Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Campus Bio-Medico University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change from baseline in anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.
- Last Updated
- 4 years ago
Overview
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.
Investigators
Maria Matarese
Associate Professor
Campus Bio-Medico University
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.
Outcomes
Primary Outcomes
Change from baseline in anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.
Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline
The anxiety level will be measured in patients and caregivers using the 7-item Generalized Anxiety Disorder scale (GAD-7). Its scores range from 0 to 21. Cut points of 5, 10, and 15 represent mild, moderate, and severe levels of anxiety. Change = (8 weeks- baseline scores) (16 weeks-baseline scores), and (16-weeks-8 weeks scores).
Change from baseline in perceived stress measured by Perceived Stress Scale (PSS) at 8 weeks and 16 weeks
Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline
The perceived stress entails the feelings or thoughts that an individual has about how much stress they are under at a given point in time. It will be measured in patients and caregivers using the Perceived Stress Scale (PSS) that is a 10 item-self-report instrument: its score ranges from 0 to to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Change = (8 weeks- baseline scores) (16 weeks-baseline scores), and (16-weeks-8 weeks scores).
Change from baseline in depression measured by Patient Health Questionnaire (PHQ-9) at 8 weeks and 16 weeks
Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline
The depressive symptoms in patients and caregivers will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Its score range from 0 (no symptoms) to 27 (nearly daily symptoms). Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depression, respectively. Change = (8 weeks- baseline scores) (16 weeks-baseline scores), and (16-weeks-8 weeks scores).
Secondary Outcomes
- Change from baseline in subjective quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) at 8 and 16 weeks.(at baseline, after 8 weeks, and after 16 weeks from baseline)
- Change from baseline in mindfulness experience measured by Five Facet Mindfulness Questionnaire (FFMQ) at 8 and 16 weeks.(at baseline, after 8 weeks, and after 16 weeks from baseline)
- Change in impact of the COPD on patient's life measured by COPD Assessment Test (CAT) at 8 weeks and 16 weeks(at baseline, after 8 weeks, and after 16 weeks from baseline)
- Change in health-related quality of life measured by Short Form 12 Health Survey (SF-12) at 8 and 16 weeks(at baseline, after 8 weeks, and after 16 weeks from baseline)
- Change in patient's dyspnea measured by the Modified Medical Research Council scale (mMRC) at 8 and 16 weeks(at baseline, after 8 weeks, and after 16 weeks from baseline)