Clinical trial NCT04898972: Mindfulness-based Intervention in COPD Dyads
Official title: Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: dyad
caregiver
mindfulness
COPD
patient
intervention
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in perceived stress measured by Perceived Stress Scale (PSS) at 8 weeks and 16 weeks
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change from baseline in anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change from baseline in depression measured by Patient Health Questionnaire (PHQ-9) at 8 weeks and 16 weeks
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
Secondary outcomes:
measure: Change from baseline in subjective quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) at 8 and 16 weeks.
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change from baseline in mindfulness experience measured by Five Facet Mindfulness Questionnaire (FFMQ) at 8 and 16 weeks.
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change in health-related quality of life measured by Short Form 12 Health Survey (SF-12) at 8 and 16 weeks
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change in impact of the COPD on patient's life measured by COPD Assessment Test (CAT) at 8 weeks and 16 weeks
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
measure: Change in patient's dyspnea measured by the Modified Medical Research Council scale (mMRC) at 8 and 16 weeks
timeFrame: at baseline, after 8 weeks, and after 16 weeks from baseline
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio-medico University of Rome
Study officials:
affiliation: Campus Bio-Medico University
name: Maria Matarese
role: PRINCIPAL_INVESTIGATOR
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