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

Eleonora Volpato, Paolo Banfi, Francesco Pagnini, Eleonora Volpato, Paolo Banfi, Francesco Pagnini

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov, ID: NCT02499653 . Registered on 14 July 2015.

Keywords: Acceptance; Adherence; Chronic obstructive pulmonary disease (COPD); Clinical psychology; Health economics; Health psychology; Non-invasive ventilation (NIV).

Figures

Fig. 1
Fig. 1
Flowchart of the study design
Fig. 2
Fig. 2
Study procedure: schedule of enrolment, interventions and assessments, reflecting the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure

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