Health & Medical Respiratory Diseases

Mindfulness-based Stress Reduction in Interstitial Lung Diseases

´╗┐Mindfulness-based Stress Reduction in Interstitial Lung Diseases

Methods

Study Population and Design


Nineteen adult patients were recruited between November and December 2012 at the Centre for Rare Lung Diseases of the University Hospital of Modena, Italy. Inclusion criteria included a confirmed diagnosis of ILD according to international guidelines. Exclusion criteria were the inability to express a valid consent, the inability to perform pulmonary function tests, the use of long-term oxygen therapy for more than 18 h/day and the regular practice of meditation or Yoga, as the study was meant to evaluate the efficacy of mindfulness-based practice including meditation and Hatha Yoga techniques introduced for the first time. Patients of all levels of disease were included, as the purpose of the study was to evaluate for the first time the feasibility of an MBSR program in a heterogeneous sample of patients with ILD. We conducted a prospective, observational study with a duration of 1 year, comprising three phases: a preintervention observational period (2 months), an intervention period (2 months) during which patients were trained in the MBSR program, and a postintervention observational period (8 months; figure 1).



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Figure 1.



Study design.
SOB, Shortness Of Breath questionnaire; CASA-Q, Cough And Sputum Assessment Questionnaire; POMS, Profile Of Mood State test; PSS, Perceived Stress Scale; PFT, pulmonary function test; 6MWT, 6 min walk test; MBSR, Mindfulness Based Stress Reduction program.




Ethics and Recruitment


The conduct of the study was approved by the Ethics Committee of Modena, Italy. Twenty-five patients followed up at the Centre for Rare Lung Diseases of the University Hospital of Modena were invited to take part and provided with a participant information sheet. An orientation meeting was also held in order to introduce candidates to the basic concepts of mindfulness and give information about the MBSR program. Written informed consent was collected from all patients who decided to participate. Overall, six patients declined participation, mainly due to the practical difficulties they would have encountered in attending the MBSR program (many patients lived far away from the centre).

MSBR Program


The program was conducted by an MBSR instructor with a personal history of 20 years of supervised meditation practice and who was specifically trained for 2 years in mindfulness methods at the University of Florence (Italy). It was divided into eight weekly meetings of 150 min each, to which all the patients were invited to join as a single group. Meetings were held in a comfortable quiet room located inside the hospital building. Three different techniques were taught in sequence: body scan focusing on sensations from different parts of the body, with verbal reminders from the instructor to focus on abdominal breathing; sitting meditation on a chair with a straight back, bringing not judgemental awareness of natural breath and on mental events; light yoga based on instruction in simple body movements and postures with controlled breathing. Instructions were given to patients to continue performing exercises daily at home for 45 min between the weekly meetings and after the training programme was completed; patients were also provided with CDs as a guide for home practice. An all-day meeting of 7 h between the sixth and the seventh session completed the course. Overall, the instructor total contact time was 28 h in 8 weeks.

At the end of the program, patients were asked to continue practising alone at home every day. To support patients' home practice, three quarterly group meetings of 150 min each were added during the postintervention observational period.

Outcome Measures


The primary outcomes of the study were safety, measured as the frequency of adverse events related to the practice of mindfulness techniques, and feasibility, measured as the rate of dropouts and adherence to the MBSR program. Other outcomes included changes in mood, perceived stress and respiratory symptoms (measured by patient-reported outcomes-questionnaires), change in lung function (assessed by the rate of relative change from baseline in forced vital capacity (FVC, % predicted), and rate of change in Single Breath-Diffusion Lung Capacity of Carbon Oxide (SB-DLCO) and change in exercise tolerance measured as changes in the 6 min walking test (6MWT).

The Profile Of Mood State (POMS) test, measuring the improvement of mood, consists of 40 items clustered into 6 scales (anger, confusion, depression, fatigue, tension, Vigour). The Perceived Stress Scale (PSS) measures the reduction of stress and consists of 10 items corresponding to 10 different domains (anger, perception of control, irritability, self-trust, expectations, efficacy, control of irritation, self-control, uncontrollable anger, excessive difficulties).

The University of California San Diego Shortness Of Breath Questionnaire (UCSD-SOB) and Cough And Sputum Assessment Questionnaire (CASA-Q), respectively assess self-reported shortness of breath and impact of cough while performing a variety of activities of daily living.

Questionnaires were administered at: enrolment (T0), at the beginning and at the end of the intervention (T1 and T2), and then at each quarterly meeting until the end of the follow-up (T3, T4 and T5).

Statistical Analysis


For POMS and PSS tests, average scores and changes in scores were evaluated at the beginning and the end of the study and also between the different intervals of the follow-up. For SOB and CASA-Q, total scores for each patient were calculated and then changes in the scores were evaluated for statistical significance between the beginning and the end of the study.

Lung function and exercise tolerance were also measured for each patient approximately every 3 months. Spirometry and SB-DLCO were performed according to the available international guidelines, as well as the 6MWT (distance covered).The Wilcoxon test was used to calculate the statistical significance of the changes in the average scores of the POMS and PSS questionnaires between the different times of the follow-up.

A non-parametric test for repeated measures was used to assess changes in lung function tests (FVC and SB-DLCO), 6MWD and questionnaire scores for SOB and CASA-Q between T0, T2 and T4. To handle missing answers in items of the SOB and CASA-Q, we chose to calculate the total score relatively to the maximum theoretical score based on the number of answers provided.

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