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Mindfulness-based Cognitive Therapy for Chronic Obstructive Pulmonary Disease

This study has been completed.
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT02042976
First received: January 17, 2014
Last updated: February 20, 2017
Last verified: June 2014
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Chronic Obstructive Lung Disease Chronic Obstructive Airway Disease Chronic Bronchitis Emphysema Behavioral: Mindfulness-based cognitive therapy Behavioral: Pulmonary rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Supportive Care
Official Title: A Randomised Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change from baseline in physical health status impairment on the COPD Assessment Test (CAT) six months after termination of the 8-week treatment program [ Time Frame: 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 [ Time Frame: Baseline, 6-mo. follow-up ]

Secondary Outcome Measures:
  • Change from baseline in physical activity at week 8 [ Time Frame: Baseline, Week 8 ]
    Measured by accelerometry

  • Change from baseline in inflammation at week 8 [ Time Frame: Baseline, Week 8 ]
    Measured by analysis of pro-inflammatory mRNA levels (IL-6, IL-8, IL-17E, TNF-alpha)


Enrollment: 84
Study Start Date: February 2014
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness-based cognitive therapy + pulmonary rehabilitation
An 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.
Behavioral: Mindfulness-based cognitive therapy Behavioral: Pulmonary rehabilitation
Active Comparator: Pulmonary rehabilitation only
An 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education.
Behavioral: Pulmonary rehabilitation

Detailed Description:

Chronic obstructive pulmonary disease (COPD) is a major burden for the affected patients, who are continuously struggling with the hallmark symptoms breathlessness, cough, and sputum together with high levels of anxiety and depression and impairment of quality of life (QoL). The potential value of complementary interventions in COPD has long been recognised, yet so far, no overall significant effects of psychosocial intervention programs such as cognitive behavioural therapy or supportive/analytical psychotherapy have been found.

Mindfulness-based interventions have been shown to improve levels of physical symptoms, stress, anxiety, depression, and QoL in other chronic conditions, and could also be relevant in COPD. The present randomized controlled trial will test the efficacy of mindfulness-based cognitive therapy (MBCT) in COPD patients. 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.

Patients recruited from the Department of Respiratory Medicine, Aarhus University Hospital, will be randomized to participate in either an 8-week MBCT program as an add-on to the already established pulmonary rehabilitation program (intervention group) or pulmonary rehabilitation only (treatment-as-usual). Questionnaires assessing outcomes, mediators and moderators will be completed before, during, and after the intervention as well as at a 3 and 6 mo. follow-up.

This study will be one of the first to test the efficacy of MBCT in COPD, bringing attention to a patient group that is relatively ignored by the public as well as in the health psychological empirical literature.

After data collection, but prior to analysis, inaccuracies in the content of the registration were discovered. Some changes made prior to recruitment of the first participant had not been registered. The inaccuracies were amended in an update, 15 February 2017: 1) The primary outcome measure of iBODE (objective physical health status) was omitted (no data were collected). 2) The time frame for primary outcomes was changed from "Baseline, week 8" to "Baseline, 6 mo. follow-up". 3) Prior to data collection, three variables to be included in moderator and mediator analyses were added (therapeutic working alliance, mindfulness, and breathlessness catastrophizing).

  Eligibility

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

Inclusion Criteria:

  • severe to very severe COPD
  • motivated to participate in pulmonary rehabilitation
  • sufficient mobility to attend pulmonary rehabilitation

Exclusion Criteria:

  • certain comorbidities (e.g. unstable coronary complications, psychiatric illness)
  • severe cognitive disability (e.g. dementia)
  • inability to speak Danish
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02042976

Locations
Denmark
Aarhus University Hospital
Aarhus, Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Study Director: Robert Zachariae, MSc DMSci Aarhus University Hospital
  More Information

Publications:
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02042976     History of Changes
Other Study ID Numbers: MBCT-KOL-2014
Study First Received: January 17, 2014
Last Updated: February 20, 2017

Keywords provided by University of Aarhus:
Chronic obstructive pulmonary disease (COPD)
Mindfulness-based cognitive therapy (MBCT)
Behavioural intervention
Quality-of-life
Anxiety
Depression
Physical health status

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Pathologic Processes
Bronchial Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 26, 2017