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Mindfulness-based Intervention in COPD Dyads (MIND)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Mindfulness-based stress reduction intervention

Information on stress reduction

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring dyad, caregiver, mindfulness, COPD, patient, intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Campus Bio-medico University of RomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-based stress reduction intervention

information booklet

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in perceived stress measured by Perceived Stress Scale (PSS) at 8 weeks and 16 weeks

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 anxiety level measured by Generalized Anxiety Disorder scale (GAD-7) at 8 weeks and 16 weeks.

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 depression measured by Patient Health Questionnaire (PHQ-9) at 8 weeks and 16 weeks

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 Outcome Measures

Change from baseline in subjective quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) at 8 and 16 weeks.

The quality and patterns of sleep in patients and caregivers will be measured by PSQI that is a self-report questionnaire measuring seven areas: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. The global score ranges from 0 to 21, the higher the score, the worse the sleep quality. A global score of 5 or more indicates poor sleep quality; Change = (8 weeks- baseline scores) (16 weeks-baseline scores), and (16-weeks-8 weeks scores).

Change from baseline in mindfulness experience measured by Five Facet Mindfulness Questionnaire (FFMQ) at 8 and 16 weeks.

The mindfulness abilities in patients and caregivers will be measured by a self-reported questionnaire, FFMQ, that comprises 39 items assessing five facets of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Higher global score shows a higher mindfulness disposition. Change = (8 weeks- baseline score), (16 weeks-baseline scores), and (16 weeks-8 weeks scores).

Change in health-related quality of life measured by Short Form 12 Health Survey (SF-12) at 8 and 16 weeks

The physical and mental health-related quality of life of patients and caregivers will by measured by the SF-12 that comprises 12 items. Higher the scores the better the quality of life. Change = (8 weeks- baseline scores), (16 weeks-baseline scores), and (16 weeks-8 weeks scores).

Change in impact of the COPD on patient's life measured by COPD Assessment Test (CAT) at 8 weeks and 16 weeks

The CAT is a 8-item instrument that assesses health-related quality of life and symptom burden in COPD patients. Range of CAT scores from 0-40. Higher scores denote a more severe impact. Change = (8 weeks- baseline scores), (16 weeks-baseline scores), and (16 weeks-8 weeks scores).

Change in patient's dyspnea measured by the Modified Medical Research Council scale (mMRC) at 8 and 16 weeks

The mMRC is a 5-point (0-4) scale that will be used to measure the severity of dyspnea in patients. Higher scores mean worse dyspnea. Change = (8 weeks-baseline scores), (16 weeks-baseline scores), and (16 weeks-8 weeks scores).

Full Information

NCT ID

NCT04898972

First Posted

May 19, 2021

Last Updated

August 2, 2021

Sponsor

Campus Bio-Medico University

1. Study Identification

Unique Protocol Identification Number

NCT04898972

Brief Title

Mindfulness-based Intervention in COPD Dyads

Acronym

MIND

Official Title

Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

dyad, caregiver, mindfulness, COPD, patient, intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness-based stress reduction intervention

Arm Type

Experimental

Arm Description

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

Arm Title

information booklet

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness-based stress reduction intervention

Intervention Description

The 8-group sessions of MBSR will be conducted once a week, lasting two and a half hours, with two additional sessions in the following two months. Between sessions, participants will have to practice at home for 45 minutes a day, 6 days a week. For the practice, patients and caregivers will be provided with audio files containing the meditations proposed in the classroom, readings, and the diary of the practice. During the sessions, the following mindfulness-based techniques will be introduced: body scan; sitting meditation; awareness movement exercises; and walking meditation.The sessions will be held face to face or online using common videoconferencing platforms, such as Skype or Zoom, based on the preferences of the participants. This will facilitate the participation of patients and caregivers, overcoming the obstacles related to travel. The course will be taught by certified mindfulness teachers with experience in MBSR interventions on patients with respiratory diseases.

Intervention Type

Behavioral

Intervention Name(s)

Information on stress reduction

Intervention Description

COPD patient-caregiver dyads will be delivered by hand, sent by email or by post an information booklet "Coping with your chronic disease", targeting COPD patients, to teach them how to manage stress. This booklet, available in Italian, provides simple information on the meaning of stress and anxiety, and suggests some actions that people can implement at home to reduce stress.

Primary Outcome Measure Information:

Title

Change from baseline in perceived stress measured by Perceived Stress Scale (PSS) at 8 weeks and 16 weeks

Description

Time Frame