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Trial Review
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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
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Scientific title
For persons with diabetes, will a web- and mobile phone-based intervention (myCompass) reduce symptoms of depression
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Secondary ID [1]
281755
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depression
288066
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Diabetes
288067
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Condition category
Condition code
Mental Health
288437
288437
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0
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Depression
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Metabolic and Endocrine
288438
288438
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286294
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Behaviour
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Intervention code [2]
286295
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Treatment: Other
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Mean score on Patient Health Questionnaire-9 (Kroenke et al., 2001)
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Assessment method [1]
288605
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Timepoint [1]
288605
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Baseline and at 8 and 20 weeks after intervention commencement
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Primary outcome [2]
288606
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Mean score on Generalised Anxiety Disorder Assessment-7 (Sptizer et al., 2006)
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Assessment method [2]
288606
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Timepoint [2]
288606
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [1]
300578
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Mean score on the Work and Social Adjustment Scale (Mundt et al., 2002)
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Assessment method [1]
300578
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Timepoint [1]
300578
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [2]
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Mean score on the Problem Areas in Diabetes Scale (Polonsky et al., 1995)
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Assessment method [2]
300579
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Timepoint [2]
300579
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [3]
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Mean score on the Mental Health Self-efficacy Scale (Clarke et al., Manuscript in preparation)
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Assessment method [3]
300580
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Timepoint [3]
300580
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [4]
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Mean score on the Diabetes Self-efficacy Scale (Lorig, unpublished manuscript)
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Assessment method [4]
300581
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Timepoint [4]
300581
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [5]
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Mean score on the Measure of Mental Anticipatory Processes (Feldman and Hayes, 2005)
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Assessment method [5]
300582
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Timepoint [5]
300582
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Baseline and at 8 and 20 weeks after intervention commencment
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Secondary outcome [6]
300583
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Diabetes self-management as reported on the Diabetes Self-management Scale (Toobert et al., 2000)
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Assessment method [6]
300583
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Timepoint [6]
300583
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Baseline and at 8 and 20 weeks after intervention commencement
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Secondary outcome [7]
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Mean scores on the Hyperglycemia/Hypoglycemia scales (Piette et al., 1999)
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Assessment method [7]
300584
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Timepoint [7]
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Baseline and at 8 and 20 weeks after intervention commencement
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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
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Psychosis (as measured by the Psychosis Screening Questionnaire, Bebbington, 1995)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/03/2013
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Actual
25/06/2013
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Date of last participant enrolment
Anticipated
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Actual
27/10/2013
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Date of last data collection
Anticipated
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Actual
1/03/2014
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Sample size
Target
200
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Accrual to date
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Final
92
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
286541
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Charities/Societies/Foundations
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Name [1]
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Black Dog Institute
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Address [1]
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Hospital Road
Randwick NSW 2031
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Country [1]
286541
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Australia
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Primary sponsor type
Individual
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Name
A/Professor Judy Proudfoot
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Address
Black Dog Institute
Hospital Road
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
285328
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Individual
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Name [1]
285328
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Dr Janine Clarke
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Address [1]
285328
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Black Dog Institute
Hospital Road
Randwick NSW 2031
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Country [1]
285328
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288610
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University of New South Wales Human Research Ethics Committee
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Ethics committee address [1]
288610
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Ethics Secretariat
UNSW Grants Management Office
Rupert Myers Building
Level 3, South Wing
The University of New South Wales
Sydney NSW 2052
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Ethics committee country [1]
288610
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Australia
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Date submitted for ethics approval [1]
288610
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23/11/2012
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Approval date [1]
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16/01/2013
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Ethics approval number [1]
288610
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HREC12616
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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.
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Trial website
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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
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Public notes
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Contacts
Principal investigator
Name
36946
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A/Prof Judy Proudfoot
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Address
36946
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Black Dog Institute
Hospital Road
Randwick NSW 2031
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Country
36946
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Australia
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Phone
36946
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+61 2 9382 3767
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Fax
36946
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Email
36946
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[email protected]
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Contact person for public queries
Name
36947
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Dr Janine Clarke
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Address
36947
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Black Dog Institute
Hospital Road
Randwick NSW 2031
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Country
36947
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Australia
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Phone
36947
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+61 2 9382 3719
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Fax
36947
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Email
36947
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[email protected]
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Contact person for scientific queries
Name
36948
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A/Prof Judy Proudfoot
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Address
36948
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Black Dog Institute
Hospital Road
Randwick NSW 2031
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Country
36948
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Australia
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Phone
36948
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+61 2 9382 3767
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Fax
36948
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Email
36948
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[email protected]
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No information has been provided regarding IPD availability
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.
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