Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2017 Feb 6;18(1):59.
doi: 10.1186/s13063-017-1802-1.

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  1   2 , Paolo Banfi  3 , Francesco Pagnini  4   5
Affiliations
Randomized Controlled Trial

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 et al. Trials. .

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).

PubMed Disclaimer

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
See this image and copyright information in PMC

References

    1. World Health Organization. The world health report 2000: health systems: improving performance. World Health Organization. 2000.
    1. Institute for Health Metrics and Evaluation. The global burden of disease: generating evidence, guiding policy. 2013.
    1. Fabbri LM, Hurd SS. Global strategy for the diagnosis, management and prevention of COPD: 2003 update. Eur Respir J. 2003;22:1. doi: 10.1183/09031936.03.00063703. - DOI - PubMed
    1. Wells KB. Detection of depressive disorder for patients receiving prepaid or fee-for-service care. Results from the Medical Outcomes Study. JAMA. 1989;262:3298–302. doi: 10.1001/jama.1989.03430230083030. - DOI - PubMed
    1. Williams JW, Mulrow CD, Kroenke K, Dhanda R, Badgett RG, Omori D, Lee S. Case-finding for depression in primary care: a randomized trial. Am J Med. 1999;106(1):36–43. - PubMed

Publication types

MeSH terms

Associated data