Mindfulness-based Intervention in COPD Dyads

NCT04898972 | Unknown DMC

• 1 other identifier: 29.17 OSS ComEt CBM
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

dyad; caregiver; mindfulness; COPD; patient; intervention

Outcome Measures

Primary Outcomes (3)

• 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).

  at baseline, after 8 weeks, and after 16 weeks from baseline

• 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).

  at baseline, after 8 weeks, and after 16 weeks from baseline

• 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).

  at baseline, after 8 weeks, and after 16 weeks from baseline

Secondary Outcomes (5)

• 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 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 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 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

Study Arms (2)

Mindfulness-based stress reduction intervention

EXPERIMENTAL

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

Behavioral: Mindfulness-based stress reduction intervention

information booklet

ACTIVE COMPARATOR

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

Behavioral: Information on stress reduction

Interventions

Mindfulness-based stress reduction intervention BEHAVIORAL

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.

Mindfulness-based stress reduction intervention

Information on stress reduction BEHAVIORAL

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.

information booklet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-medico University of Rome

Rome, 00121, Italy

RECRUITING

Related Publications (12)

• Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

  PMID: 16443717 BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 BACKGROUND

• Chan RR, Giardino N, Larson JL. A pilot study: mindfulness meditation intervention in COPD. Int J Chron Obstruct Pulmon Dis. 2015 Mar 2;10:445-54. doi: 10.2147/COPD.S73864. eCollection 2015.

  PMID: 25767382 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Harrison SL, Lee A, Goldstein RS, Brooks D. Perspectives of healthcare professionals and patients on the application of mindfulness in individuals with chronic obstructive pulmonary disease. Patient Educ Couns. 2017 Feb;100(2):337-342. doi: 10.1016/j.pec.2016.08.018. Epub 2016 Aug 20.

  PMID: 27567496 BACKGROUND

• Harrison SL, Lee A, Janaudis-Ferreira T, Goldstein RS, Brooks D. Mindfulness in people with a respiratory diagnosis: A systematic review. Patient Educ Couns. 2016 Mar;99(3):348-355. doi: 10.1016/j.pec.2015.10.013. Epub 2015 Oct 23.

  PMID: 26561308 BACKGROUND

• Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

  PMID: 20350028 BACKGROUND

• Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.

  PMID: 7042457 BACKGROUND

• Mularski RA, Munjas BA, Lorenz KA, Sun S, Robertson SJ, Schmelzer W, Kim AC, Shekelle PG. Randomized controlled trial of mindfulness-based therapy for dyspnea in chronic obstructive lung disease. J Altern Complement Med. 2009 Oct;15(10):1083-90. doi: 10.1089/acm.2009.0037.

  PMID: 19848546 BACKGROUND

• Pbert L, Madison JM, Druker S, Olendzki N, Magner R, Reed G, Allison J, Carmody J. Effect of mindfulness training on asthma quality of life and lung function: a randomised controlled trial. Thorax. 2012 Sep;67(9):769-76. doi: 10.1136/thoraxjnl-2011-200253. Epub 2012 Apr 27.

  PMID: 22544892 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Matarese

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Matarese

CONTACT

003922541; m.matarese@unicampus.it

Claudio Pedone

CONTACT

00392251; c.pedone@unicampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: April 20, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 3, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, 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

Locations

IT (1)