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

NCT07593521 | Active Not Recruiting

• 2 other identifiers: SRB2024111Iris Recherche
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

mindfulness based stress reduction; respiratory disease; quality of life; pilot study; COPD; psychological disorders; mental health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, post-intervention (10 weeks), 6 months, and 12 months

Secondary Outcomes (2)

• Perceived stress

  Baseline, post-intervention (10 weeks), 6 months, and 12 months

• State and trait anxiety

  Baseline, post-intervention (10 weeks), 6 months, and 12 months

Other Outcomes (2)

• Disease-Specific Quality of Life

  Baseline, post-intervention (10 weeks), 6 months, and 12 months

• Medication Adherence

  Baseline, post-intervention (10 weeks), 6 months, and 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants received a structured mindfulness-based stress reduction program in addition to standard care

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

Interventions

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Université Libre de Bruxelles: lead

Study Sites (1)

Unknown Facility

Brussels, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Anxiety Disorders; Respiration Disorders; Mental Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Personal Satisfaction; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 5, 2025
• First Posted: May 18, 2026
• Study Start: September 1, 2015
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2025-07

Locations

BE (1)