doi.org/10.1111/dme.14352
Embase	Protocol for a feasibility study: A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating.	2020	https://dx.doi.org/10.1136/bmjopen-2019-034452

N.B. These documents automatically identified may not have been verified by the study sponsor.

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