Short summary

MY-CHOICE is designed to fill a gap in cardiac rehabilitation, as no treatment options for anxiety and depression for patients with eschemic heart disease (IHD) who screen positive are available. The intervention is a personalized, patient-preferred and therapist-assisted e-Health intervention added to standard CR that is individually targeted to patients' needs and preferences. It targets not only depression and anxiety but also the most common challenges that patients are faced with when diagnosed with IHD, including fatigue, sleep problems, existential issues and difficulties adopting and adhering to a healthy lifestyle.

Rationale

In Denmark, every year 21.000 new patients are diagnosed with ischemic heart disease. To mitigate the impact of the disease, patients are referred to cardiac rehabilitation, a multi-disciplinary and multi-faceted effort primarily focused on physical training, patient education and risk factor management.

Cardiac rehabilitation is associated with significant cardiovascular mortality reductions even in the era of acute revascularization and improved pharmacotherapy and is a Class Ia indication in the European guidelines on cardiovascular disease prevention. To obtain these benefits, it is paramount that patients are referred, consent to participate and complete cardiac rehabilitation. Dropout rates are high with up to 50%, warranting more attention towards barriers for cardiac rehabilitation participation and adherence.

Depression, anxiety and social vulnerabilities (e.g. loneliness), comprise some of the barriers for cardiac rehabilitation, participation and adherence, with as many as one in five patients (20%) with eschemic heart disease developing depression and anxiety that warrant treatment.

In the Danish national clinical guidelines on cardiac rehabilitation, patients referred for rehabilitation are screened for depression and anxiety, but no treatment options are available except referring patients to their general practitioner (GP).

We know little about whether patients contact their GP and if they receive the appropriate treamtnet. Lack of treatment of co-morbid depression and anxiety has considerable consequences at the patient and societal level, at not only a clinical diagnosis but also subthreshold levels of depression and anxiety comprise barriers to lifestyle changes, increase risk of non-adherence, dropout from rehabilitation, hospitalization and premature death.

The purpose of MY-CHOICE is to bridge this gap in care and to develop and evaluate the efficacy and cost-effectiveness of a patient-preferred, personalized treatment for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation.

The project uses a mixed-methods three-pase design: (1) participatory design; (2) feasibility study; (3) multicenter randomized controlled trial.

The primary endpoint is change in score on anxiety and depression (HADS) at 3 months follow up.

Description of the cohort

Patients with ischemic heart disease with comorbid depression and/or anxiety.

Data and biological material

Information on demographic (e.g. gener, age, education) and clinical variables (e.g. medication, type of ischemic heart disease, previous events) and questionnaire data.

Collaborating researchers and departments

Department of Psychology, University of Southern Denmark

• Assistant Professor, PhD Christina Maar Andersen
• MSc Søren Jensen Skovbakke
• MSc Robert Ahm

Department of Epidemiology, Biostatistics, University of Southern Denmark

• Professor, PhD Jacob von Bornemann Hjelmborg

Danish Center for Health Economics (DaCHE), University of Southern Denmark

• Professor, PhD, Cand.Econ. Kim Rose Olsen

Department of Cardiology, Zealand University Hospital

• MSc Lotte Helmark

Department of Cardiology, Aarhus University Hospital

• Cardiologist, MD, PhD Helle Lynge Kansted

Research Clinic for Functional Disorders, University of Aarhus

• Associate Professor, PhD, Cand. Psych. Lisbeth Frostholm

Department of Cardiovascular Medicine, Yale School of Medicine, United States of America

• Professor, PhD Matthew Burg

Department of Psychology, Stockholm University, Sweden

• Professor, PhD Per Carlbring