Abstract
BackgroundPeople with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Rather than being merely a consequence of symptom-related physical impairments these additional problems may be part of the clinical course of the condition. The relationship between the physical and psychological aspects of the condition is illustrated by the patterns of use of non-invasive ventilation (NIV); NIV is often rejected or used inappropriately, resulting in clinical deterioration and an increase in health care costs.The study aims to analyse the effects of psychological support on the acceptance of, and adherence to, NIV. The primary outcome will be a latent variable related to indices of use of NIV equipment and adherence to treatment regime; while survival rates and psychological variables will constitute the secondary outcomes.MethodsA two-arm randomised controlled trial will be conducted. We aim to recruit 150 COPD patients for whom NIV is indicated. The experimental group will receive a brief course of psychological support that will include counselling, relaxation and mindfulness-based exercises. In some cases, it will also include neuropsychological rehabilitation exercises. Support will be delivered via four to eight meetings at the HD Respiratory Rehabilitation Unit, at home or via telemedicine. Controls will receive standard care and watch educational videos related to the management of their disease.DiscussionThis investigation will gain insight about the role of a psychological intervention as part of a treatment plan during the process of adaptation to NIV in COPD patients.Trial registrationClinicalTrials.gov, ID: NCT02499653. Registered on 14 July 2015.
Highlights
People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits
The primary outcome will be a latent variable related to indices of use of non-invasive ventilation (NIV) equipment and adherence to treatment regime: the effects on change from baseline in acceptance to NIV in Chronic obstructive pulmonary disease (COPD) patients at 3, 6 and 12 months as measured by weekly means and standard deviations of hours of use of NIV as recorded by the ventilator and changes in adherence defined as the difference between prescribed and effective NIV hours
As part of the ‘single-patient’ approach patients will be free to choose the setting in which they receive the intervention; this may make it difficult to achieve an even distribution of settings
Summary
People with chronic obstructive pulmonary disease (COPD) sometimes experience anxiety, depression and comorbid cognitive deficits. Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the world [1], the seventh cause of disability-adjusted life years (DALYs) and the tenth cause of early death (measured as years of life lost (YLL)) [2] This clinical condition involves an irreversible obstruction of the airways, associated with progressive and chronic inflammation of the lung tissue; it develops slowly and adversely affects both quality of life (QoL) and psychological wellbeing [3], leading to high levels of anxiety and depression [4, 5]. COPD is associated with a significant risk of developing mild cognitive impairment, especially in patients older than 70 years [18]
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