Trial from ANZCTR


Trial ID ACTRN12610000085077
Trial Status: Registered
Date Submitted: 21/01/2010
Date Registered: 25/01/2010
Prospectively registered

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Public title The CREDO Research Project: Can mood problems be prevented and treated using e-health interventions in patients being treated for cardiovascular disease?
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format A randomised controlled trial of a web-based intervention to improve mood, cognitive function and adherence in people with co-morbid cardiovascular disease
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Secondary ID [1] 1329 0
Nil
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UTN U1111-1113-4440
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Trial acronym The CREDO Research Project
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Health condition(s) or problem(s) studied:
Depression 256641 0
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Cardiovascular Disease 256645 0
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Cognitive function 256647 0
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Condition category: Condition code:
Mental Health Depression
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256803 256803 0 0
Cardiovascular Coronary heart disease
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256806 256806 0 0
Mental Health Studies of normal psychology, cognitive function and behaviour
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256807 256807 0 0

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Descriptions 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.
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Intervention Code:
Treatment: Other 255879 0
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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.
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Control group Active
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Primary Outcome: 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. 257668 0
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Timepoint: Changes will be measured from baseline to 3 months (post-intervention). 257668 0
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Secondary Outcome: 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. 262974 0
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Timepoint: Changes in cognitive function will be measured from baseline to 3 months (post-intervention), 6 months and 12 months. 262974 0
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Secondary Outcome: Changes in adherence to treatment for cardiovascular disease, using the Medical Outcomes Study Measures of Patient Adherence Scale. 262975 0
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Timepoint: Changes in adherence to treatment for cardiovascular disease will be measured from baseline to 3 months (post-intervention), 6 months and 12 months. 262975 0
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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.
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Minimum age 45 Years
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Maximum age 75 Years
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features The study is internet-based.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/06/2010
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Date of first participant enrolment 27/07/2010
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled 4/01/2011
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Target sample size 500
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Recruitment status Closed: follow-up complete
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 256365 0
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Name: The National Heart Foundation of Australia 256365 0
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Address: Level 12, 500 Collins St
Melbourne VIC 3000
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Country: Australia 256365 0
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Funding Source: Charities/Societies/Foundations 256366 0
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Name: beyondblue: the national depression initiative 256366 0
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Address: PO Box 6100
Hawthorn West VIC 3122
256366 0
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Country: Australia 256366 0
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Primary Sponsor University
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Name: The University of Sydney
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Address: Brain and Mind Research Institute
100 Mallet St
Camperdown NSW 2050
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Country: Australia
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Secondary Sponsor: University 251683 0
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Name: The Australian National University 251683 0
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Address: Centre for Mental Health Research
Building 63, Eggleston Road
Canberra ACT 0200
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Country: Australia 251683 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Sydney Human Research Ethics Committee 258436 0
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Address: Research Office
Level 6, Jane Foss Russell Building G02
The University of Sydney NSW 2006
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Country: Australia 258436 0
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Approval Date: 30/06/2009 258436 0
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Submitted Date: 22/06/2009 258436 0
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HREC: 11880 258436 0
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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.
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Trial website www.sydney.edu.au/bmri
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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.
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Public Notes
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Principal Investigator
Title: Prof
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Name: Ian Hickie
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Address: Brain & Mind Research Institute 100 Mallett Street Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9351 0810
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Email: ian.hickie@sydney.edu.au
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Contact person for public queries
Title: Ms
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Name: Nicole Cockayne
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Address: Brain and Mind Research Institute 100 Mallet Street Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9351 0830
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Email: nicole.cockayne@sydney.edu.au
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Contact person for scientific queries
Title: Prof
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Name: Nick Glozier
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Address: Brain and Mind Research Institute 100 Mallet Street Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9351 0536
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Email: nick.glozier@sydney.edu.au
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Contact person responsible for updating information
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Name: Nicole Cockayne
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Address: Brain and Mind Research Institute 100 Mallet Street Camperdown NSW 2050
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Country: Australia
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Tel: +61 2 9351 0830
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Email: nicole.cockayne@sydney.edu.au
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Addition Cancer fields
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