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Trial registered on ANZCTR


Trial ID
ACTRN12610000085077
Ethics application status
Approved
Date submitted
21/01/2010
Date registered
25/01/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The CREDO Research Project: Can mood problems be prevented and treated using e-health interventions in patients being treated for cardiovascular disease?
Scientific title
A randomised controlled trial of a web-based intervention to improve mood, cognitive function and adherence in people with co-morbid cardiovascular disease
Secondary ID [1] 1329 0
Nil
Universal Trial Number (UTN)
U1111-1113-4440
Trial acronym
The CREDO Research Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 256641 0
Cardiovascular Disease 256645 0
Cognitive function 256647 0
Condition category
Condition code
Mental Health 256803 256803 0 0
Depression
Cardiovascular 256806 256806 0 0
Coronary heart disease
Mental Health 256807 256807 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention of interest for this study is e-couch for depression, a 12-week, online, multimedia application that provides mental health literacy (e.g. what causes mood problems, how to prevent them and how to treat them) and a set of online evidence-based cognitive behavioural therapy interventions designed to equip the user with strategies to improve their mood and emotional state, along with a workbook to track progress and record experiences. Participants will be asked to visit e-couch to complete a module once a week (spending approximately 30 minutes to an hour) for twelve weeks.
Intervention code [1] 255879 0
Treatment: Other
Comparator / control treatment
Participants assigned to the control treatment will interact with a specially designed HealthWatch website which requires them to read about different health topics each week over 12 weeks. Topics include: environmental health; nutrition; a healthy heart; energise yourself and your family; medicines in your home; temperature extremes; oral health; blood pressure and cholesterol; calcium and backpain. In addition, participants complete online questionnaires that probe: health factors; physical and artistic activities; education and hobbies; social, financial and family roles; work habits and stress; medications; pain; nutrition; and alcohol use. Participants will be asked to visit HealthWatch to complete a module and the associated questionnaire once a week (spending approximately 30 minutes to an hour) for twelve weeks.
Control group
Active

Outcomes
Primary outcome [1] 257668 0
A change in severity of depressive symptoms, as measured using the Patient Health Questionnaire (PHQ-9). This 9-item assessment tool, designed for community samples, provides a summary score ranging from 0 to 27. Participants meeting the cut point on the PHQ-9 depression score suggestive of more than moderate (greater than 9) results will be considered positive as having depressive symptoms.
Timepoint [1] 257668 0
Changes will be measured from baseline to 3 months (post-intervention).
Secondary outcome [1] 262974 0
Changes in cognitive function, as measured using internet deliverable computerised cognitive tasks (CogState) with well established validity and sensitivity to slowing of psychomotor function and impairment of attention, working memory and new learning abilities.
Timepoint [1] 262974 0
Changes in cognitive function will be measured from baseline to 3 months (post-intervention), 6 months and 12 months.
Secondary outcome [2] 262975 0
Changes in adherence to treatment for cardiovascular disease, using the Medical Outcomes Study Measures of Patient Adherence Scale.
Timepoint [2] 262975 0
Changes in adherence to treatment for cardiovascular disease will be measured from baseline to 3 months (post-intervention), 6 months and 12 months.

Eligibility
Key inclusion criteria
1. Participant in the logitudinal cohort, the 45 and Up Study
2. Aged 45 to 75 years at date of sampling
3. Self-reported history of cardiovascular disease as collected within the 45 and Up Study baseline data
4. Positive screen for depressive symptoms as collected within the baseline 45 and Up Study data
5. Provided informed consent to participate and link their data with that of Medicare Australia and NSW Health Services.
Minimum age
45 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will be applied at the time of screening entry to the trial as follows: 1. No depressive symptoms, as determined using the PHQ-9 (scores less than or equal to 7 on the 27-point scale). 2. Suicidal ideation determined from the PHQ-9. 3. Current psychotherapy of any form.

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 automatically randomised upon completion of the online consent, eligibility screening and baseline assessment phase. Allocation concealment will be achieved using a customised randomisation facility. The fully itemised procedure allows for full replication and can accommodate stratification and specification of block sizes. The randomisation facility will be built into the internet programme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using the computer software built into the internet programme. Randomisation will be stratified by depressive symptom severity in blocks. Symptom severity will be determined using PHQ-9 scores, where scores 14 or less will be classified as low, indicating minor depression, and scores ranging from 15 to 27 will be classified as high, indicating major depression.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The study is internet-based.
Phase
Not Applicable
Type of endpoint(s)
Efficacy

Recruitment
Recruitment status
Completed
Anticipated date of first participant enrolment
1/06/2010
Actual date of first participant enrolment
27/07/2010
Anticipated date last participant enrolled
Actual date last participant enrolled
4/01/2011
Anticipated date of last data collection
Actual date of last data collection
Target sample size
500
Actual sample size
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256365 0
Charities/Societies/Foundations
Name [1] 256365 0
The National Heart Foundation of Australia
Address [1] 256365 0
Level 12, 500 Collins St
Melbourne VIC 3000
Country [1] 256365 0
Australia
Funding source category [2] 256366 0
Charities/Societies/Foundations
Name [2] 256366 0
beyondblue: the national depression initiative
Address [2] 256366 0
PO Box 6100
Hawthorn West VIC 3122
Country [2] 256366 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Brain and Mind Research Institute
100 Mallet St
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 251683 0
University
Name [1] 251683 0
The Australian National University
Address [1] 251683 0
Centre for Mental Health Research
Building 63, Eggleston Road
Canberra ACT 0200
Country [1] 251683 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258436 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 258436 0
Research Office
Level 6, Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country [1] 258436 0
Australia
Date submitted for ethics approval [1] 258436 0
22/06/2009
Approval date [1] 258436 0
30/06/2009
Ethics approval number [1] 258436 0
11880

Summary
Brief summary
Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are key causes of disability and poor health outcomes. Comorbidity of these leads to an even worse prognosis. The primary aim of this randomised controlled trial is to determine the effect of an evidence-based internet intervention program for depression on depressive mood symptoms in patients being treated for, or at risk of developing, CVD. Participants will be drawn from the longitudinal cohort study of healthy volunteers, the 45 and Up Study. Participants will be selected on the basis of self-reported history of CVD or multiple risk-factors for developing CVD and positive screen for depressive symptoms, as measured by the Kessler-10.

The 12 week intervention will compare the effectiveness of online cognitive behavioural therapy (e-couch) with an attention control placebo (HealthWatch website). Follow-up will occur post-intervention and again at 6 and 12 months. Therefore, secondary aims of this trial are to determine the immediate and 12 month efficacy of the internet intervention on cognitive function and adherence to cardiovascular treatment and exercise.
Trial website
www.sydney.edu.au/bmri
Trial related presentations / publications
1. Cockayne NL, Glozier N, Naismith SL, Christensen H, Neal B, Hickie IB. Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: protocol for a randomised, double-blind, placebo controlled trial. BMC Psychiatry, 2011; 11(1):10.

2. Glozier N, Christensen H, Naismith S, Cockayne N, Donkin L, Neal B, Mackinnon A, Hickie IB. (2013) Internet-Delivered Cognitive Behavioural Therapy for Adults with Mild to Moderate Depression and High Cardiovascular Disease Risks: A Randomised Attention-Controlled Trial. PLoS ONE 8(3): e59139.
Public notes

Contacts
Principal investigator
Name 30741 0
Prof Ian Hickie
Address 30741 0
Brain & Mind Research Institute
100 Mallett Street
Camperdown NSW 2050
Country 30741 0
Australia
Phone 30741 0
+61 2 9351 0810
Fax 30741 0
Email 30741 0
ian.hickie@sydney.edu.au
Contact person for public queries
Name 13988 0
Ms Nicole Cockayne
Address 13988 0
Brain and Mind Research Institute
100 Mallet Street
Camperdown NSW 2050
Country 13988 0
Australia
Phone 13988 0
+61 2 9351 0830
Fax 13988 0
Email 13988 0
nicole.cockayne@sydney.edu.au
Contact person for scientific queries
Name 4916 0
Prof Nick Glozier
Address 4916 0
Brain and Mind Research Institute
100 Mallet Street
Camperdown NSW 2050
Country 4916 0
Australia
Phone 4916 0
+61 2 9351 0536
Fax 4916 0
Email 4916 0
nick.glozier@sydney.edu.au