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Mindfulness-based Intervention in COPD Dyads (MIND)

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ClinicalTrials.gov Identifier: NCT04898972
Recruitment Status : Recruiting
First Posted : May 24, 2021
Last Update Posted : August 3, 2021
Sponsor:
Information provided by (Responsible Party):
Maria Matarese, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Behavioral: Mindfulness-based stress reduction intervention Behavioral: Information on stress reduction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mindfulness-based Stress Reduction Intervention in Patients With COPD and Their Caregivers
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

Arm Intervention/treatment
Experimental: Mindfulness-based stress reduction intervention
Patient-family caregiver dyads will take part in 8-week Mindfulness-based stress reduction intervention (MBSR).
Behavioral: Mindfulness-based stress reduction intervention
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.

Active Comparator: information booklet
Patient-informal caregiver dyads will receive an informative booklet on stress reduction strategies
Behavioral: Information on stress reduction
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 Measures :
  1. 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).

  2. 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).

  3. 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 Outcome Measures :
  1. Change from baseline in subjective quality of sleep measured by the Pittsburgh Sleep Quality Index (PSQI) at 8 and 16 weeks. [ Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline ]
    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).

  2. Change from baseline in mindfulness experience measured by Five Facet Mindfulness Questionnaire (FFMQ) at 8 and 16 weeks. [ Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline ]
    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).

  3. Change in health-related quality of life measured by Short Form 12 Health Survey (SF-12) at 8 and 16 weeks [ Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline ]
    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).

  4. Change in impact of the COPD on patient's life measured by COPD Assessment Test (CAT) at 8 weeks and 16 weeks [ Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline ]
    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).

  5. Change in patient's dyspnea measured by the Modified Medical Research Council scale (mMRC) at 8 and 16 weeks [ Time Frame: at baseline, after 8 weeks, and after 16 weeks from baseline ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04898972


Contacts
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Contact: Maria Matarese 003922541 ext 1026 m.matarese@unicampus.it
Contact: Claudio Pedone 00392251 ext 1336 c.pedone@unicampus.it

Locations
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Italy
Campus Bio-medico University of Rome Recruiting
Rome, Italy, 00121
Contact: Maria Matarese    003906225411026    m.matarese@unicampus.it   
Sponsors and Collaborators
Campus Bio-Medico University
Investigators
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Principal Investigator: Maria Matarese Campus Bio-Medico University
Publications:
Clari, M., Conti, A., Fontanella, R., Rossi, A., & Matarese, M. (2020). Mindfulness-based programs for people with chronic obstructive pulmonary disease: a mixed methods systematic review. Mindfulness, 1-20.

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Responsible Party: Maria Matarese, Associate Professor, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04898972    
Other Study ID Numbers: 29.17 OSS ComEt CBM
First Posted: May 24, 2021    Key Record Dates
Last Update Posted: August 3, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that will be used in the result publications.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: From the date of study publication up to 4 years later
Access Criteria: Formal request by email from researchers affiliated to university centers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Matarese, Campus Bio-Medico University:
dyad
caregiver
mindfulness
COPD
patient
intervention
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases