Pilot Study on Mindfulness Based Stress Reduction (MBSR) in Patients With Chronic Obstructive Pulmonary Disease (COPD)

May 11, 2026 updated by: Saida Bensliman, Université Libre de Bruxelles

Pilot Study on Mindfulness Based Stress Reduction (MBSR) in Patients With Chronic Obstructive Pulmonary Disease (COPD): Clinical Outcomes Over 12 Months

This two-phase exploratory pilot study investigates the impact of a Mindfulness-Based Stress Reduction (MBSR) program on patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation. Phase 1, conducted from 2015 to 2018, explored the potential clinical effects of the intervention. It included a mixed-gender intervention group and a control group composed exclusively of male participants.

In the context of a doctoral research project, Phase 2 was initiated in 2024 to expand the control group by including female participants, thereby improving gender balance and ensuring more robust comparative clinical analysis. All participants were enrolled in a multidisciplinary outpatient pulmonary rehabilitation program at the time of inclusion.

The aim of the study is to evaluate the potential effects of MBSR on psychological symptoms, disease-specific quality of life, perceived stress, and medication adherence in patients with COPD.

The intervention consists of a standardized 8-week MBSR program developed by Jon Kabat-Zinn, including weekly 2.5-hour group sessions, one day-long silent retreat, and daily home practice (approximately 45 minutes per day). Participants are followed for 12 months.

Clinical outcomes are assessed at baseline, post-intervention (10 weeks), 6 months, and 12 months and include:

Anxiety and depression (Hospital Anxiety and Depression Scale - HADS)

Disease-specific quality of life (Chronic Respiratory Questionnaire - CRQ)

Perceived stress (Perceived Stress Scale - PSS)

State and trait anxiety (State-Trait Anxiety Inventory - STAI, Spielberger)

Medication adherence (Morisky Medication Adherence Scale - MMAS)

This study contributes to the growing body of research supporting mindfulness-based interventions as complementary care within pulmonary rehabilitation for chronic respiratory diseases.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This pilot study was designed to extend supportive care for people with COPD by evaluating a non-pharmacological mindfulness-based intervention in the context of pulmonary rehabilitation. COPD is often accompanied by psychological distress and poor adherence to treatment, which can negatively impact patient outcomes. Mindfulness-Based Stress Reduction (MBSR) has shown promise in chronic disease populations, but evidence in COPD remains limited.

The study follows a two-phase exploratory design. In phase 1, the potential clinical effects of integrating MBSR into a hospital-based rehabilitation programme were explored. Although promising, the control group consisted only of men, which limited the validity of clinical comparisons with the mixed intervention group.

To remedy this limitation, phase 2 was launched as part of a doctoral research project. The aim is to strengthen methodological robustness by balancing the control group with female participants. All the participants are involved in a structured outpatient pulmonary rehabilitation programme, which provides a stable framework for evaluating the effects of MBSR.

The study is examining changes in psychological outcomes, quality of life and behavioural measures such as medication adherence. The results will help guide future controlled trials evaluating mindfulness-based interventions in respiratory care.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • 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

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • a confirmed diagnosis of COPD with airflow obstruction, based on Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria , regardless of age, - participation in a pulmonary rehabilitation program either at hospital or at home with a physiotherapist, in accordance with GOLD recommendations
  • ability to read and write in French
  • availability of easy transportation to attend weekly classes.

Exclusion Criteria:

  • severe exacerbation of COPD within the previous four weeks prior
  • presence of any active oncological disease.

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants received a structured mindfulness-based stress reduction program in addition to standard care
Behavioral: Mindulness Based Stress Reduction program
The MBSR intervention follows the standard 8-week curriculum originally developed by Jon Kabat-Zinn, with weekly group sessions, a full-day retreat, and home practice.
No Intervention: control group
Participants received standard care only. In Phase 2, women were recruited to complete the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Anxiety and Depression Scale total score
Time Frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Change in psychological distress from baseline to 12 months, assessed using the total score of the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 42, with higher scores indicating greater psychological distress.
Baseline, post-intervention (10 weeks), 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived stress
Time Frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Change in perceived stress assessed using the Perceived Stress Scale (PSS). Scores range from 0 to 40, with higher scores indicating greater perceived stress.
Baseline, post-intervention (10 weeks), 6 months, and 12 months
State and trait anxiety
Time Frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Change in state and trait anxiety assessed using the State-Trait Anxiety Inventory (STAI-Y). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Baseline, post-intervention (10 weeks), 6 months, and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Specific Quality of Life
Time Frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Change in disease-specific quality of life assessed using the Chronic Respiratory Questionnaire (CRQ).
Baseline, post-intervention (10 weeks), 6 months, and 12 months
Medication Adherence
Time Frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Change in medication adherence assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8). Scores range from 0 to 8, with higher scores indicating better medication adherence.
Baseline, post-intervention (10 weeks), 6 months, and 12 months

Collaborators and Investigators

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

Sponsor

Université Libre de Bruxelles

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 (Actual)

September 1, 2015

Primary Completion (Actual)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

July 5, 2025

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRB2024111
  • Iris Recherche (Other Grant/Funding Number: Fondation Roi Baudouin)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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