A psychological intervention to promote acceptance and adherence to non-invasive ventilation in people with chronic obstructive pulmonary disease: study protocol of a randomised controlled trial.
People 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.



A 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.



This 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.



ClinicalTrials.gov, ID: NCT02499653 . Registered on 14 July 2015.
Department of Psychology, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 1, 20123, Milan, Italy. eleonora.volpato@unicatt.it.|HD Respiratory Rehabilitation Unit, IRCCS Fondazione Don Carlo Gnocchi, Via Capecelatro 66, 20148, Milan, Italy. eleonora.volpato@unicatt.it.
Eleonora
0000-0003-0266-6386
E
Volpato
HD Respiratory Rehabilitation Unit, IRCCS Fondazione Don Carlo Gnocchi, Via Capecelatro 66, 20148, Milan, Italy.
Paolo
P
Banfi
Department of Psychology, Università Cattolica del Sacro Cuore, Largo A. Gemelli, 1, 20123, Milan, Italy.|Department of Psychology, Harvard University, Cambridge, MA, USA.
Francesco
F
Pagnini
D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003376:Counseling; D005541:Forced Expiratory Volume; D017048:Health Care Costs; D006801:Humans; D007558:Italy; D008168:Lung / Q000503:physiopathology*; D064866:Mindfulness; D063087:Noninvasive Ventilation / Q000009:adverse effects / Q000191:economics / Q000523:psychology; D010349:Patient Compliance; D010353:Patient Education as Topic; D029424:Pulmonary Disease, Chronic Obstructive / Q000191:economics / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D012064:Relaxation Therapy; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
Acceptance; Adherence; Chronic obstructive pulmonary disease (COPD); Clinical psychology; Health economics; Health psychology; Non-invasive ventilation (NIV)