Status:
COMPLETED
Mindfulness-based Interventions in COPD Patients
Lead Sponsor:
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Collaborating Sponsors:
University of Vienna
Klinik Ottakring
Conditions:
Chronic Obstructive Pulmonary Disease Exacerbation
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The purpose of this pilot study is to assess the feasibility of a brief digital mindfulness-based intervention for COPD patients and its effectiveness regarding the reduction of psychological distress...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- spirometry confirmed (FEV1\<80%) COPD diagnosis
- psychological distress (as assessed by the Hospital Anxiety and Depression Scale): HADS-A ≥ 8 OR HADS-D ≥ 8 OR\*
- age ≥ 40 years
- ability to understand German
- physical and mental capability to attend the intervention, judged by the treating physician
- life expectancy \> 6 months as judged by treating physician
- ability to use a smartphone
- 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:
- auditory impairment
- 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)\*\*
- any other known severe comorbidities such as heart failure (LVF\<35%), uncontrolled diabetes, concomitant cancer, stroke, unstable coronary heart disease, respiratory failure
- history of/current severe psychological disorder (e.g. schizophrenia, severe cognitive impairment)
- current acute exacerbation of COPD
- any other relevant acute health crisis interfering with the study intervention (e.g. Covid-19)
- receiving any psychosocial treatment (e.g. psychotherapy)
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04769505
Start Date
April 1 2021
End Date
March 27 2023
Last Update
March 18 2024
Active Locations (1)
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1
Klinik Ottakring
Vienna, Austria, 1160