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Trial registered on ANZCTR


Registration number
ACTRN12614000974606
Ethics application status
Approved
Date submitted
26/06/2014
Date registered
11/09/2014
Date last updated
17/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Tools for resilience: A mobile phone and web-based intervention for improving mental wellbeing and reducing distress in adolescents and young adults with Type 1 diabetes
Scientific title
In adolescents and adults with diabetes, does a mobile phone and web intervention, compared with a placebo intervention, improve mental wellbeing and reduce distress?
Secondary ID [1] 284873 0
Nil
Universal Trial Number (UTN)
U111-1158-4960
Trial acronym
FIDO - Feeling in charge of Diabetes Online
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 292303 0
Type 1 diabetes 292304 0
Condition category
Condition code
Mental Health 292642 292642 0 0
Depression
Metabolic and Endocrine 292643 292643 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomised to the intervention condition will have full use of a freely available mobile phone and web intervention called 'myCompass' for seven weeks. The intervention has been developed as a self-help intervention with no therapist input for people with mild-to-moderate levels of depression, anxiety and stress.

The intervention allows participants to: (a) monitor moods, symptoms and/or behaviours (e.g. physical activity, depression, anxiety, irritability, sleep, alcohol use, user-defined health signs); (b) schedule short message service (SMS) or email self-monitoring reminders; (c) receive and print graphical feedback about monitoring which is presented alongside meaningful contextual information (i.e., where they were, what they were doing and who they were with at the time of rating); and (d) receive helpful facts, mental health-care tips or motivational statements by SMS or email.

In addition, myCompass offers a number of psychological modules for users to complete via the internet. Modules derive from Cognitive Behaviour Therapy, as well as Interpersonal Psychotherapy, Problem Solving Therapy and Positive Psychology, and cover topics such as Solving Problems, Managing Fear and Anxiety, Tackling Unhelpful Thinking, Managing Loss and Major Life Change. Each module comprises three 10-minute sessions and has practice tasks assigned. Participants may use (or not use) the intervention at their discretion.
Intervention code [1] 289679 0
Treatment: Devices
Comparator / control treatment
Participants randomised to the placebo intervention will use an Internet delivered lifestyle intervention. Developed by the research team to match myCompass on duration and mode of delivery, the program also contains practice activities, home tasks and factual SMS messages to replicate the interactivity of myCompass, but has no therapeutic content. Topics will include skin care, mobile phone use, home environment, casual work, healthy food and relationships. Participants may use (or not use) the full intervention at their discretion across a seven week period.
Control group
Placebo

Outcomes
Primary outcome [1] 292477 0
Psychological wellbeing, assessed using the Warwick-Edinburgh Mental Well-being Scale
Timepoint [1] 292477 0
Baseline and post-intervention only
Primary outcome [2] 292478 0
General psychological distress and functioning (depression, anxiety), as assessed by the Patient Health Questionnaire 9 (PHQ9) and the Generalized Anxiety Disorder-7 (GAD7)
Timepoint [2] 292478 0
Baseline and post-intervention only
Primary outcome [3] 292479 0
Diabetes-specific distress, assessed using the Diabetes Distress Scale
Timepoint [3] 292479 0
Baseline, post-intervention, 3 months
Secondary outcome [1] 309069 0
Diabetes self-care, assessed by Summary of Diabetes Self-Care Activities scale
Timepoint [1] 309069 0
Baseline and post-intervention only
Secondary outcome [2] 309077 0
Mental health self-efficacy, as assesssed by the Mental Health Self-Efficacy Scale
Timepoint [2] 309077 0
Baseline and post-intervention only
Secondary outcome [3] 309281 0
Work and social functioning, as assessed by Work and Social Adjustment Scale
Timepoint [3] 309281 0
Baseline, post-intervention, 3 months
Secondary outcome [4] 310308 0
Self-reported glycaemic control, assessed by the Hyperglycaemia and Hypoglycaemia scales
Timepoint [4] 310308 0
Baseline and post-intervention only

Eligibility
Key inclusion criteria
* Have at least mild diabetes-related distress, as measured by the Diabetes Distress Scale, and/or
* Have at least mild depressive symptoms, as measured by the Patient Health Questionnaire, PHQ-9; and
* Be aged 16 to 25 years;
* Have T1D diabetes, diagnosed by an endocrinologist;
* Have access to an internet-enabled mobile phone and computer/tablet; and
* Provide informed consent.
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Inability to read English with ease;
* Severe mental health problems (i.e., psychotic symptoms);
* Non-residence in Australia; and
* Previous experience with the myCompass program.

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)
Participants will be enrolled into the study following completion of an online screening tool. People who screen as eligible will be automatically directed to the online baseline questionnaire. Researchers will receive an email confirmation once a baseline questionnaire is complete, and participant information will be downloaded and de-identified (i.e., ID numbers allocated). ID numbers will be forwarded to a person outside the research team for randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised 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
Analyses will be based on the intention-to-treat sample and will used mixed modelling techniques to deal with missing data issues that arise as a consequence of study attrition.

The RCT of myCompass yielded an average between-group effect size for the intervention on symptom outcomes of 0.5. Assuming an attrition rate of 50%, a total sample of 240 participants (120 per arm) is the minimum required to detect between-group differences on self-report outcomes of .5 standard deviations with 80% power. Nevertheless, we will recruit 280 participants (140 per arm) as we have pilot data showing that this will enable us to detect a clinically meaningful change in HbA1c (0.3 - 0.5%) with power at 80% (assuming standard deviations between 1 and 1.3).

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
22/09/2014
Actual
29/10/2014
Date of last participant enrolment
Anticipated
Actual
13/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 2675 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 2676 0
Westmead Hospital - Westmead
Recruitment hospital [3] 2677 0
Sydney Children's Hospital - Randwick

Funding & Sponsors
Funding source category [1] 289489 0
Charities/Societies/Foundations
Name [1] 289489 0
Australian Rotary Health
Country [1] 289489 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Black Dog Institute
Address
Hospital Road
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 288174 0
None
Name [1] 288174 0
Address [1] 288174 0
Country [1] 288174 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291245 0
St Vincent's Hospital
Ethics committee address [1] 291245 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 291245 0
Australia
Date submitted for ethics approval [1] 291245 0
03/02/2014
Approval date [1] 291245 0
14/04/2014
Ethics approval number [1] 291245 0
HREC/14/SVH/31

Summary
Brief summary
Young people with Type 1 diabetes are at greater risk of mental health problems and poor psychological wellbeing than their counterparts without diabetes. Young people are high users of mobile and internet-technology, and increasingly use these tools for health information and support.

The project’s primary objective is to test the hypotheses that psychological well-being will be significantly improved, and that symptoms of psychological (i.e., depression, anxiety and stress) and diabetes-related distress will be significantly reduced, in participants who use a mobile phone and web-based mental health intervention, myCompass, for seven weeks compared with those in a placebo control group.

The project’s secondary objective is to test the hypothesis that diabetes self-care, work and social functioning, glycaemic control (glycosylated haemoglobin, HbA1c), and quality of life will be significantly improved for participants who receive the myCompass intervention.
Trial website
https://fido.ehat.com.au/
Trial related presentations / publications
Clarke et al., A mobile phone and web-based intervention for improving mental wellbeing in young people with type 1 diabetes: Design of a randomised controlled trial. JMIR Res Protoc 2015, 4:e50
doi:10.2196/resprot.4032
http://dx.doi.org/10.2196/resprot.4032
Public notes

Contacts
Principal investigator
Name 49486 0
A/Prof Judy Proudfoot
Address 49486 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 49486 0
Australia
Phone 49486 0
+61 2 9382 3767
Fax 49486 0
Email 49486 0
[email protected]
Contact person for public queries
Name 49487 0
Janine Clarke
Address 49487 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 49487 0
Australia
Phone 49487 0
+61 2 9382 3719
Fax 49487 0
Email 49487 0
[email protected]
Contact person for scientific queries
Name 49488 0
Janine Clarke
Address 49488 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 49488 0
Australia
Phone 49488 0
+61 2 9382 3719
Fax 49488 0
Email 49488 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



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