Introduction We have recently showed that an app-based mental training (MT) reduces atrial fibrillation (AF) related symptoms as compared to usual care in patients undergoing catheter ablation for AF. We now report the effect of MT on health-related quality of life (HRQoL) and AF burden.

Methods MENTAL AF was a randomized clinical trial with two parallel treatment groups enrolling patients undergoing catheter ablation for symptomatic AF during August 2019 and July 2021. Patients were randomized in a 1:1-ratio to either an mobile app-based MT program or usual care with stratification for paroxysmal and persistent AF . A total of 234 patients with symptomatic AF scheduled for catheter ablation were approached of which 31 did not fulfil eligibility criteria and 19 refused study participation. The final cohort comprised 174 patients who had received catheter ablation and 151 were included in the final analysis (76 in the MT and 75 in the usual care group). The MT group gained access to a daily 10-minute app-based breathing, relaxation and meditation training, with a minimum requirement of 2 sessions/week. Both groups received regular phone calls by a study nurse. The prespecified primary outcome was the intergroup difference of the mean AF6 sum scores during the 3 months study period. The secondary outcomes were patient reported web-based, HRqOL measures life as assessed by the Atrial Fibrillation Effect on Quality of Life (AFEQT) and PROMIS Global Health as well as time in AF/atrial tachycardia as documented in 7-day Holter.

Results Baseline characteristics were well balanced between the MT vs control group, respectively: mean (SD) age 60.6 (8.7) vs 61.5 (8.7) years, female patients 42 vs 40%, paroxysmal AF 55 vs 55%, and left ventricular ejection fraction 58.0 (7.3) vs 57.5 (7.8) %. The primary outcome of AF6 sum score was 8.9 (6.9) points in the MT and 12.5 (10.1) in the usual care group (P = .011). The median difference of the AFEQT Global Score from baseline to 3 month was 18.3 (IQR 11.7 to 35) in the MT and 10.8 (IQR 1.7 to 31.7) in the usual care group (P = .026). This improvement was mainly driven by a more pronounced improvement in the daily activity domain. The PROMIS Physical Health domain improved by 4.6 (IQR 0; 7.5)  in the MT as compared to 0 (-2.6; 4.7) in the usual care group; P = .000. As for the Mental Health domain there was a trend towards a more pronounced improvement [2.9 (IQR 0 to 5.2) vs 0.8 (IQR -2.6 to 4.7); P = .061]. In the 3-month follow-up 7-day Holter 10 patients (16.9 %) in the MT vs 11 patients (14.3 %) in the usual care group exhibited AF or atrial tachycardia (P = .67) referring to a time in AF/atrial tachycardia of 479 (1863) vs. 523 (1862) minutes (P = .37). During the registration period 35 patients (53.8 %) in usual care group and 25 patients (35.7 %) in the MT group reported heart rhythm-related symptoms (P = .034).

Conclusion The MENTAL AF trial shows that an app-based body & mind intervention as an adjunctive treatment tool improves HRQoL despite an equal actual arrhythmia burden on 7-day Holter. These results suggest that mental training unfolds its effect by a modification of disease perception and coping.