Chronic Obstructive Pulmonary Disease (COPD)NCT07593521
Pilot Study on Mindfulness Based Stress Reduction (MBSR) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing Mindulness Based Stress Reduction program in people with Chronic Obstructive Pulmonary Disease (COPD) and Anxiety, run by Université Libre de Bruxelles at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Anxiety, Depression Disorders
- What is being tested?
- Mindulness Based Stress Reduction program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2015to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- severe exacerbation of COPD within the previous four weeks prior
- presence of any active oncological disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Mindulness Based Stress Reduction program
- Keywords
- mindfulness based stress reduction, respiratory disease, quality of life, pilot study, COPD, psychological disorders, mental health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Anxiety Disorders, Respiration Disorders, Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindulness Based Stress Reduction programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants received a structured mindfulness-based stress reduction program in addition to standard care Receives: Behavioral: Mindulness Based Stress Reduction program |
| control group | No intervention | Participants received standard care only. In Phase 2, women were recruited to complete the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, post-intervention (10 weeks), 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Sep 2015
- Primary completionJan 2026
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saida Bensliman, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593521
- Sponsor's protocol ID
- SRB2024111
- Other IDs
- Iris Recherche
- Status last verified
- Jul 2025
- First submitted
- 5 Jul 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on Mindfulness Based Stress Reduction (MBSR) in Patients With Chronic Obstructive Pulmonary Disease (COPD): Clinical Outcomes Over 12 Months
- ClinicalTrials.gov ID
- NCT07593521
- Acronym / sponsor ID
- SRB2024111
- Keywords
- mindfulness based stress reduction, respiratory disease, quality of life, pilot study, COPD, psychological disorders, mental health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- Jan 2026 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- 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.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mindulness Based Stress Reduction programParticipants received a structured mindfulness-based stress reduction program in addition to standard care |
| control group | No intervention | –Participants received standard care only. In Phase 2, women were recruited to complete the control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- severe exacerbation of COPD within the previous four weeks prior
- presence of any active oncological disease.
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 |
|---|---|---|
| Mindulness Based Stress Reduction programThe 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. | Behavioural | Intervention group |
Primary outcome
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.
2 secondary outcomes
Perceived stress
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindulness Based Stress Reduction program in people with Chronic Obstructive Pulmonary Disease (COPD) and Anxiety, run by Université Libre de Bruxelles at 1 site in Belgium.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 18 May 2026. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hospital Anxiety and Depression Scale total score (time frame: Baseline, post-intervention (10 weeks), 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.