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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Hospital Anxiety and Depression Scale total score — 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.

Trial sites (1)

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