Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07593521

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Anxiety Anxiety Disorders Behavior Chronic Disease Depression Disorders Disease Attributes Lung Diseases Lung Diseases, Obstructive Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Stress

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brussels, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindulness Based Stress Reduction program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2026
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.