Online Mindfulness-Based Intervention (eMBI) in management of dyspnea in patients with interstitial lung disease: A randomized clinical trial.

Rationale: Dyspnea and cough are frequent symptoms in ILD patients. The management of these symptoms is challenging, and evidence-based therapies are lacking.

Objectives: To evaluate the effect of an online Mindfulness-Based Intervention (eMBI) on reducing dyspnea in patients affected by different ILDs.

Methods: This study was a prospective, open-label, controlled trial that included patients ≥18 years and a modified Medical Research Council (mMRC) dyspnea scale score of ≥ 1. Patients were randomized into either the eMBI or the control group (CG) for 8 weeks. The primary outcome was the change in the dyspnea mMRC scale. The Leicester Cough Questionnaire (LCQ), King's Brief Interstitial Lung Disease (K-BILD) questionnaire, and Depression, Anxiety, and Stress Scale (DASS-21) were performed before and after the eight weeks. All analyses were conducted on an intention-to-treat basis. The study was registered at the Brazilian Registry of Clinical Trials (ReBEC), RBR-3s4mf9y.

Results: 24 patients in the eMBI and 25 in the CG completed the intervention. In the eMBI group, compared to the control group, there was a greater proportion of patients with a reduction in dyspnea according to the mMRC scale score (48.9 % versus, 15.4 %, p = 0.001). There was no significant difference between the groups in the LCQ (p = 0.666), or in the K-BILD (p = 0.108), depression (p = 0.08), or anxiety (p = 0.869 or stress (p = 0.789). No moderate or severe adverse events were observed in either group.

Conclusions: Eight weeks eMBI is a potentially viable and safe approach, that can help manage dyspnea in ILD patients.