Susanne S Pedersen1,2,3, Christina M Andersen4, Robert Ahm4, Søren J Skovbakke4, Robin Kok4, Charlotte Helmark5, Uffe K Wiil6, Thomas Schmidt6, Kim Rose Olsen7, Jacob Hjelmborg8, Ann-Dorthe Zwisler9,10, Lisbeth Frostholm11. 1. Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark. sspedersen@health.sdu.dk. 2. Department of Cardiology, Odense University Hospital, Odense, Denmark. sspedersen@health.sdu.dk. 3. Open Patient data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark. sspedersen@health.sdu.dk. 4. Department of Psychology, University of Southern Denmark, Campusvej 55, DK-5230, Odense M, Denmark. 5. Department of Cardiology, Zealand University Hospital, Roskilde, Denmark. 6. The Maersk Mc-Kinney Moller Institute, University of Southern Denmark, Odense, Denmark. 7. Danish Center for Health Economics (DaCHE), Odense University Hospital and University of Southern Denmark, Odense, Denmark. 8. Epidemiology, Biostatistics and Biodemography, University of Southern Denmark, Odense, Denmark. 9. Department of Cardiology, Odense University Hospital, Odense, Denmark. 10. Danish Knowledge Center for Rehabilitation and Palliative Care (REHPA), Odense University Hospital and University of Southern Denmark, Odense, Denmark. 11. Research Clinic for Functional Disorders and Psychosomatics, Aarhus University Hospital, Aarhus, Denmark.
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].
RCT Entities:
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].
Entities:
Keywords:
Acceptance and commitment therapy; Anxiety; Cardiac rehabilitation; Cognitive behavioral therapy; Depression; Dropout; Heart disease; Quality of life; eHealth intervention
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