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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
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?
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
Secondary ID 1329 0
Universal Trial Number (UTN)
Trial acronym
The CREDO Research Project

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
Cardiovascular 256806 256806 0 0
Coronary heart disease
Mental Health 256807 256807 0 0
Studies of normal psychology, cognitive function and behaviour

Study type
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 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

Primary outcome 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 257668 0
Changes will be measured from baseline to 3 months (post-intervention).
Secondary outcome 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 262974 0
Changes in cognitive function will be measured from baseline to 3 months (post-intervention), 6 months and 12 months.
Secondary outcome 262975 0
Changes in adherence to treatment for cardiovascular disease, using the Medical Outcomes Study Measures of Patient Adherence Scale.
Timepoint 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.

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
The study is internet-based.
Not Applicable
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Closed: follow-up complete
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
Ethics committee name 258436 0
University of Sydney Human Research Ethics Committee
Ethics committee address 258436 0
Research Office
Level 6, Jane Foss Russell Building G02
The University of Sydney NSW 2006
Ethics committee country 258436 0
Date submitted for ethics approval 258436 0
Approval date 258436 0
Ethics approval number 258436 0

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
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

Principal investigator
Name 30741 0
Prof Ian Hickie
Address 30741 0
Brain & Mind Research Institute
100 Mallett Street
Camperdown NSW 2050
Country 30741 0
Phone 30741 0
+61 2 9351 0810
Fax 30741 0
Email 30741 0
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
Phone 13988 0
+61 2 9351 0830
Fax 13988 0
Email 13988 0
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
Phone 4916 0
+61 2 9351 0536
Fax 4916 0
Email 4916 0