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Discussion
The findings of this 1-year prospective observational pilot study support the feasibility and safety of an MBSR program in patients affected by ILDs. Feasibility needed to be established, since one of the main practices of MBSR involves paying attention to breathing, which potentially could increase stress in these patients. The dropout rate was low (10.5%), with two patients withdrawing from the study during the preintervention observational period, as they felt unable to attend the MBSR program regularly. All 17 patients who entered the program managed to complete the study, attending an average of eight meetings of the nine scheduled. This high completion rate is particularly pertinent as many patients had to travel (in some cases, they lived hundreds of kilometres away) and the intervention was held in winter, between January and March, and patients had to face bad weather. Although adherence to homework was not recorded (see limitations of the study below), during the 2 months program and in the follow-up period a regular daily home practice of 30–45 min was informally reported by 2/3 of the patients; 1/3 of patients admitted being less regular with home exercises.
We believe that the reasons for the good adherence to such a new approach are several. First, the setting chosen for the MBSR program was a conference room located in the Clinic for Respiratory Diseases, a familiar place for the patients. As such, the proximity to a well-known secure environment and to the familiar and trusted medical staff (although no doctors were admitted to take part in the MBSR sessions) might have worked as a facilitating factor. Second, the paucity of treatment options for many ILDs may have encouraged these greatly motivated patients to search for new approaches of care to improve their performances and quality of life. Third, feelings of loneliness and abandonment are often present in patients with rare diseases, and sharing such an experience with people affected by the same health problems, as with dedicated support groups, may be helpful. In fact, MBSR could represent a complementary strategy for developing new potential synergies and forming peer groups, as well as for helping patients acquire self-awareness and feel more empowered. Furthermore, the supportive role and empathy with the mindfulness instructor may act as a non-specific factor improving program adherence and outcomes.
The results obtained from the questionnaires on mood and perceived stress showed a potential efficacy of the MBSR program in improving the emotional status in these patients.
The improvements in the POMS and PSS questionnaires throughout the 1-year follow-up suggests that the application of mindfulness techniques may play a role in helping patients to reduce mood disturbance and in adjusting better to their incurable disease. The mechanism of action of mindfulness is obviously different from 're-framing' in which thoughts are challenged and restructured. The shift of perspective, named 're-perceiving', is a more reliable mechanism. However, there might be another way how mindfulness can work, as we observed in patients an increased capacity to stay exposed to simple and preordained mental life, disrupting the strenuous process of holding on themselves and their world. This attitude of 'bearing the void' has a curious, committed approach; it is effectively sustained by deep yoga practice, that allow to listen physical sensations in a new interesting way, not confirming usual mindsets.
It is noticeable that the improvement of mood had a constant trend over time (figure 2) right after the end of the intervention period. In this period, we recorded from many patients' statements about the attractiveness of the method and their regular practice—developed in a personal blend of meditation, yoga, body scan and informal exercises. Therefore, it is possible that the follow-up periodical meetings worked as a booster for the patients' will in pursuing their home practice. It is not possible, though, to exclude some positive seasonal influence on the mood acting as a confounding factor, as the postintervention observational period covered the whole spring and summer, potentially bearing a more positive attitude.
The positive trend in the emotive sphere was not reflected by changes in respiratory symptoms of these patients, as measured by the Shortness of Breath and the CASA-Q questionnaires. Lung function and exercise tolerance were also unaffected. This discrepancy was not unexpected, however. The respiratory questionnaires focused on the ability of patients to perform daily life activities that become limited as the disease progresses, specifically dyspnoea and cough. It would be surprising if an intervention aimed at modifying the perception of a symptom had such an effect that could even alter the symptom itself and hence improve physical performances. Indeed, it has to be pointed out that there was no significant change in respiratory symptoms over the study period, which should be considered as a positive outcome in a 12-month follow-up study including patients with progressive respiratory diseases.
This pilot study has several limitations. First of all, the sample size of the study population is small. For the POMS and the PSS tests, we performed the analysis across different time points. Although the overall change in scores between the beginning and the end of the observation period is consistent, the adoption of multiple testing carries a potential risk of generating false positives. This issue might be addressed by larger studies. ILDs are rare conditions, though, and the program itself was designed for small groups. As such, future research requires international multicentre populations. The advantage of exploring the effect of the MBSR program in people belonging to different cultural and social settings would add significant strength to the results.
Second, assessment of mood or stress is very challenging and sensible to the influence of many confounding factors: age, comorbidities (physical or psychological) and external factors (such as seasonality) can easily affect the perception of mood states and symptoms. Hence, the adoption of a properly matched control arm and randomisation would be needed to determine the real efficacy of the MBSR program in the emotional field.
Another limitation is represented by the substantial heterogeneity of the population recruited into the study in terms of disease severity and diagnosis, although the majority of patients (63%) were affected by IPF. Again, this limitation is strictly related to the single-centre design of the study, and larger randomised and possibly multicentre studies would allow a proper stratification of patients in order to seek how this approach can impact different stages of severity in specific conditions.
Finally, in this pilot study, adherence to homework was not rigorously recorded in diaries, usually adopted for recording mindfulness practice at home. This was done in order to not apply pressure on patients with breathing difficulties. Moreover, the sample size was too small for making adequate comparisons between more and less compliant patients. Indeed, measures to monitor the adherence of participants to daily home exercises should be adopted in confirmatory studies in order to state with certainty whether pursuing mindfulness practice after the end of the program results in a consistent, long-lasting effect.
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