Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000961842p
Ethics application status
Submitted, not yet approved
Date submitted
15/06/2021
Date registered
23/07/2021
Date last updated
23/07/2021
Date data sharing statement initially provided
23/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Self-Compassion Chatbot for Adolescents with Type 1 Diabetes (T1D)
Scientific title
Effect of a Self-Compassion Chatbot (COMPASS) on Psychological and Diabetes-Related Outcomes for Adolescents with Type 1 Diabetes (T1D): A Randomised Controlled Trial of COMPASS Compared to an Active Control Condition
Secondary ID [1] 304456 0
None
Universal Trial Number (UTN)
U1111-1267-1323
Trial acronym
COMPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 322279 0
Condition category
Condition code
Metabolic and Endocrine 319962 319962 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention condition: The self-compassion chatbot app intervention will consist of 2-weeks of conversational lessons delivered daily. Lessons will take approximately 5 to 10 minutes to complete and include audio meditations, interactive text activities (e.g., self-compassion journaling exercises), and short videos from other adolescents and young adults with T1D explaining common struggles and tools which have helped them. The lessons will cover key mindfulness and self-compassion tools, adapted from the evidence-based standardised 8-week adolescent MFY self-compassion program (Bluth et al., 2016). To measure the chatbot use, the chatbot app will measure which exercises have been initiated and completed.

At 3-weeks participants randomised to the intervention condition and who indicated on the consent form that they would be happy to be contacted to participate in an interview, will be invited to participate in a brief interview either over the phone or on zoom conducted by Anna Boggiss. The interviews will occur on a first-in-first serve basis for at least 10 participants, with increased emphasis on including Maori participants to ensure feedback is given to ensure the chatbot is culturally acceptable.
Intervention code [1] 320803 0
Behaviour
Comparator / control treatment
Active control condition: The active control app will consist of written diabetes self-management education and relevant resources complied by diabetes care teams and families with children with T1D. Example topics include exercising, carbohydrate ratios, insulin pump frequently asked questions, exams and diabetes, and resources for school staff. Participants will also be encouraged to use the app daily for 5 to 10 minutes. No usage data will able to be accessed however we will ask participants to self-report their adherence.
Control group
Active

Outcomes
Primary outcome [1] 327838 0
Self-compassion assessed by the Self-Compassion Scale, youth version scale (Neff et al., 2021)
Timepoint [1] 327838 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [1] 396732 0
Diabetes-related distress assessed by the Problem Areas in Diabetes Survey – Teen Version (PAID-Teen; Shapiro et al., 2018)
Timepoint [1] 396732 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [2] 396733 0
Disordered eating behaviour assessed by the Diabetes Eating Problem Survey Revised (DEPS-R; Markowitz et al., 2010)
Timepoint [2] 396733 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [3] 396734 0
Self-Care Behaviours assessed by the Self Care Inventory-Revised Version (SCI-R; Weinger, Butler, Welch, & La Greca, 2005)
Timepoint [3] 396734 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [4] 396735 0
Difficulties in emotion regulation assessed by the Difficulties in Emotion Regulation Scale, short form (DERS-SF; Kaufman et al., 2015)
Timepoint [4] 396735 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [5] 396736 0
Metabolic control (glycosylated hemoglobin/ HbA1c), collected routinely as part of standard care.
Timepoint [5] 396736 0
Participant's most recent HbA1c collected prior to intervention (baseline) and their subsequent measurements closest to 3-month after baseline and 6-month after baseline follow-up time-points.
Secondary outcome [6] 396737 0
Stress as assessed by the Perceived Stress Scale (PSS; Cohen, Kamarck, & Mermelstein, 1993)
Timepoint [6] 396737 0
Baseline, 3-weeks after baseline, and 3-months after baseline.
Secondary outcome [7] 397724 0
Acceptability of the apps.
Timepoint [7] 397724 0
To assess the acceptability of the apps at 3-weeks, participants will be asked qualitative questions to measure their perceptions of their allocated app such as: ‘what did you like about the app and why?’ and ‘how would you make the app better for other teenagers to use in the future?’. Optional qualitative interviews will also be conducted at 3-weeks for those randomised to the chatbot intervention group to ensure the chatbot is engaging and culturally acceptable.
Secondary outcome [8] 398665 0
Use of the apps.
Timepoint [8] 398665 0
For both app conditions, participants will be asked to self-report on how many days they used their allocated app at 3-weeks. The chatbot app software will also measure which excercises have been initiated and completed.

Eligibility
Key inclusion criteria
Adolescents will be eligible for inclusion in the study if they are aged 12 to 16 years, have a diagnosis of type 1 diabetes, and have access to a device that is able to run and support the use of an app.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria includes: (1) non-English speaking adolescents, (2) children with developmental disorders (e.g. Autism Spectrum Disorder), (3) children diagnosed with a serious mental disorder requiring ongoing treatment (e.g. psychosis, or a 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)
Participants will be randomly allocated to receive either the self-compassion chatbot app or the diabetes self-management app. Randomisation will occur online using a computer-generated number sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence 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
Quantitative data: Descriptive statistics will be reported for participant demographics, app usage and ratings, and outcomes at baseline. Pearson’s correlations will be used to explore the relationships between the different outcome measures, demographic characteristics, diabetes characteristics, and current insulin regimen. Data will be tested for violations of statistical assumptions. If all parametric assumptions are met, a series of 2 (group) x 3 (time) mixed analysis of variance (ANOVA) will be conducted as our main analyses to test for between group differences at 3-weeks (for all self-reported measures), 3-months (for all measures), and 6-months (for glycemic control).

Qualitative data: Data gained from the open-feedback questions and interviews at 3-week assessments will be analysed using directed content analysis, a systematic approach for exploring and categorising qualitative data, guided by existing research questions, categories or theories.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/10/2021
Actual
Date of last participant enrolment
Anticipated
28/02/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
74
Accrual to date
Final
Recruitment outside Australia
Country [1] 23763 0
New Zealand
State/province [1] 23763 0

Funding & Sponsors
Funding source category [1] 308816 0
Charities/Societies/Foundations
Name [1] 308816 0
New Zealand Society for the Study of Diabetes
Country [1] 308816 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine,
Level 3, Building 507,
22-30 Park Avenue,
Grafton,
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 309986 0
Charities/Societies/Foundations
Name [1] 309986 0
New Zealand Society for the Study of Diabetes,
Address [1] 309986 0
New Zealand Society for the Study of Diabetes,
73B Cannington Rd,
Maori Hill,
Dunedin 9010
Country [1] 309986 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308729 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 308729 0
Ministry of Health,
133 Molesworth Street,
PO Box 5013,
Wellington 6011
Ethics committee country [1] 308729 0
New Zealand
Date submitted for ethics approval [1] 308729 0
13/07/2021
Approval date [1] 308729 0
Ethics approval number [1] 308729 0

Summary
Brief summary
Adolescents with type 1 diabetes experience high rates of distress, depression, anxiety, and disordered eating behaviours, compared to their healthy peers. Using a pilot randomised controlled trial, we would like to examine any possible improvements in self-compassion, diabetes-related distress, stress, disordered eating behaviour, diabetes self-care behaviours and glycemic control from using a self-compassion chatbot app, compared to those using a diabetes self-management education app. A target of 74 adolescents (aged 12 to 16) will be recruited from the Starship paediatric diabetes outpatient clinics and online. Once participants have consented/ assented to participate they will complete baseline questionnaires and either be given access to the self-compassion chatbot app or a diabetes self-management education app. The self-compassion chatbot will ask participants how they have been lately and how their diabetes self-management is going before starting conversational lessons on self- compassion and mindfulness tools. After 3 weeks, participants will complete questionnaires and then again 3- months after the intervention. We will also collect participants routine glycaemic control (HbA1c) from their clinical records at baseline, 3- and 6-months. Those who live outside of Auckland will be asked to self-report their glycaemic control (HbA1c) at these timepoints.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111690 0
Dr Anna Serlachius
Address 111690 0
Department of Psychological Medicine, University of Auckland
Level 3, Building 507,
22-30 Park Avenue,
Grafton 1023,
Auckland
Country 111690 0
New Zealand
Phone 111690 0
+64 99233073
Fax 111690 0
Email 111690 0
[email protected]
Contact person for public queries
Name 111691 0
Dr Anna Serlachius
Address 111691 0
Department of Psychological Medicine, University of Auckland
Level 3, Building 507,
22-30 Park Avenue,
Grafton 1023,
Auckland
Country 111691 0
New Zealand
Phone 111691 0
+64 99233073
Fax 111691 0
Email 111691 0
[email protected]
Contact person for scientific queries
Name 111692 0
Dr Anna Serlachius
Address 111692 0
Department of Psychological Medicine, University of Auckland,
Level 3, Building 507,
22-30 Park Avenue,
Grafton 1023,
Auckland
Country 111692 0
New Zealand
Phone 111692 0
+64 99233073
Fax 111692 0
Email 111692 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?

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.