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Search / Trial NCT04769505

Mindfulness-based Interventions in COPD Patients

Launched by KARL LANDSTEINER INSTITUTE FOR LUNG RESEARCH AND PNEUMOLOGICAL ONCOLOGY · Feb 23, 2021

Trial Information

Current as of July 21, 2025

Completed

Keywords

ClinConnect Summary

Background:

Patients with chronic obstructive pulmonary disease (COPD) do not only suffer from somatic symptoms but also from symptoms of anxiety and depression (defined as psychological distress) as well as stress. As pharmacological interventions showed only limited effectiveness in targeting the latter, a need for additional treatment options emerges. In other chronic conditions, mindfulness-based interventions (MBIs) are effective in reducing symptoms of psychological distress and stress. Despite first promising results, research on MBIs in COPD patients is still scarce and mixed regar...

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • 1. spirometry confirmed (FEV1\<80%) COPD diagnosis
  • 2. psychological distress (as assessed by the Hospital Anxiety and Depression Scale): HADS-A ≥ 8 OR HADS-D ≥ 8 OR\*
  • 3. age ≥ 40 years
  • 4. ability to understand German
  • 5. physical and mental capability to attend the intervention, judged by the treating physician
  • 6. life expectancy \> 6 months as judged by treating physician
  • 7. ability to use a smartphone
  • 8. ability not to smoke for the duration of the measurement time points (2-3 hours) (This criterion has been added later, because we learned that this was a problem for some participants. However, smoking during the measurements heavily affects biomarker data and the subjective stress response to a stress induction protocol.)
  • Exclusion Criteria:
  • 1. auditory impairment
  • 2. active asthma diagnosis ("Regardless of your COPD, have you had allergies and asthma in childhood or adolescence and needed medication for them at that time?" If no: No active asthma. If yes: "Is your asthma active and a problem now in addition to your COPD and do you currently need asthma medications because of it?" If no: No active asthma. If yes: exclusion)\*\*
  • 3. any other known severe comorbidities such as heart failure (LVF\<35%), uncontrolled diabetes, concomitant cancer, stroke, unstable coronary heart disease, respiratory failure
  • 4. history of/current severe psychological disorder (e.g. schizophrenia, severe cognitive impairment)
  • 5. current acute exacerbation of COPD
  • 6. any other relevant acute health crisis interfering with the study intervention (e.g. Covid-19)
  • 7. receiving any psychosocial treatment (e.g. psychotherapy)
  • 8. regular other systematic mind-body-practice
  • (\*) When the only exclusion criterion was the HADS, which was often the case, we contacted the participants two months later to screen them again and included them, if they were eligible.
  • (\*\*) We further specified this criterion, as we learned that many patients were told to probably have asthma without them knowing exactly if they had an active asthma diagnosis.

About Karl Landsteiner Institute For Lung Research And Pneumological Oncology

The Karl Landsteiner Institute for Lung Research and Pneumological Oncology is a leading research organization dedicated to advancing the understanding and treatment of respiratory diseases and lung cancer. With a focus on innovative clinical trials and translational research, the institute aims to improve patient outcomes through the development of novel therapeutic strategies and diagnostic tools. By fostering collaboration among interdisciplinary teams of researchers, clinicians, and industry partners, the institute is committed to translating scientific discoveries into effective clinical applications, ultimately enhancing the quality of care for patients affected by lung-related conditions.

Locations

Vienna, , Austria

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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