A mHealth Intervention to Reduce Perceived Stress in Patients with Ischemic Heart Disease: Study Protocol for the Randomized, Controlled Confirmatory Intervention ‘mStress-IHD’ Trial

Abstract Background Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention ‘mindfulHeart’ in terms of reducing stress in patients with IHD. Methods and analysis: This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post treatment (T1) and four follow-ups at month 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), as well as the participants’ pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression and descriptive approaches will be performed for secondary analyses. Discussion The randomized controlled ‘mStress-IHD’ trial aims to assess the efficacy and cost-effectiveness of the mHealth intervention ‘mindfulHeart’ for reducing stress in patients with IHD. A successful stress reduction in IHD patients with an increase of quality of life could be an important component of secondary prevention. Thus, the investigation related to the impact of the mHealth solution ‘mindfulHeart’ can lead to beneficial findings. Ethics: The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22-11015-BO). Trial registration number: ClinicalTrials identifier NCT05846334