Abstract
BackgroundOne in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care.MethodseMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness.DiscussionTo our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as “one package” to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful.Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].
Highlights
One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety
Ischaemic heart disease (IHD) is a chronic disease, characterised by reduced blood supply to the heart due to the build-up of plaque in the coronary arteries that may lead to a heart attack – an acute myocardial infarction (AMI)
Hypotheses Given the user-centered, therapist-assisted eHealth approach to treat depression and anxiety, allowing patients to engage in the intervention when and where they want, we hypothesise that the intervention will be broadly acceptable to patients, have a low dropout rate and be effective and cost-effective
Summary
One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. 20% of patients suffer from depression, anxiety or both [3] Both a clinical diagnosis and subthreshold levels – often undetected – comprise barriers for lifestyle changes, increase risk of non-adherence, refusal or dropout from cardiac rehabilitation (CR), hospitalisation, and premature death [4,5,6]. Depression alone adds an extra cost of 33% compared to patients without depression [10] Compounding the issue, both IHD and depression are among the top contributors to the disease-burden worldwide in 2020 [2, 11, 12], warranting that we treat both the underlying somatic disease and psychological comorbidity [13]
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