Mindfulness-based Cognitive Therapy for Chronic Obstructive Pulmonary Disease

February 20, 2017 updated by: University of Aarhus

A Randomised Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) for Patients With Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Aarhus C
      • Aarhus, Aarhus C, Denmark, 8000
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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: Pulmonary rehabilitation
Behavioral: Mindfulness-based cognitive therapy
Active Comparator: Pulmonary rehabilitation only
An 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education.
Behavioral: Pulmonary rehabilitation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
Baseline, 6-mo. follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in physical activity at week 8
Time Frame: Baseline, Week 8
Measured by accelerometry
Baseline, Week 8
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)
Baseline, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Aarhus

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aarhus University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Robert Zachariae, MSc DMSci, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBCT-KOL-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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