An interventional study of Mindulness Based Stress Reduction program in Chronic Obstructive Pulmonary Disease (COPD), Anxiety and Depression Disorders, sponsored by Université Libre de Bruxelles. Active, not recruiting at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Université Libre de Bruxelles · Not applicable, Interventional, and Supportive care
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 44 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Université Libre de Bruxelles is the lead sponsor of 44 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants received a structured mindfulness-based stress reduction program in addition to standard care
Behavioral: Mindulness Based Stress Reduction program
Participants received standard care only. In Phase 2, women were recruited to complete the control group
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.
Hospital Anxiety and Depression Scale total score
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.
Time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Perceived stress
Change in perceived stress assessed using the Perceived Stress Scale (PSS). Scores range from 0 to 40, with higher scores indicating greater perceived stress.
Time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
State and trait anxiety
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.
Time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Disease-Specific Quality of Life
Change in disease-specific quality of life assessed using the Chronic Respiratory Questionnaire (CRQ).
Time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Medication Adherence
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.
Time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Plan to share: Undecided
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This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Université Libre de Bruxelles