Chronic Obstructive Pulmonary Disease (COPD)NCT02042976
Mindfulness-based Cognitive Therapy for Chronic Obstructive Pulmonary Disease
A study testing Mindfulness-based cognitive therapy and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Obstructive Lung Disease, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease
- What is being tested?
- Mindfulness-based cognitive therapy and Pulmonary rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2014to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe to very severe COPD
- motivated to participate in pulmonary rehabilitation
- sufficient mobility to attend pulmonary rehabilitation
Who cannot join
- certain comorbidities (e.g. unstable coronary complications, psychiatric illness)
- severe cognitive disability (e.g. dementia)
- inability to speak Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease, Chronic Bronchitis, Emphysema
- Being tested
- Mindfulness-based cognitive therapy, Pulmonary rehabilitation
- Keywords
- Chronic obstructive pulmonary disease (COPD), Mindfulness-based cognitive therapy (MBCT), Behavioural intervention, Quality-of-life, Anxiety, Depression, Physical health status
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based cognitive therapyBehavioural
Pulmonary rehabilitationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based cognitive therapy + pulmonary rehabilitation | Experimental | 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. Receives: Behavioral: Mindfulness-based cognitive therapy; Behavioral: Pulmonary rehabilitation |
| Pulmonary rehabilitation only | Active comparator | An 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education. Receives: Behavioral: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in physical health status impairment on the COPD Assessment Test (CAT) six months after termination of the 8-week treatment program
Measured: 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
Measured: Baseline, 6-mo. follow-up
Secondary outcomes (2)
Change from baseline in physical activity at week 8
Measured by accelerometry
Measured: Baseline, Week 8
Change from baseline in inflammation at week 8
Measured by analysis of pro-inflammatory mRNA levels (IL-6, IL-8, IL-17E, TNF-alpha)
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Robert Zachariae, MSc DMSci, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02042976
- Sponsor's protocol ID
- MBCT-KOL-2014
- Status last verified
- Jun 2014
- First submitted
- 17 Jan 2014
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20447795Coventry 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.
PubMed 17535503Rose 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.
PubMed 12135822Farver-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.
PubMed 29386337
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Mindfulness-based Cognitive Therapy (MBCT) for Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02042976
- Acronym / sponsor ID
- MBCT-KOL-2014
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Chronic Obstructive Lung Disease, Chronic Obstructive Airway Disease, Chronic Bronchitis, Emphysema
- Keywords
- Chronic obstructive pulmonary disease (COPD), Mindfulness-based cognitive therapy (MBCT), Behavioural intervention, Quality-of-life, Anxiety, Depression, Physical health status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Feb 2014
- Primary completion
- Sep 2016 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based cognitive therapy + pulmonary rehabilitation | Experimental | Behavioral: Mindfulness-based cognitive therapy, Behavioral: Pulmonary rehabilitationAn 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 comparator | Behavioral: Pulmonary rehabilitationAn 8-week standardised rehabilitation programme consisting of physical exercise and COPD-specific patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe to very severe COPD
- motivated to participate in pulmonary rehabilitation
- sufficient mobility to attend pulmonary rehabilitation
Key exclusion criteria (3 listed)
- certain comorbidities (e.g. unstable coronary complications, psychiatric illness)
- severe cognitive disability (e.g. dementia)
- inability to speak Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based cognitive therapy | Behavioural | Mindfulness-based cognitive therapy + pulmonary rehabilitation |
| Pulmonary rehabilitation | Behavioural | Mindfulness-based cognitive therapy + pulmonary rehabilitation, Pulmonary rehabilitation only |
Primary outcome
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
2 secondary outcomes
Change from baseline in physical activity at week 8
Time frame: Baseline, Week 8
Change from baseline in inflammation at week 8
Time frame: Baseline, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Background: PubMed 20447795Baraniak 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.
- Background: PubMed 17535503Coventry 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.
- Background: PubMed 12135822Rose 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.
- Derived from this study: PubMed 29386337Farver-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zachariae, MSc DMSci study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based cognitive therapy and Pulmonary rehabilitation in people with Chronic Obstructive Pulmonary Disease (COPD) and Chronic Obstructive Lung Disease, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02042976, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.