The ‘PreventiPlaque’ randomized controlled trial: Psychological influences on the efficacy of a mHealth intervention for cardiovascular risk reduction (Preprint)

BACKGROUND Atherosclerotic cardiovascular diseases (ACD) are the leading global cause of disease and mortality. Since secondary prevention targets key modifiable risk factors, addressing mental health is essential, as impaired mental health increases cardiovascular risk and reduces treatment adherence. The personalized mHealth intervention ‘PreventiPlaque’ demonstrated its efficacy in improving cardiovascular and secondary risk factors in patients with ACD. OBJECTIVE This analysis of the ‘PreventiPlaque’ randomized controlled trial (RCT) investigates psychological factors influencing the app’s efficacy in cardiovascular risk reduction and the intervention’s effects on psychological well-being. METHODS This analysis of the two-arm ‘PreventiPlaque’ RCT (intervention vs. treatment as usual) included N = 240 patients with ACD (intervention group: n = 119, controls: n = 121). Psychological factors included depression, anxiety symptoms, distress, subjective physical well-being, and sense of positive and negative agency. Cardiovascular risk profile was assessed according to Systematic Coronary Risk Evaluation (SCORE2). Statistical analysis utilized linear mixed effects models and repeated measure ANOVAs (within-between). RESULTS Linear mixed effects models revealed no relevant psychological moderators of the intervention’s effect on the cardiovascular risk profile (p > .05). The intervention did not significantly improve psychological outcomes (p > .05), except for a stabilization of subjective physical well-being in the intervention group (p = .027). CONCLUSIONS ‘PreventiPlaque’s efficacy was largely independent of psychological factors, suggesting the mHealth intervention is robust and accessible even for more patients affected by mental health issues. The app successfully stabilized subjective physical well-being which declined in the control group over time. CLINICALTRIAL The study was registered at ClinicalTrials.gov under the identifier NCT05096637 on 27 October 2021.