A Psychological Intervention to Promote Acceptance and Adherence to NIV in People With COPD

Don Carlo Gnocchi Onlus Foundation

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Behavioral: Psychological Intervention; Behavioral: Videos

Study type: Interventional

Funder types: Other

Identifiers

NCT02499653

FDG_PSYNIV_COPD01

Details and patient eligibility

About

This study aims to analyze the impact of a brief psychological support intervention in the promotion of the adherence to Non Invasive Ventilation (NIV) among people with Chronic Obstructive Pulmonary Disease (COPD). The investigators expect to see a positive impact of this intervention on both physical and psychological well-being, and consequently, a reduction of health costs.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age> or =18 years
• the voluntary participation to the Study
• inpatients or outpatients
• subjects with Chronic Obstructive Pulmonary Disease (COPD), from moderate (GOLD 2- 50% ≤ FEV1 <80% pred.) to severe (GOLD 3- 30% ≤ FEV1 <50%pred.) (FEV1= Forced Expiratory Volume in the 1st Second)

Exclusion criteria

• refusal of the Informant Consent
• pregnancy
• subjects affected by oncological or psychiatric illnesses
• immune depressive condition as the principal condition
• usage of antidepressant drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Psychological Intervention

Experimental group

Description:

In addition to the standard care, subjects are participating in a brief psychological support, which will include elements of psychological well-being's promotion and cognitive restructuring exercises (mindfulness).

Treatment:

Behavioral: Psychological Intervention

Videos

Active Comparator group

Description:

The subjects assigned in the Control Group watch some videos relating to the management of their disease.

Treatment:

Behavioral: Videos