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Trial registered on ANZCTR


Registration number
ACTRN12613000172707
Ethics application status
Approved
Date submitted
11/01/2013
Date registered
12/02/2013
Date last updated
11/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a web- and mobile phone-based intervention for diabetes patients with depression
Scientific title
For persons with diabetes, will a web- and mobile phone-based intervention (myCompass) reduce symptoms of depression
Secondary ID [1] 281755 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 288066 0
Diabetes 288067 0
Condition category
Condition code
Mental Health 288437 288437 0 0
Depression
Metabolic and Endocrine 288438 288438 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, myCompass, is an automated self-help program available via the internet to people's desk-top computers and mobile phones. The intervention consists of real-time monitoring of symptoms with SMS prompts, therapeutic modules, fact sheets, motivational statements, mental health tips and a journal. It will be recommended that participants use myCompass for at least 1 hour per week and complete daily self-monitoring. Participants will use the full myCompass program for 7 weeks.
Intervention code [1] 286294 0
Behaviour
Intervention code [2] 286295 0
Treatment: Other
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288605 0
Mean score on Patient Health Questionnaire-9 (Kroenke et al., 2001)
Timepoint [1] 288605 0
Baseline and at 8 and 20 weeks after intervention commencement
Primary outcome [2] 288606 0
Mean score on Generalised Anxiety Disorder Assessment-7 (Sptizer et al., 2006)
Timepoint [2] 288606 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [1] 300578 0
Mean score on the Work and Social Adjustment Scale (Mundt et al., 2002)
Timepoint [1] 300578 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [2] 300579 0
Mean score on the Problem Areas in Diabetes Scale (Polonsky et al., 1995)
Timepoint [2] 300579 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [3] 300580 0
Mean score on the Mental Health Self-efficacy Scale (Clarke et al., Manuscript in preparation)
Timepoint [3] 300580 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [4] 300581 0
Mean score on the Diabetes Self-efficacy Scale (Lorig, unpublished manuscript)
Timepoint [4] 300581 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [5] 300582 0
Mean score on the Measure of Mental Anticipatory Processes (Feldman and Hayes, 2005)
Timepoint [5] 300582 0
Baseline and at 8 and 20 weeks after intervention commencment
Secondary outcome [6] 300583 0
Diabetes self-management as reported on the Diabetes Self-management Scale (Toobert et al., 2000)
Timepoint [6] 300583 0
Baseline and at 8 and 20 weeks after intervention commencement
Secondary outcome [7] 300584 0
Mean scores on the Hyperglycemia/Hypoglycemia scales (Piette et al., 1999)
Timepoint [7] 300584 0
Baseline and at 8 and 20 weeks after intervention commencement

Eligibility
Key inclusion criteria
To be eligible, participants must:
- have type 1 or type 2 diabetes, diagnosed by a GP or endocrinologist
- have no previous experience with the myCompass program
- be 18 - 75 years of age
- be literate in English
- have access to a computer, the internet and a valid email address
- have access to an internet enabled mobile phone
- be experiencing at least mild depression
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychosis (as measured by the Psychosis Screening Questionnaire, Bebbington, 1995)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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] 286541 0
Charities/Societies/Foundations
Name [1] 286541 0
Black Dog Institute
Address [1] 286541 0
Hospital Road
Randwick NSW 2031
Country [1] 286541 0
Australia
Primary sponsor type
Individual
Name
A/Professor Judy Proudfoot
Address
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 285328 0
Individual
Name [1] 285328 0
Dr Janine Clarke
Address [1] 285328 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country [1] 285328 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288610 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 288610 0
Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building
Level 3, South Wing
The University of New South Wales
Sydney NSW 2052
Ethics committee country [1] 288610 0
Australia
Date submitted for ethics approval [1] 288610 0
23/11/2012
Approval date [1] 288610 0
16/01/2013
Ethics approval number [1] 288610 0
HREC12616

Summary
Brief summary
Depression is a common mental health problem in people with diabetes and is associated with lower quality of life, poorer blood glucose control, and higher rates of functional disability, diabetes related complications and mortality. The internet is recognised increasingly as a useful way of increasing public access to evidence-based treatments for mental health problems. In a recent study, researchers at the Black Dog Institute showed that a new internet and mobile phone intervention, 'myCompass', improved significantly mental health outcomes for people with mild to moderate depression, stress and anxiety. The proposed study will examine whether use of myCompass improves mental health outcomes in people with diabetes, and is associated with improved self-managment and blood glucose control.
Trial website
Trial related presentations / publications
Clarke J, Proudfoot J, Ma H. Mobile Phone and Web-based Cognitive Behavior Therapy for Depressive Symptoms and Mental Health Comorbidities in People Living With Diabetes: Results of a Feasibility Study JMIR Ment Health 2016;3(2):e23
Public notes

Contacts
Principal investigator
Name 36946 0
A/Prof Judy Proudfoot
Address 36946 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 36946 0
Australia
Phone 36946 0
+61 2 9382 3767
Fax 36946 0
Email 36946 0
j.proudfoot@unsw.edu.au
Contact person for public queries
Name 36947 0
Dr Janine Clarke
Address 36947 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 36947 0
Australia
Phone 36947 0
+61 2 9382 3719
Fax 36947 0
Email 36947 0
janine.clarke@unsw.edu.au
Contact person for scientific queries
Name 36948 0
A/Prof Judy Proudfoot
Address 36948 0
Black Dog Institute
Hospital Road
Randwick NSW 2031
Country 36948 0
Australia
Phone 36948 0
+61 2 9382 3767
Fax 36948 0
Email 36948 0
J.proudfoot@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary