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

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-1802-1) contains supplementary material, which is available to authorized users.

How people with chronic obstructive pulmonary disease perceive their illness: a qualitative study between mind and body

“…The topics that have emerged are therefore relevant from a clinical standpoint. For example, patients for whom the mind/body relationship is particularly relevant, counseling can directly impact the level of adherence [35]. Furthermore, the opportunity of sharing their expertise, or to discuss future perspectives further support the importance of proper psychological support, in particular in group settings.…”

Efficacy and safety of Chou-Ling-Dan granules in the treatment of seasonal influenza via combining Western and traditional Chinese medicine: protocol for a multicentre, randomised controlled clinical trial

“…Forms, lists, logbooks, appointment books and any other listings that link participant ID numbers to other identifying information will be stored in a separate, locked file in an area with limited access. Participants’ study information will not be released outside of the study without the written permission of the participant 34…”

Promoting Acceptance and Adherence to Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

“…The study was a randomized controlled trial, composed of two arms (experimental and control groups, both involving 4–8 weekly sessions) and four assessments (2 × 4 design) at baseline and at 3, 6, and 12 months after recruitment. The study was registered in the ClinicalTrials.gov repository (ID NCT02499653), and the details of the protocol were previously published ( 44 ).…”