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Trial registered on ANZCTR


Registration number
ACTRN12615000931572
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
7/09/2015
Date last updated
21/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The springboarD trial: Trial of a self-help intervention to improve functioning and emotional well-being for people with type 2 diabetes
Scientific title
The springboarD trial: Trial of a self-help intervention to improve functioning and emotional well-being for depression and diabetes-related distress in people with type 2 diabetes
Secondary ID [1] 286303 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 294393 0
Type 2 diabetes 294394 0
Condition category
Condition code
Mental Health 294701 294701 0 0
Depression
Metabolic and Endocrine 294702 294702 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active intervention ("myCompass") is a fully-automated, self-help, public health intervention, that is tailored to the user and has no therapist input. Real-time self-monitoring of symptoms (e.g., problem moods, thoughts and behaviours) via mobile phone and/or computer/tablet is a key therapeutic feature. Users can self-monitor three symptoms of their choice at any one time, selected from a list of 20, or three that are recommended to them by the program (e.g., confidence, worry, irritability, motivation, diet, and medication use). Each symptom is rated on a 10-point scale (e.g., “how confident do you feel right now”, “how worried do you feel right now”, “how satisfied are you that you have taken your prescribed medication today”). At the time of rating, users also provide contextual information about where they are, what they are doing and who they are with, using a series of drop-down menus. To improve adherence to the intervention users can schedule short message service (SMS) or email reminders to facilitate self-monitoring (frequency of reminders determined by the user); receive and print graphical feedback about their monitoring, including contextual information, on their phone or computer (to monitor change and assist identification of triggers); and elect to receive helpful facts, mental health-care tips or motivational statements by SMS or email.
The myCompass program offers evidence-based and interactive psychological modules that users can complete via the internet on their computers. The program contains 12 skill-building modules derived from CBT, Interpersonal Psychotherapy, Problem-solving Therapy and Positive Psychology that cover topics such as Managing Fear and Anxiety, Tackling Unhelpful Thinking, Managing Loss and Major Life Change, and Solving Problems. Each module comprises three 10-minute sessions and includes activities for users to complete on the computer. There are home practice tasks recommended for participants to complete between the weekly online sessions (i.e. completion of one full module per week), which are intended to promote skill generalisation. Users can, however, complete the modules of their choice and at their own pace, and/or those recommended to them by the myCompass program. As part of the myCompass registration process, program users complete a profile questionnaire, responses to which are used to tailor the self-monitoring and module recommendations. Specifically, this questionnaire asks users to rate the extent to which they experience a range of symptoms of depression, anxiety, and stress (e.g., worry, irritability, difficulties with motivation and concentration). Targeting the three highest rated symptoms, in-built algorithms generate personalised feedback to the user about the self-monitoring dimensions and psychological modules that may be of greatest benefit (i.e., each dimension and module is weighted according to its clinical relevance for each symptom, and those with the highest weightings are recommended). Participants will have 8 weeks to undertake the myCompass program, with a 4 week tailing off period. During this 4 week tailing off period, myCompass users will only have access to the real-time self-monitoring of symptoms (e.g., problem moods, thoughts and behaviours), but will not have access to any Module content and activities.

Intervention code [1] 291345 0
Treatment: Other
Intervention code [2] 292674 0
Behaviour
Comparator / control treatment
The placebo control intervention ("Healthy Lifestyles") is an online and interactive health information program which provides information about a range of health topics including environmental and community health, stress and wellbeing, sustainable living, healthy skin and eye health, safe road usage, and travelling. The program has no therapeutic content, and has been successfully used as a placebo in previous studies by members of the research team. Participants in the placebo control group will similarly have access to the intervention for 8 weeks with a tailing off of 4 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 294468 0
Functioning (Work and Social Adjustment Scale)
Timepoint [1] 294468 0
3 months after commencement of intervention.
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [1] 313376 0
Diabetes-related Distress, as measured by the Diabetes Distress Scale (DDS).
Timepoint [1] 313376 0
3 months after commencement of intervention.
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [2] 313379 0
Depressive symptoms, as measured by the Patient Health Questionnaire (PHQ-9).
Timepoint [2] 313379 0
3 months after commencement of intervention.
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [3] 313380 0
Diabetes-related Self-Care, as assessed by the Self-management Profile for Type 2 Diabetes scale (SMP-T2D).
Timepoint [3] 313380 0
3 months after commencement of intervention.
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [4] 313383 0
Glyclemic control (average over previous 3 months), as measured by hemoglobin A1c (HbA1c) pathology data.
Timepoint [4] 313383 0
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [5] 316180 0
Self-report assessment of health services usage for diabetes (e.g. frequency of visits to doctor and hospital in previous 6 weeks for diabetes-related problems) and mental health concerns (e.g. frequency of use in previous 6 weeks, and type of services employed, for mental health support).
Timepoint [5] 316180 0
3 months after commencement of intervention.
6 months after commencement of intervention.
12 months after commencement of intervention.
24 months after commencement of intervention.
Secondary outcome [6] 327863 0
Anxiety symptoms: as assessed by the GAD-7
Timepoint [6] 327863 0
Measured at baseline and 3-, 6-, 12- and 24-months post intervention.

Eligibility
Key inclusion criteria
- Have type 2 diabetes, diagnosed by a general practitioner (GP) or endocrinologist;
- Be aged between 18 and 75 years;
- Screen positive for depressive symptoms (as measured by the Patient Health Questionnaire-9, PHQ-9);
- Have access to the Internet
- Have a valid email address; and
- Provide informed consent.
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include:
- Inability to read English with ease;
- Psychotic symptoms (as measured by the Psychosis Screening Questionnaire; PSQ);
- Have extremely severe depression (as measured by the PHQ-9);
- Currently receiving face-to-face treatment for depression (or looking to receive treatment in the next 3 months);
- High suicide risk (as measured by the PHQ-9);
- Currently receiving face-to-face treatment for depression;
- Changed antidepressant medication in the previous 2 months;
- 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 invited to enrol in the study via a generic letter prepared by the researchers but mailed from their doctor, or from the general community. Interested participants will visit the study website to enrol and complete screening measures.
Participants who pass the eligibility criteria (automated) will then be randomised using computerised random numbers procedure. Members of the research team will not be involved in the randomisation process, and only the trial manager and an off-site research assistant will know the group to which a participant has been allocated. This is necessary so that appropriate technical support can be provided to participants, if necessary. The allocation will remain concealed to the research team coordinating the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to either myCompass or the placebo control intervention will be carried out after baseline measurement, according to a sequence generated by a computerized random-number generator using permutated blocks. The randomisation process will be facilitated by a the research platform, which will occur without researcher input.
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
Statistical analyses will be performed using SPSS and STATA. Characteristics of the two groups at baseline will be compared using chi-square tests for categorical data and t-tests for continuous data. Primary and secondary outcomes will be evaluated by intention-to-treat (ITT) analyses using a technique recommended for analysing incomplete datasets, namely, mixed models repeated measures (MMRM). Supplementary analyses will use data for completers and will also investigate whether there are any differences by recruitment source, duration of diabetes and presence of comorbid conditions. Adjustments will be made for multiple statistical testing, as appropriate.

The primary study outcome is a significant improvement in work and social functioning, measured by the Work and Social Adjustment Scale, for myCompass users at 3 months. In a previously approved study (UNSW Australia HREC10019), A/Professor Proudfoot's research team obtained an average between-group effect size (based on estimated marginal means) of d = .3 for work and social functioning. We calculated the sample size for a series of t-tests (cross-sectional comparison of arms) with alpha = 0.05 and desired power = 80%. The sample size required was N=350 (175 per arm). We cross-checked the sample size calculation using a reduction of 5 points on our secondary outcome, the Patient Health Questionnaire-9 (PHQ-9, 29), and got a similar outcome. A 5-point reduction on the PHQ-9 is considered an adequate treatment response.
Previous studies indicate attrition rates of approximately 40% in eHealth studies. As such, we will recruit 300 in each arm of the study for sufficient statistical power for completer analyses (600 in total).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290869 0
Government body
Name [1] 290869 0
National Health and Medical Research Council
Address [1] 290869 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 290869 0
Australia
Primary sponsor type
University
Name
Black Dog Institute; University of New South Wales
Address
Hospital Rd,
Prince of Wales Hospital,
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 289558 0
University
Name [1] 289558 0
University of New South Wales
Address [1] 289558 0
University of New South Wales
Sydney NSW 2052
Country [1] 289558 0
Australia
Secondary sponsor category [2] 289559 0
University
Name [2] 289559 0
University of Melbourne
Address [2] 289559 0
University of Melbourne
Parkville VIC 3010
Country [2] 289559 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292479 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 292479 0
University of New South Wales Human Research Ethics Committee
Sydney NSW 2052
Ethics committee country [1] 292479 0
Australia
Date submitted for ethics approval [1] 292479 0
26/02/2015
Approval date [1] 292479 0
14/04/2015
Ethics approval number [1] 292479 0
HC15090

Summary
Brief summary
This project will test the hypothesis that functioning and mental wellbeing will be improved in people with type 2 diabetes and comorbid depression following the use of a fully-automated mobile phone and web-based mental health intervention (‘myCompass’) for 12 weeks, compared with those who receive a placebo intervention.

Trial website
https://springboard.blackdoghealth.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55494 0
A/Prof Judy Proudfoot
Address 55494 0
Black Dog Institute
School of Psychiatry, UNSW Australia
Hospital Road
Randwick NSW 2031
Country 55494 0
Australia
Phone 55494 0
+61 2 9382 4530
Fax 55494 0
Email 55494 0
j.proudfoot@unsw.edu.au
Contact person for public queries
Name 55495 0
Dr Janine Clarke
Address 55495 0
Black Dog Institute
School of Psychiatry, UNSW Australia
Hospital Road
Randwick NSW 2031
Country 55495 0
Australia
Phone 55495 0
+61 2 9382 3719
Fax 55495 0
Email 55495 0
Janine.clarke@unsw.edu.au
Contact person for scientific queries
Name 55496 0
Dr Janine Clarke
Address 55496 0
Black Dog Institute
School of Psychiatry, UNSW Australia
Hospital Road
Randwick NSW 2031
Country 55496 0
Australia
Phone 55496 0
+61 2 9382 3719
Fax 55496 0
Email 55496 0
Janine.clarke@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results