Chronic Obstructive Pulmonary Disease ExacerbationSPIROMINDNCT04769505
Mindfulness-based Interventions in COPD Patients
A study testing digital mindfulness-based intervention (MBI) in people with Chronic Obstructive Pulmonary Disease Exacerbation, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
Trial 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 as well as stress. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease Exacerbation
- What is being tested?
- digital mindfulness-based intervention (MBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 1 Apr 2021to 27 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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)
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients
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 as well as stress.
Read the 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 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 regarding their effects. Furthermore, it is crucial to implement mental health interventions adapted to the needs of COPD patients. Due to often experienced physical limitations and impaired mobility, digital MBIs seem particularly promising.
Aim and Research Questions:
Building on the above, this pilot randomized controlled trial aims to examine a) the feasibility of a brief digital MBI for COPD patients and b) its effects on psychological distress and stress.
Methods:
30 psychologically distressed (assessed by the Hospital Anxiety and Depression Scale, HADS-A ≥ 8 or HADS-D ≥ 8) COPD patients are screened for inclusion and exclusion criteria in a telephone interview and randomly assigned to the MBI (plus treatment as usual) or waitlist control group (treatment as usual). After a single face-to-face introductory session, patients in the MBI condition are instructed to conduct at least one of four brief audio-guided mindfulness exercises (10-15min) daily for 8 weeks, delivered on their smartphones. Following an ecological momentary approach, psychological and respiratory variables (e.g. subjective stress, dyspnoea) are assessed before and after each exercise. These data will be analysed using multilevel modelling. Moreover, primary (psychological distress) and secondary outcomes (e.g. chronic stress, fatigue) are measured at baseline, 4 weeks, 8 weeks, and follow-up, including questionnaires and assessments of biological stress markers (hair cortisol, heart rate variability, electrodermal activity). The data will be analysed using repeated measures ANOVAs. Finally, in semi-structured telephone exit interviews with 15 patients of the MBI group, the intervention's feasibility will be explored using a thematic analysis approach.
- Being tested
- digital mindfulness-based intervention (MBI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital mindfulness-based intervention (MBI)Behavioural
The digital MBI consists of four auditory guided mindfulness exercises lasting between 10 and 15 minutes. The four exercises are a body scan and three sitting meditations (awareness of the heartbeat, awareness of the body, awareness of sounds). The exercises can be conducted via a software (https://www.movisens.com/de/produkte/movisensxs/) on participants' smartphones. Participants will be familiarized with the concept of mindfulness and the intervention in a single face-to-face introductory session. Additionally, participants will receive a manual, containing all relevant information. Participants will be instructed to practice at least once daily over the course of eight weeks. We recommended to come up with a fixed time point for the mindfulness practice to facilitate a routine. They can choose individually between the exercises. After the intervention period, participants received the exercises as audio files and could continue practicing.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual. Receives: Behavioral: digital mindfulness-based intervention (MBI) |
| Wait list control group | No intervention | Participants receive treatment as usual during the intervention period. They are provided with the digital mindfulness-based intervention (MBI) after the intervention period. The waitlist control group receives the same intervention as the intervention group, with the exception of using not using the exercises via the software on the smartphone, but receiving the exercises as audio files. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement, interpreting both subscales for anxiety and depression
Measured: baseline - 4 weeks
Psychological distress
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement, interpreting both subscales for anxiety and depression
Measured: baseline - 8 weeks
Patient's experiences with the digital MBI
patients' experiences assessed in the exit interview (qualitative and quantitative data)
Measured: 8 weeks
Secondary outcomes (11)
Chronic stress
assessed by Perceived Stress Scale (PSS-10; Cohen \& Williamson, 1988; German version Klein et al., 2016), scores 0-40, lower scores indicate improvement
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Health related quality of life
Chronic Respiratory Questionnaire (CRQ-SAS; German version Schünemann et al., 2003), scores: 20-140, higher scores indicate improvement
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Health status impairment
COPD Assessment Test (CAT; Jones et al., 2009), scores 0-40, lower scores indicate improvement
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Fatigue
Multidimensional Fatigue Inventory (MFI-20; German version Schwarz, Krauss, \& Hinz, 2003), scores 0-80, items have different polarity
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Mindfulness
Freiburger Mindfulness Inventory short form (FMI short form; Walach, Buchheld, Buttenmüller, Kleinknecht, \& Schmidt, 2006), scores 0-42, higher scores indicate improvement
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Self-compassion
Self-Compassion Scale short form (SCS short form; Raes, Pommier, Neff, \& Van Gucht, 2011; German version Hupfeld \& Ruffieux, 2011), scores 12-60, items have different polarity
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Breathlessness catastrophizing
Breathlessness Catastrophizing Scale (BCS; Solomon et al., 2015; German version adapted analogue to Pain Catastrophizing Scale Meyer, Sprott, \& Mannion, 2008), scores 0-52, lower scores indicate improvement
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Stress reactivity
the reactivity to stress assessed via examining heart rate variability (RMSSD) during the exposure to a mental stressor (stroop test)
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Stress reactivity
the reactivity to stress assessed via examining skin conductance level during the exposure to a mental stressor (stroop test)
Measured: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Hair cortisol
concentration of hair cortisol (as biomarker for chronic stress)
Measured: baseline, 8 weeks, 4 months, 6 months
Psychological distress
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement
Measured: baseline, 4 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Apr 2021
- Primary completion5 Dec 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease ExacerbationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vienna, WiGeV Klinik Ottakring, Klinik Floridsdorf, Therme Wien Med (Ambulant Pulmonary Rehabilitation)
- Responsible party
- Principal investigator, Georg-Christian Funk, Karl Landsteiner Institute for Lung Research and Pneumological Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769505
- Sponsor's protocol ID
- SPIROMIND 39
- Acronym
- SPIROMIND
- Status last verified
- Mar 2024
- First submitted
- 11 Feb 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tschenett H, Vafai-Tabrizi F, Zwick RH, Valipour A, Funk GC, Nater UM. Digital mindfulness-based intervention for people with COPD - a multicentre pilot and feasibility RCT. Respir Res. 2025 May 26;26(1):199. doi: 10.1186/s12931-025-03243-4.
PubMed 40420253
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients
- ClinicalTrials.gov ID
- NCT04769505
- Acronym / sponsor ID
- SPIROMIND / SPIROMIND 39
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological OncologyUniversity, hospital or other
- Collaborators
- University of Vienna, WiGeV Klinik Ottakring, Klinik Floridsdorf, Therme Wien Med (Ambulant Pulmonary Rehabilitation)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 5 Dec 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 as well as stress.
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 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 regarding their effects. Furthermore, it is crucial to implement mental health interventions adapted to the needs of COPD patients. Due to often experienced physical limitations and impaired mobility, digital MBIs seem particularly promising.
Aim and Research Questions:
Building on the above, this pilot randomized controlled trial aims to examine a) the feasibility of a brief digital MBI for COPD patients and b) its effects on psychological distress and stress.
Methods:
30 psychologically distressed (assessed by the Hospital Anxiety and Depression Scale, HADS-A ≥ 8 or HADS-D ≥ 8) COPD patients are screened for inclusion and exclusion criteria in a telephone interview and randomly assigned to the MBI (plus treatment as usual) or waitlist control group (treatment as usual). After a single face-to-face introductory session, patients in the MBI condition are instructed to conduct at least one of four brief audio-guided mindfulness exercises (10-15min) daily for 8 weeks, delivered on their smartphones. Following an ecological momentary approach, psychological and respiratory variables (e.g. subjective stress, dyspnoea) are assessed before and after each exercise. These data will be analysed using multilevel modelling. Moreover, primary (psychological distress) and secondary outcomes (e.g. chronic stress, fatigue) are measured at baseline, 4 weeks, 8 weeks, and follow-up, including questionnaires and assessments of biological stress markers (hair cortisol, heart rate variability, electrodermal activity). The data will be analysed using repeated measures ANOVAs. Finally, in semi-structured telephone exit interviews with 15 patients of the MBI group, the intervention's feasibility will be explored using a thematic analysis approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: digital mindfulness-based intervention (MBI)Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual. |
| Wait list control group | No intervention | –Participants receive treatment as usual during the intervention period. They are provided with the digital mindfulness-based intervention (MBI) after the intervention period. The waitlist control group receives the same intervention as the intervention group, with the exception of using not using the exercises via the software on the smartphone, but receiving the exercises as audio files. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital mindfulness-based intervention (MBI)The digital MBI consists of four auditory guided mindfulness exercises lasting between 10 and 15 minutes. The four exercises are a body scan and three sitting meditations (awareness of the heartbeat, awareness of the body, awareness of sounds). The exercises can be conducted via a software (https://www.movisens.com/de/produkte/movisensxs/) on participants' smartphones. Participants will be familiarized with the concept of mindfulness and the intervention in a single face-to-face introductory session. Additionally, participants will receive a manual, containing all relevant information. Participants will be instructed to practice at least once daily over the course of eight weeks. We recommended to come up with a fixed time point for the mindfulness practice to facilitate a routine. They can choose individually between the exercises. After the intervention period, participants received the exercises as audio files and could continue practicing. | Behavioural | Intervention group |
Primary outcome
Psychological distress
Time frame: baseline - 4 weeks
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement, interpreting both subscales for anxiety and depression
Psychological distress
Time frame: baseline - 8 weeks
Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement, interpreting both subscales for anxiety and depression
Patient's experiences with the digital MBI
Time frame: 8 weeks
patients' experiences assessed in the exit interview (qualitative and quantitative data)
11 secondary outcomes
Chronic stress
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Health related quality of life
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Health status impairment
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Fatigue
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Mindfulness
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Self-compassion
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Breathlessness catastrophizing
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Stress reactivity
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Stress reactivity
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Hair cortisol
Time frame: baseline, 8 weeks, 4 months, 6 months
Psychological distress
Time frame: baseline, 4 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 40420253Tschenett H, Vafai-Tabrizi F, Zwick RH, Valipour A, Funk GC, Nater UM. Digital mindfulness-based intervention for people with COPD - a multicentre pilot and feasibility RCT. Respir Res. 2025 May 26;26(1):199. doi: 10.1186/s12931-025-03243-4.
- Individual participant dataSharing planned: No
Related trials for Chronic Obstructive Pulmonary Disease Exacerbation
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
RecruitingObservational study
Characteristics and Outcomes of Patients Admitted to ICU for a Severe Acute Exacerbation of COPD.
COPD Exacerbation, ICU
Recruiting
A Prospective Study of Cardiovascular Risk of Patients Admitted for Acute Exacerbation of COPD
COPD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital mindfulness-based intervention (MBI) in people with Chronic Obstructive Pulmonary Disease Exacerbation, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress (time frame: baseline - 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04769505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.