Mindfulness-based Intervention in COPD Dyads (MIND)

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Mindfulness-based stress reduction intervention; Behavioral: Information on stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT04898972

29.17 OSS ComEt CBM

Details and patient eligibility

About

This study evaluates the effectiveness of a Mindfulness-Based Stress Reduction intervention (MBSRI) on the reduction of stress, anxiety, and depression in people with COPD and their family caregivers. The experimental group will receive the MBSRI and the control group an informational intervention on stress management.

Full description

People affected by Chronic Obstructive Pulmonary Disease (COPD) and their family caregivers (named dyads) often suffer from psychological distress, because of the physical problems and social isolation imposed by the disease. Such psychological distress can influence the ability of patients and caregivers to manage the disease. Mindfulness-based interventions have showed benefits in improving the psychological status in various clinical situations. A 8-week mindfulness based-stress reduction intervention will be offered to a group of COPD patient-caregiver dyads and its effectiveness will be assessed comparing the effects on a control group to whom an informational intervention on stress reduction will be carried out.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persons able to read and understand Italian.
• people affected by COPD stage C (GOLD 3 o 4, and/or 2 or more exacerbations per year or 1 or more hospitalizations for exacerbations and score of COPD assessment test-CAT < 10 or mMRC 0-1).
• People affected by COPD stage D (GOLD 3 o 4, and/or 2 or more exacerbations per year or 1 or more hospitalizations for exacerbations and score of COPD assessment test-CAT ≥ 10 or mMRC ≥ 2).

Exclusion criteria

• Persons or dyads not able to guarantee the presence on the MBSR intervention sessions for the four months requested.
• Persons with diagnosis of anxiety or depression.
• Persons that have practiced before or actually practice yoga or mindfulness.
• Persons with cognitive impairment.
• Persons under continuous oxygen therapy.
• Persons with diagnosis of cancer or other terminal diseases or any psychiatric problem.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Mindfulness-based stress reduction intervention

Experimental group

Description:

Patient-family caregiver dyads will take part in 8-week Mindfulness-based stress reduction intervention (MBSR).

Treatment:

Behavioral: Mindfulness-based stress reduction intervention

information booklet

Active Comparator group

Description:

Patient-informal caregiver dyads will receive an informative booklet on stress reduction strategies

Treatment:

Behavioral: Information on stress reduction