Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
Change from baseline in anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)
研究者
Maria Matarese
Associate Professor
Campus Bio-Medico University