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

NCT07593521 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-05-18

No results posted yet for this study

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. 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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Anxiety
  • Depression Disorders
  • Stress

Interventions

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.

Sponsors & Collaborators

  • Université Libre de Bruxelles

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-01
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07593521 on ClinicalTrials.gov