Abstract
BackgroundDepression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes. In combination they lead to an even worse prognosis. Internet or web-based interventions have been shown to deliver efficacious psychological intervention programs for depression on a large scale, yet no published studies have evaluated their impact among patients with co-existing physical conditions. The aims of this randomised controlled trial are to determine the effects of an evidence-based internet intervention program for depression on depressive mood symptoms, cognitive function and treatment adherence in patients at risk of CVD.Methods/DesignThis study is an internet-based, double-blind, parallel group randomised controlled trial. The trial will compare the effectiveness of online cognitive behavioural therapy with an online attention control placebo. The trial will consist of a 12-week intervention phase with a 40-week follow-up. It will be conducted in urban and rural New South Wales, Australia and will recruit a community-based sample of adults aged 45 to 75 years. Recruitment, intervention, cognitive testing and follow-up data collection will all be internet-based and automated. The primary outcome is a change in severity of depressive symptoms from baseline to three-months. Secondary outcomes are changes in cognitive function and adherence to treatment for CVD from baseline to three, six and 12-months.DiscussionPrior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression. The potential for intervening earlier in these disease states appears to have significant potential and has yet to be tested. Scalable psychological programs using web-based interventions could deliver care to large numbers in a cost effective way if efficacy were proved. This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at risk of CVD. In addition it will also precisely and reliably define the effects of the intervention upon aspects of cognitive function that are likely to be affected early in at risk individuals, using sensitive and responsive measures.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12610000085077
Highlights
Depression, cardiovascular disease (CVD) risk factors and cognitive impairment are important causes of disability and poor health outcomes
Prior studies of depression amongst patients with CVD have targeted those with previous vascular events and major depression
This study will determine the effects of a web-based intervention on depressive symptoms and adherence to treatment among patients at risk of CVD
Summary
This trial will bring together a multidisciplinary perspective from psychiatry, cardiology, psychology, neuropsychology and neurology to study links between depression, CVD and cognitive function using a novel intervention. The trial will be one the first of its kind to evaluate the efficacy of a web-based intervention for depression in people aged 45 years and over with significant depressive symptoms who are being treated for cardiovascular risk factors This trial will target people across the range of CVD, especially those in early stage and those hard to access through usual clinical channels. It has the capacity to attract those who don’t usually seek health care services and to be delivered in areas with limited access, such as rural and remote regions This will be the first study to evaluate the effect of treating depression on early cognitive impairment, using a novel internet based assessment.
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