Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT04769505
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04769505
Study Brief:
Protocol Section:
NCT04769505