ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12610000085077

Ethics application status

Approved

Date submitted

21/01/2010

Date registered

25/01/2010

Date last updated

26/02/2014

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]

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

Cardiovascular Disease

Cognitive function

Condition category

Condition code

Mental Health

Depression

Cardiovascular

Coronary heart disease

Mental Health

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]

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]

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]

Changes will be measured from baseline to 3 months (post-intervention).

Secondary outcome [1]

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]

Changes in cognitive function will be measured from baseline to 3 months (post-intervention), 6 months and 12 months.

Secondary outcome [2]

Changes in adherence to treatment for cardiovascular disease, using the Medical Outcomes Study Measures of Patient Adherence Scale.

Timepoint [2]

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

Sex

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

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

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2010

Actual

27/07/2010

Date of last participant enrolment

Anticipated

Actual

4/01/2011

Date of last data collection

Anticipated

Actual

Sample size

Target

500

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The National Heart Foundation of Australia

Address [1]

Level 12, 500 Collins St
Melbourne VIC 3000

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

beyondblue: the national depression initiative

Address [2]

PO Box 6100
Hawthorn West VIC 3122

Country [2]

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]

University

Name [1]

The Australian National University

Address [1]

Centre for Mental Health Research
Building 63, Eggleston Road
Canberra ACT 0200

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Sydney Human Research Ethics Committee

Ethics committee address [1]

Research Office
Level 6, Jane Foss Russell Building G02
The University of Sydney NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/06/2009

Approval date [1]

30/06/2009

Ethics approval number [1]

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

Prof Ian Hickie

Address

Brain & Mind Research Institute
100 Mallett Street
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9351 0810

Fax

ian.hickie@sydney.edu.au

Contact person for public queries

Name

Nicole Cockayne

Address

Brain and Mind Research Institute
100 Mallet Street
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9351 0830

Fax

nicole.cockayne@sydney.edu.au

Contact person for scientific queries

Name

Nick Glozier

Address

Brain and Mind Research Institute
100 Mallet Street
Camperdown NSW 2050

Country

Australia

Phone

+61 2 9351 0536

Fax

nick.glozier@sydney.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Internet-based treatment for older adults with depression and co-morbid cardiovascular disease: Protocol for a randomised, double-blind, placebo controlled trial.	2011	https://dx.doi.org/10.1186/1471-244X-11-10
Embase	Motivators and motivations to persist with online psychological interventions: a qualitative study of treatment completers.	2012	https://dx.doi.org/10.2196/jmir.2100
Embase	The relationship between depression and cognitive function in adults with cardiovascular risk: Evidence from a randomised attention-controlled trial.	2018	https://dx.doi.org/10.1371/journal.pone.0203343

N.B. These documents automatically identified may not have been verified by the study sponsor.

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