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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Psychological Intervention

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).

Group Type EXPERIMENTAL

Psychological Intervention

Intervention Type BEHAVIORAL

Videos

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

Group Type ACTIVE_COMPARATOR

Videos

Intervention Type BEHAVIORAL

Interventions

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Psychological Intervention

Intervention Type BEHAVIORAL

Videos

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No