Mindfulness-based Cognitive Therapy for Chronic Obstructive Pulmonary Disease
A Randomised Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) for Patients With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
84
1 country
1
Brief Summary
The purpose of the study is to determine the efficacy of mindfulness-based cognitive therapy (MBCT) as an add-on to pulmonary rehabilitation (treatment as usual, TAU) in chronic obstructive pulmonary disease (COPD). The investigators hypothesize that compared to treatment-as-usual, the add-on of MBCT will result in improved psychological (anxiety, depression) and physical outcomes (physical health status, activity level, inflammatory markers). Furthermore, the investigators will explore the possible moderating role of individual differences in sociodemographic and disease-related characteristics and the perceived quality of the therapeutic alliance, as well as the mediating role of mindfulness, breathlessness catastrophizing, self-efficacy, and self-compassion for the hypothesised effect.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2014
CompletedFirst Posted
Study publicly available on registry
January 23, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedFebruary 23, 2017
June 1, 2014
2.6 years
January 17, 2014
February 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline in physical health status impairment on the COPD Assessment Test (CAT) six months after termination of the 8-week treatment program
Baseline, 6-mo. follow-up
Change from baseline in anxiety and depression on the Hospital Anxiety and Depression Scale (HADS) six months after termination of the 8-week treatment program
Baseline, 6-mo. follow-up
Secondary Outcomes (2)
Change from baseline in physical activity at week 8
Baseline, Week 8
Change from baseline in inflammation at week 8
Baseline, Week 8
Study Arms (2)
Mindfulness-based cognitive therapy + pulmonary rehabilitation
EXPERIMENTALAn 8-week manual-based programme developed by Segal, Williams and Teasdale (2013) adjusted to the COPD population. The programme is delivered as an add-on to an 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education.
Pulmonary rehabilitation only
ACTIVE COMPARATORAn 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education.
Interventions
Eligibility Criteria
You may qualify if:
- severe to very severe COPD
- motivated to participate in pulmonary rehabilitation
- sufficient mobility to attend pulmonary rehabilitation
You may not qualify if:
- certain comorbidities (e.g. unstable coronary complications, psychiatric illness)
- severe cognitive disability (e.g. dementia)
- inability to speak Danish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Aarhus University Hospitalcollaborator
Study Sites (1)
Aarhus University Hospital
Aarhus, Aarhus C, 8000, Denmark
Related Publications (4)
Baraniak A, Sheffield D. The efficacy of psychologically based interventions to improve anxiety, depression and quality of life in COPD: a systematic review and meta-analysis. Patient Educ Couns. 2011 Apr;83(1):29-36. doi: 10.1016/j.pec.2010.04.010. Epub 2010 May 5.
PMID: 20447795BACKGROUNDCoventry PA, Gellatly JL. Improving outcomes for COPD patients with mild-to-moderate anxiety and depression: a systematic review of cognitive behavioural therapy. Br J Health Psychol. 2008 Sep;13(Pt 3):381-400. doi: 10.1348/135910707X203723. Epub 2007 Apr 18.
PMID: 17535503BACKGROUNDRose C, Wallace L, Dickson R, Ayres J, Lehman R, Searle Y, Burge PS. The most effective psychologically-based treatments to reduce anxiety and panic in patients with chronic obstructive pulmonary disease (COPD): a systematic review. Patient Educ Couns. 2002 Aug;47(4):311-8. doi: 10.1016/s0738-3991(02)00004-6.
PMID: 12135822BACKGROUNDFarver-Vestergaard I, O'Toole MS, O'Connor M, Lokke A, Bendstrup E, Basdeo SA, Cox DJ, Dunne PJ, Ruggeri K, Early F, Zachariae R. Mindfulness-based cognitive therapy in COPD: a cluster randomised controlled trial. Eur Respir J. 2018 Jan 31;51(2):1702082. doi: 10.1183/13993003.02082-2017. Print 2018 Feb.
PMID: 29386337DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert Zachariae, MSc DMSci
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2014
First Posted
January 23, 2014
Study Start
February 1, 2014
Primary Completion
September 1, 2016
Last Updated
February 23, 2017
Record last verified: 2014-06