Trial Review

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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 information initially 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] 297796 0
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 312159 0
Disordered Eating Behaviour 312235 0
Condition category
Condition code
Metabolic and Endocrine 310705 310705 0 0
Diabetes
Mental Health 310780 310780 0 0
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] 314040 0
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] 319557 0
Disordered eating behaviour assessed by the Diabetes Eating Problem Survey Revised (DEPS-R; Markowitz et al., 2010).
Timepoint [1] 319557 0
Baseline and at post-intervention.
Primary outcome [2] 322445 0
Feasibility and acceptability of the brief self-compassion program.
Timepoint [2] 322445 0
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] 368661 0
Self care behaviours assessed by the Self Care Inventory-Revised Version (SCI-R; Weinger, Butler, Welch, & La Greca, 2005).
Timepoint [1] 368661 0
Baseline and at post-intervention.
Secondary outcome [2] 368662 0
Diabetes-related distress assessed by the Problems Areas in Diabetes Survey (PAID; Polonsky et al., 1995).
Timepoint [2] 368662 0
Baseline and at post-intervention.
Secondary outcome [3] 368663 0
Self-compassion assessed by the Self-Compassion Scale, short form (SCS-SF; Raes, Pommier, Neff, & Van Gucht, 2011).
Timepoint [3] 368663 0
Baseline and at post-intervention.
Secondary outcome [4] 368664 0
Stress assessed by the Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1993).
Timepoint [4] 368664 0
Baseline and at post-intervention.
Secondary outcome [5] 368665 0
Metabolic control (glycosylated hemoglobin/ HbA1c), collected routinely as part of standard care.
Timepoint [5] 368665 0
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?
No
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
28
Accrual to date
Final
27
Recruitment outside Australia
Country [1] 21368 0
New Zealand
State/province [1] 21368 0
Auckland

Funding & Sponsors
Funding source category [1] 302320 0
University
Name [1] 302320 0
The University of Auckland
Country [1] 302320 0
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] 302200 0
None
Name [1] 302200 0
Address [1] 302200 0
Country [1] 302200 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302993 0
Health and Disability Ethics Committees
Ethics committee address [1] 302993 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 302993 0
New Zealand
Date submitted for ethics approval [1] 302993 0
25/03/2019
Approval date [1] 302993 0
15/04/2019
Ethics approval number [1] 302993 0
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 92102 0
Dr Anna Serlachius
Address 92102 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 92102 0
New Zealand
Phone 92102 0
+64 099233073
Fax 92102 0
Email 92102 0
[email protected]
Contact person for public queries
Name 92103 0
Dr Anna Serlachius
Address 92103 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 92103 0
New Zealand
Phone 92103 0
+64 099233073
Fax 92103 0
Email 92103 0
[email protected]
Contact person for scientific queries
Name 92104 0
Dr Anna Serlachius
Address 92104 0
Department of Psychological Medicine
University of Auckland
Private Bag 92019, Victoria Street West
Auckland 1142
Country 92104 0
New Zealand
Phone 92104 0
+64 099233073
Fax 92104 0
Email 92104 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12086Study protocolBoggiss, 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Boggiss, A. L., Consedine, N. S., Schache, K. R., ... [More Details] 377261-(Uploaded-14-06-2021-10-19-46)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a feasibility study: A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating.2020https://dx.doi.org/10.1136/bmjopen-2019-034452
EmbaseA brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating: a feasibility study.2020https://dx.doi.org/10.1111/dme.14352
N.B. These documents automatically identified may not have been verified by the study sponsor.