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. 2021 Jan 7;21(1):20.
doi: 10.1186/s12872-020-01801-w.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol

Susanne S Pedersen  1   2   3 , Christina M Andersen  4 , Robert Ahm  4 , Søren J Skovbakke  4 , Robin Kok  4 , Charlotte Helmark  5 , Uffe K Wiil  6 , Thomas Schmidt  6 , Kim Rose Olsen  7 , Jacob Hjelmborg  8 , Ann-Dorthe Zwisler  9   10 , Lisbeth Frostholm  11
Affiliations

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol

Susanne S Pedersen et al. BMC Cardiovasc Disord. .

Abstract

Background: One 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.

Methods: eMindYourHeart 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.

Discussion: To 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].

Keywords: Acceptance and commitment therapy; Anxiety; Cardiac rehabilitation; Cognitive behavioral therapy; Depression; Dropout; Heart disease; Quality of life; eHealth intervention.

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Conflict of interest statement

Susanne S Pedersen declares that she is an Associate Editor of BMC Cardiovascular Disorders. None of the other authors have any competing interests in relation to the manuscript.

Figures

Fig. 1
Fig. 1
Trial design and flowchart of patient inclusion and follow-up
Fig. 2
Fig. 2
eMindYourHeart intervention and timeline
See this image and copyright information in PMC

References

    1. Koch MB, Johnsen NF, Davidsen M, Juel K. Hjertekarsygdomme i 2011 - incidens, prævalens og dødelighed samt udvikling siden 2002. Copenhagen: National Institute of Health; 2014.
    1. Flachs EM, Eriksen L, Koch MB, et al. Sygdomsbyrden i Danmark – sygdomme [burden of disease in Denmark - diseases]. Statens Institut for Folkesundhed, Syddansk Universitet [National Institute of health, University of Southern Denmark] Copenhagen: Danish Health Authority; 2015.
    1. Lichtman JH, Froelicher ES, Blumenthal JA, et al. Depression as a risk factor for poor prognosis among patients with acute coronary syndrome: systematic review and recommendations: a scientific statement from the American Heart Association. Circulation. 2014;129:1350–1369. doi: 10.1161/CIR.0000000000000019. - DOI - PubMed
    1. Pedersen SS, von Kanel R, Tully PJ, Denollet J. Psychosocial perspectives in cardiovascular disease. Eur J Prev Cardiol. 2017;24:108–115. doi: 10.1177/2047487317703827. - DOI - PubMed
    1. Pogosova N, Saner H, Pedersen SS, et al. Psychosocial aspects in cardiac rehabilitation: from theory to practice. A position paper from the cardiac rehabilitation section of the European Association of Cardiovascular Prevention and Rehabilitation of the European Society of Cardiology. Eur J Prev Cardiol. 2015;22:1290–1306. doi: 10.1177/2047487314543075. - DOI - PubMed

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