A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology

 
 
 
 
 
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Clinical Study Protocol 
 
 
 
 
 
Version 2.0 / 026.04.21 
 
 
 
 
 
 
 
 
 
 
The information contained in this document is the property of the sponsor of this study. It is therefore 
provided to you in confidence. It is understood that this information will not be disclosed to others 
without written authorization. 

 
 
 
 
 
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EXECUTIVE SUMMARY 
 
 COPD patients frequently experience psychological distress (symptoms of 
anxiety and depression) as well as psychophysiological symptoms of stress. So far, 
pharmacological treatments showed only limited effectiveness. Therefore, a need for further 
treatment options emerges, which was also reported by COPD patients themselves. MBIs were 
shown to be effective in older and chronically ill populations and appear attractive to stable 
COPD patients. Hence, the presented study will follow this idea and investigate an app-based 
mindfulness 
intervention 
using 
ecological 
momentary 
assessment 
(EMA) 
and 
psychophysiological measures. This study’s primary research objective is to examine a) 
whether a brief digital mindfulness-based intervention is feasible for stable COPD patients, 
and b) whether a brief digital mindfulness-based intervention can reduce psychological 
distress in stable COPD patients. Additionally, this study aims to investigate immediate effects 
of mindfulness exercises as well as intermediate and long-term effects on other respiratory, 
psychophysiological and psychological variables. 
 This pilot randomized controlled trial intends to include 30 stable COPD patients, 
who are psychologically distressed and will be randomly assigned to the intervention (app-
based mindfulness + treatment as usual) and waitlist control (treatment as usual) condition. 
The intervention group will be introduced to the intervention in a face-to-face learning phase 
(single day) conducted by the study coordinator while being hospitalized. Patients in the 
intervention group will be instructed to practice mindfulness daily using at least one of 4 short 
exercises (10-15 minutes) over a period of 8 weeks, starting in the hospital and continuing at 
home. The exercises will be delivered by a software (movisensXS). Additionally, dyspnoea, 
stress, relaxation, affect and oxygen saturation (assessed by a pulse oximeter) will be assessed 
before and after each exercise via the software. 
Questionnaire data will be collected equally in both groups at 5 measurements: baseline, after 
4 weeks, after the intervention (8 weeks) and at follow-up (4 and 6 months). Physiological 
measures (heart rate variability, electrodermal activity, heart rate) will be conducted at the 
same 5 measurements, using an ecg and eda sensor (movisens EcgMove4, movisens 
EdaMove4). Physiological measures will be assessed during the conduction of a cognitive 
stress test (Stroop-test), as well as before and after the conduction (at rest). Hair cortisol will 
be collected at baseline, after the intervention (8 weeks) and at follow-up (4 and 6 months). 
Face-to-face exit interviews will be conducted in the intervention group after 8 weeks to further 
assess patients’ experiences with the intervention.  
The primary outcome measures are psychological distress and the intervention’s feasibility. 
The secondary outcome parameters for immediate effects of mindfulness exercises will be 
dyspnoea, stress, relaxation, affect (anxiety, depression, happiness) and oxygen saturation. 
The secondary outcome parameters for intermediate and long-term effects are heart rate 
variability, electrodermal activity, heart rate, health-related quality of life, health status 
impairment, fatigue, breathlessness catastrophizing, perceived and chronic stress, 
mindfulness and self-compassion. Additionally, compliance regarding medication-intake, 
perception of exacerbations, frequency and intensity of exacerbations and hospitalization rate 
as well as patients’ experiences with the intervention are assessed. 

 
 
 
 
 
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 This study will realize a mixed methods analysis. Differences between conditions as 
well as moderating and mediating effects will be calculated. The intermediate pre-post effects 
of mindfulness exercises will be analysed using multi-level analyses (HLM). Interview data will 
be analysed using thematic analysis.  
 The study aims to assess the feasibility of a brief app-based mindfulness 
intervention for stable COPD patients who are psychologically distressed and intends to 
investigate its effects on psychological distress and various other psychological, 
psychophysiological and respiratory variables. The results of this study could serve as basis 
for following large-scale RCTs and advance the future implementation of app-based MBIs as 
add-on treatment in the clinical practice.  
 The study will be conducted in accordance with the Declaration of Helsinki. It will be 
asked for examination and agreement by the ethics committee of the city of Vienna. Ethics 
approval for a similar study for COPD patients following acute exacerbations has already been 
obtained by the ethics committee of the city of Vienna (serial number EK 20-177-VK). 
 
 

 
 
 
 
 
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SPONSOR, INVESTIGATOR, MONITOR AND SIGNATURES 
Karl-Landsteiner-Institut für Lungenforschung und Pneumologische Onkologie 
 
 
Signature (OEL) 
Date 
 
 
) 
 
 
Prim. Priv.-Doz. Dr. Georg-Christian Funk, Klinik Ottakring, Vienna, Austria (principal investigator) 
 
 
Signature 
Date 
 
 
Univ.-Prof. Dr. Urs Markus Nater, Department of Clinical and Health Psychology, University of Vienna, 
Austria  
 
 
Signature 
Date 
 
 
Dr. Florian Vafai-Tabrizi, Klinik Ottakring, Vienna, Austria 
 
 
Signature 
Date 
 
 
Hannah Tschenett, B.Sc., Department of Clinical and Health Psychology, University of Vienna, Austria 
(study coordinator) 
 
 
Signature 
Date 
 
 

 
 
 
 
 
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Medizinische Universität Wien 
KKS - Koordinationszentrum für Klinische Studien 
Währinger Straße 25a, OG 1 
1090 Wien 
 
 
Signature 
Date 
 
2.Medizinische Abteilung mit Pneumologie, Klinik Ottakring, Vienna, Austria 
Abteilung für Innere Medizin und Pneumologie, Klinik Floridsdorf, Vienna, Austria 
 
 
 
: 
Department of Clinical and Health Psychology, University of Vienna, Austria 
 
 
 

 
 
 
 
 
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CLINICAL STUDY PROTOCOL 
 
TITLE 
A pilot randomized controlled trial to examine the feasibility and effects of a brief 
digital mindfulness-based intervention for stable COPD patients 
BACKGROUND 
Multiple reviews showed that symptoms of anxiety and depression (=psychological 
distress) are significantly more prevalent in COPD patients than in the general 
population (Matte et al., 2016; Willgoss & Yohannes, 2013). Both correlate with a 
decrease in health-related quality of life (e.g. Blakemore et al., 2014), but are also 
associated with other worsened health outcomes, such as a poorer functional status, 
higher mortality rates and more frequent and longer hospitalisations (e.g. Atlantis, 
Fahey, Cochrane, & Smith, 2013; Panagioti, Scott, Blakemore, & Coventry, 2014; 
Pumar et al., 2014). Moreover, breathing problems have been identified as major 
stressor for COPD patients (Andenæs, Kalfoss, and Wahl, 2006). If stressful events 
like dyspnoea are experienced frequently, this might determine a maladaptive 
activation of the bodily stress systems, meaning the autonomous nervous system 
(ANS) and the hypothalamic-pituitary-adrenal axis (HPA axis), leading to an ongoing 
dysregulation of these systems and resulting in chronic stress (e.g. Chrousos, 
2009). Studies have shown a general sympathetic overactivity of the ANS in COPD 
patients (Van Gestel, Kohler, & Clarenbach, 2012). Furthermore, COPD is 
characterized by a systemic inflammatory response manifesting with increased 
inflammatory cytokines (Singh et al., 2018). As the inflammatory response is 
regulated by both the ANS as well as the HPA axis (Glaser & Kiecolt-Glaser, 2005), 
this adds up to the evidence of an ongoing dysregulation of these stress systems in 
COPD. Such dysregulations, in turn, are known to increase the risk for mental and 
physical health problems (e.g. Adam et al., 2017). Therefore, it seems crucial to 
address both, psychological distress and stress, in mental health interventions for 
COPD patients. 
In addition, high-quality evidence regarding the effectiveness of pharmacological 
interventions in reducing symptoms of anxiety and depression in COPD is limited 
(Cafarella, Effing, Barton, Ahmed, & Frith, 2013), with psychological interventions 
showing greater treatment efficacy when compared to pharmacotherapy (Usmani, 
Chahhoud, Esterman, & Smith, 2018). Hence, further psychosocial treatment 
approaches focusing on the reduction of psychological distress as well as 
psychophysiological stress responses and dyspnea should be investigated. The 
results of a recent study conducted by our team underline this necessity, as 
hospitalized COPD patients reported the need for further treatment options.  
In our previous study, we were able to show that most hospitalized COPD 
patients (14/20) would be interested in participating in a mindfulness-based 
intervention (MBI). Mindfulness is a promising option in the treatment of COPD 
patients, as it significantly reduced symptoms of stress (psychological and 
physiological parameters), anxiety and depression in previous studies (Cillessen, 
Johannsen, Speckens, & Zachariae, 2019; Pascoe, Thompson, Jenkins, & Ski, 2017). 
Furthermore, mindfulness was beneficial for older adults (Hazlett-Stevens, Singer, & 
Chong, 2019) and patients with other chronic conditions (Bohlmeijer, Prenger, Taal, 
& Cuijpers, 2010). 
Despite the above, the existing evidence on MBIs for COPD patients is very 
scarce. So far, only eight primary studies examined the effects of MBIs on COPD 
patients (e.g. Chan, Giardino, & Llarson, 2015). Two of them investigated brief MBIs 

 
 
 
 
 
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in COPD inpatients (Perkins-Porras et al., 2018; Tan et al., 2019). To summarize the 
few results, MBIs appeared to be feasible and attractive to COPD patients and 
showed a trend for being effective in the improvement of anxiety and depression 
symptoms (Farver-Vestergaard, O’Toole, et al., 2018) and dyspnea (Tan et al., 
2019). Perceived or psychophysiological stress responses have been considered in 
only two studies, which found no effects on perceived stress and inflammatory 
stress markers (Farver-Vestergaard, O’Toole, et al., 2018; Mularski et al., 2009). 
Only one study investigated a digital MBI (Farver-Vestergaard, O’Connor, et al., 
2018), which had very high attendance rates but found only trends in improvement 
of psychological distress. However, digital interventions seem to be especially 
promising for COPD patients, as they are often limited in their mobility and 
therefore seek for interventions feasible for the conduction at home. Moreover, 
digital health applications have become of particular interest and importance since 
the onset of the ongoing Covid19-pandemic. 
To summarize, well-designed, high quality studies are needed to confirm the 
beneficial effects of MBIs on psychological distress and dyspnea, but also to further 
investigate the effects on perceived and psychophysiological stress. This is crucial 
to enable an evidence-based use of MBIs in clinical settings. 
 
The presented pilot and feasibility randomized controlled trial will investigate a 
mindfulness-based ecological momentary intervention (EMI) applicable in the daily 
life of COPD patients. The intervention is adapted to patients’ needs and limitations, 
which were assessed in our previous study and were found to be crucial for patients’ 
adherence. This will be the first study to examine an app-based mindfulness EMI for 
COPD patients.  
The study will use an ecological momentary assessment (EMA) design, which 
allows real-time measures in the patients’ daily life. Previous research showed EMA 
to be more valid and sensitive in investigating dynamic psychological aspects (e.g. 
affective variables). Moreover, it was able to detect therapeutic effects earlier and 
minimized retrospective biases compared to standard questionnaire assessments 
(Ebner-Priemer & Trull, 2009). 
The delivery via an app was chosen to improve adherence and to suit patients’ 
difficulties regarding mobility. Additionally, this allows to provide a personalized 
intervention, as different exercises can be chosen based on patients’ preferences 
and needs. Furthermore, mobile health is an emerging and promising field, which 
is both economic and feasible when used in health care. 
In addition, as personalized medicine is a growing field of interest and holds 
great potential, the presented study aims to identify treatable traits and patients 
who benefit most from the intervention. 
Finally, 
this 
study 
will 
examine 
the 
effects 
of 
mindfulness 
on 
psychophysiological stress markers (e.g. heart rate variability), which play an 
important role in COPD (Andreas, Haarmann, Klarner, Hasenfuß, & Raupach, 2014). 
It is well known that physiological and psychological stress symptoms can be 
reduced by MBIs (Pascoe et al., 2017). Yet, this effect has poorly been studied in 
COPD patients to date. 
OBJECTIVES 
• 
Is a brief digital mindfulness-based intervention feasible for stable COPD 
patients? 

 
 
 
 
 
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• 
Can a brief digital mindfulness-based intervention reduce psychological distress 
in stable, but psychologically distressed, COPD patients (using the “Hospital 
Anxiety and Depression Scale”)? 
• 
What are the immediate effects of a short mindfulness exercise for stable COPD 
patients on dyspnea, acute perceived stress, relaxation, affect and oxygen 
saturation? 
• 
What are the effects of daily short mindfulness practice for stable COPD patients 
on patients’ stress level and stress reactivity (heart rate variability, 
electrodermal activity), when being exposed to a cognitive stressor (Stroop-
test)? 
• 
What are the effects of daily short mindfulness practice for stable COPD patients 
on patients’ dealing with the exposure to a cognitive stressor (Stroop-Test)? Are 
there effects on anxiety, panic, acute perceived stress, relaxation, affect and 
oxygen saturation? 
• 
What are the intermediate and long-term effects of daily short mindfulness 
practice for stable COPD patients on health-related quality of life, health status 
impairment, 
fatigue, 
breathlessness 
catastrophizing, 
perceived 
stress, 
mindfulness and self-compassion? 
• 
Does the compliance regarding medication differ between the groups due to 
the intervention? 
• 
How do patients experience the intervention? 
• 
How often do patients meditate by using the app? How long? When? Do they 
prefer a specific mindfulness exercise?  
• 
Which patients benefit the most from the intervention (moderating factors, e.g. 
age)? 
• 
Do mindfulness and self-compassion mediate the intermediate and long-term 
effects on psychological distress? 
DESIGN / PHASE 
• 
pilot and feasibility study 
• 
randomized controlled trial including follow-up 
• 
two treatment arms: intervention + treatment as usual (TAU) vs. waitlist (TAU) 
• 
ecological momentary assessment (EMA) study 
• 
ecological momentary intervention (EMI) study (app-based) 
• 
prospective and experimental 
• 
mixed methods analysis 
• 
multi-centred 
STUDY PLANNED 
DURATION 
6 months (8 weeks intervention + follow-up) 
CENTER(S)/ 
COUNTRY(IES)  
Respiratory unit of the “Klinik Ottakring”, Vienna, Austria 
Respiratory unit of the “Klinik Floridsdorf”, Vienna, Austria 
PATIENTS / 
GROUPS 
1. Intervention group: mindfulness exercises + TAU 
2. Waitlist control group: TAU 
 30 COPD patients (15 patients in each group)  

 
 
 
 
 
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 screening of all eligible patients during survey period, inclusion 
of all eligible interested patients  
 single blinding (of assessors) 
 equal treatment allocation via block randomization 
ETHICS 
• 
patients’ written informed consent 
• 
pseudonymisation of patients: 
o 
Patients’ personal data is noted on 2 documents: the patients’ information 
(name, birth date, code) and the patients’ contact details (name, birth date, 
address, phone number, email address, code). These documents are safely 
stored in a locked cupboard in the Klinik Ottakring, Vienna, Austria. Only 
members of the research team have access to the cupboard’s key. 
o 
After the screening, the patient is given a unique reference code 
(continuous numerical code starting from 01). In the following, only this 
numerical code will be used to allocate the data to the patient. 
o 
The allocation of the patients’ personal data to their numerical code will 
only be possible using either the patients’ information or the patients’ 
contact details. 
• 
pseudonymised data analysis 
• 
provision of mindfulness intervention to waitlist control group after study 
completion 
• 
examination and agreement by the ethics committee of the “Wiener 
Krankenanstaltenverbund”, Vienna, Austria 
 
INCLUSION 
CRITERIA 
• 
spirometry confirmed (FEV1<80%) COPD diagnosis 
• 
psychological distress (as assessed by the Hospital Anxiety and Depression 
Scale): 
o 
HADS-A ≥ 8 OR 
o 
HADS-D ≥ 8 OR 
o 
HADS total score ≥ 16 
• 
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 
EXCLUSION 
CRITERIA 
• 
auditory impairment  
• 
active asthma diagnosis 
• 
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 
STUDY PERIODS 
 individual mindfulness practice at home (baseline – 8 weeks) 
 Follow-up (3 months and 6 months) 

 
 
 
 
 
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MEASUREMENTS 
(baseline, 4 weeks, 8 weeks, 4 months, 6 months)  
psychological distress, perceived stress, health related quality of life, health status 
impairment, fatigue, mindfulness, self-compassion, breathlessness catastrophizing 
(baseline, 4 weeks, 8 weeks, 4 months, 6 
months) heart rate variability, electrodermal activity (before, during and after the 
conduction of a cognitive task (Stroop-test)) 
(daily for intervention period of 8 weeks)
• 
pre-meditation (event-based): dyspnea, acute perceived stress, relaxation, 
anxiety, depression, happiness, oxygen saturation (pulse oximeter) 
• 
post-meditation (event-based): dyspnea, acute perceived stress, relaxation, 
anxiety, depression, happiness, oxygen saturation (pulse oximeter) 
STUDY TIME-LINE 
• 
pulmonary ambulances of the Klinik Ottakring and Klinik Floridsdorf 
• 
previously hospitalized COPD patients in the Klinik Ottakring and Klinik 
Floridsdorf 
• 
invitation to the intervention via telephone call or personal invitation in the 
pulmonary ambulance (flyer and oral information) 
• 
invitation to the intervention via posting a flyer on social media (Facebook) 
• 
screening for inclusion and exclusion criteria 
Day 0: 
• 
Informed consent  
• 
Baseline data collection  
o 
Sociodemographic and medical data 
o 
Paper-pencil data collection 
o 
Chronic stress (collection of hair sample) 
o 
Psychophysiological data collection 
Day 1: 
• 
Introductory and learning phase (face-to-face) 
• 
Installation and testing of app, explanation of intervention, conduction of all 
mindfulness exercises in the presence of study investigator 
• 
From now on: Individual daily meditation + daily EMA data collection 
• 
Possibility of consulting the study coordinator in person and if necessary, 
discussing/solving problems in period 1 
Intermediate (4 weeks): 
• 
Paper-pencil data collection (+ hospitalization and exacerbation rate) 
• 
Psychophysiological data collection  
Exit (8 weeks): 
• 
Paper-pencil data collection (+ hospitalization rate, exacerbation rate, 
credibility/expectancy) 
• 
Psychophysiological data collection  
• 
Short exit-interview (telephone) 

 
 
 
 
 
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Follow-up 1 (4 months): 
• 
Paper-pencil data collection (+ hospitalization and exacerbation rate) 
• 
Psychophysiological data collection  
• 
Chronic stress (collection of hair sample) 
Follow-up 2 (6 months): 
• 
Paper-pencil data collection (+ hospitalization and exacerbation rate) 
• 
Psychophysiological data collection  
• 
Chronic stress (collection of hair sample) 
• 
Post-monitoring interview 
INTERVENTION 
• 
App provides 4 audio-files of guided mindfulness exercises  
• 
Length: 10-15 minutes  
• 
Mindfulness exercises: 
o 
Body awareness meditation (Body-scan) 
o 
Sitting meditation: awareness of the heartbeat 
o 
Sitting meditation: awareness of the body 
o 
Sitting meditation: awareness of sounds 
Dose: Patients can choose individually between exercises 
Daily practice: instructions to practice at least once each day, either in the morning 
or the evening (patients choose in the beginning if they prefer meditating in the 
morning or in the evening) 
Additional practice: additional meditations are possible and encouraged (it is 
advised to practice when experiencing respiratory problems, feeling distressed, 
feeling stressed or whenever considered to be beneficial) 
CONTROL 
CONDITION 
Waitlist control group (receiving treatment as usual during the intervention period) 
(same collection of psychophysiological, psychological and biological data, except 
for the intervention-related measures right before and after the intervention) 
INCENTIVES 
Weekly “checking-in calls” 
CONCOMITANT 
MEDICATION 
Allowed (but must be monitored) 
PRIMARY 
OUTCOME 
VARIABLES 
 (exit interview, drop-out-rate) 
• 
Psychological distress (Hospital Anxiety and Depression Scale) 
SECONDARY 
OUTCOME 
VARIABLES 
• 
Acute perceived stress (visual analogue scale) 
• 
Dyspnea (Borg Dyspnea Scale) 
• 
Relaxation (Likert scale based on MDBF) 
• 
Affect (anxiety, depression, happiness; based on HADS) 
• 
Oxygen saturation in blood (Pulse Oximeter) 

 
 
 
 
 
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• 
Heart rate variability, heart rate (chest belt) 
• 
Electrodermal activity (EDA-sensors) 
• 
Chronic stress (hair-cortisol) 
• 
Chronic stress (Perceived Stress Scale) 
• 
Health related quality of life (Chronic Respiratory Questionnaire) 
• 
Health status impairment (COPD-Assessment Test) 
• 
Fatigue (Multidimensional Fatigue Inventory) 
• 
Mindfulness (German Version of Freiburg Mindfulness Inventory – Freiburger 
Fragebogen zur Achtsamkeit) 
• 
Self-compassion (Self Compassion Scale) 
• 
Breathlessness Catastrophizing (Breathlessness Catastrophizing Scale) 
• 
Compliance regarding medication  
• 
Perception of exacerbations (exit interview) 
• 
Hospitalization rate  
• 
Frequency and intensity of exacerbations  
STATISTICAL 
METHODOLOGY  
It is hypothesized that the digital MBI will be feasible in the ambulant setting. 
Furthermore, it is assumed that the digital intervention will reduce psychological 
distress. 
The feasibility of the study will be examined using descriptive analyses, looking 
deeper into drop-out-rates, recruitment, adherence and patients’ personal factors. 
Groups (intervention vs. waitlist) will be compared regarding subjective variables 
(e.g. psychological distress), biological variables (hair cortisol levels), and 
physiological responses of the autonomous nervous system (heart rate variability, 
electrodermal activity) to the mental stressor using analyses of variance (ANOVAs) 
with repeated measurement. These analyses test for main effects of time (within 
subject factor) and group (between subject factor) as well as their interaction effect. 
In case the requirements of ANOVAs are not met, a non-parametric pendant will be 
used. Furthermore, mediating (e.g. mindfulness) and moderating (e.g. age, gender, 
disease severity) effects will be analysed.  
For the analysis of the EMA data in the intervention group, multilevel modelling will 
be used to fit the nested data structure. A two-level model (level 1 = within persons, 
level 2 = between persons) will be used, with all the assessed subjective variables 
(e.g. momentary stress) nested on level 1 due to multiple measurements. Pre-post 
effects of the assessed subjective variables will examine the immediate effects of 
the MBI.  
Telephone exit interviews will be recorded and analysed using thematic analysis and 
a mixed methods approach. 
DATA 
MANAGEMENT 
• 
 As data are collected on different sites by student research 
assistants, data will firstly be transported to the Department of Clinical and 
Health Psychology, University of Vienna, Austria. There, data will be digitalized. 

 
 
 
 
 
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For this process, data will be safely stored in a locked cupboard in the 
Department of Clinical and Health Psychology, University of Vienna, Austria. 
Only members of the research team have access to the key. 
• 
 The study coordinator will transport the 
physical data safely to the Klinik Ottakring, Vienna, Austria, where the data is 
finally stored in a locked cupboard. Only members of the research team have 
access to the key. 
• 
 Digital data will be stored on the share server of the 
research team led by Prof. Urs Markus Nater (University of Vienna, Austria). A 
project folder “39 SPIROMIND” was created for the data storage. Each person’s 
access to the folder must be approved by Prof. Urs Markus Nater and must be 
activated by the department’s IT team. Only members of the SPIROMIND 
research team have access to the folder. Additionally, data will be stored on the 
study coordinator’s server of the Klinik Ottakring, Vienna, Austria, and on the 
study coordinator’s server of the Department of Clinical and Health Psychology, 
University of Vienna, Austria. 
• 
Data will be analysed using the software IBM SPSS Statistics, version 
24, and the software R, version 3.4.2. 
• 
Data are stored on the study’s private account of the software 
MovisensXS. Only members of the research team have access to the account. 
• 
 Data will be exported from MovisensXS and stored on the share 
server of the research team led by Prof. Urs Markus Nater (University of Vienna, 
Austria). A project folder “39 SPIROMIND” was created for the data storage. Each 
person’s access to the folder must be approved by Prof. Urs Markus Nater and 
must be activated by the department’s IT team. Only members of the 
SPIROMIND research team have access to the folder. Additionally, data will be 
stored on the study coordinator’s server of the Klinik Ottakring, Vienna, Austria, 
and on the study coordinator’s server of the Department of Clinical and Health 
Psychology, University of Vienna, Austria. 
• 
Data will be analysed using the software IBM SPSS Statistics, version 
24, the software R, version 3.4.2, and HLM. 
• 
Data will be exported from the devices using the Movisens Data 
Manager. This will be conducted by the student research assistants.
• 
 Data will then be stored on the share server of the research 
team led by Prof. Urs Markus Nater (University of Vienna, Austria). A project 
folder “39 SPIROMIND” was created for the data storage. Each person’s access 
to the folder must be approved by Prof. Urs Markus Nater and must be activated 
by the department’s IT team. Only members of the SPIROMIND research team 
have access to the folder. Additionally, data will be stored on the study 
coordinator’s server of the Klinik Ottakring, Vienna, Austria, and on the study 
coordinator’s server of the Department of Clinical and Health Psychology, 
University of Vienna, Austria. 
• 
Data will be analysed using the software Movisens Data Analyser (Base 
+ Cardio/HRV), IBM SPSS Statistics, version 24, and the software R, version 3.4.2. 
• 
 As data are collected on different sites by student research 
assistants, data will firstly be transported to the Department of Clinical and 

 
 
 
 
 
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Health Psychology, University of Vienna, Austria. There, data will be safely 
stored in a locked cupboard in the Department of Clinical and Health 
Psychology, University of Vienna, Austria, until data will be analysed. Only 
members of the research team have access to the key.  
• 
 A member of the research team will safely transport the 
data to the biochemical laboratory of the Faculty of Psychology, Vienna, Austria, 
where the data will be analysed by researchers unrelated to the SPIROMIND 
study. The biochemical laboratory ensures safe storage of the data.  
• 
 The study coordinator will transport the 
biometric data safely to the Klink Ottakring, Vienna, Austria, where the data is 
finally stored in a locked cupboard. Only members of the research team have 
access to the key. 
• 
 Digital data will be stored on the share server of the 
research team led by Prof. Urs Markus Nater (University of Vienna, Austria). A 
project folder “39 SPIROMIND” was created for the data storage. Each person’s 
access to the folder must be approved by Prof. Urs Markus Nater and must be 
activated by the department’s IT team. Only members of the SPIROMIND 
research team have access to the folder. Additionally, data will be stored on the 
study coordinator’s server of the Klinik Ottakring, Vienna, Austria, and on the 
study coordinator’s server of the Department of Clinical and Health Psychology, 
University of Vienna, Austria. 
• 
Digital data will be analysed using the software IBM SPSS Statistics, 
version 24, and the software R, version 3.4.2. 
• 
 Data will be collected using a recorder.  
• 
: Data (audio-files) will be stored on the share server of the research 
team led by Prof. Urs Markus Nater (University of Vienna, Austria). A project 
folder “39 SPIROMIND” was created for the data storage. Each person’s access 
to the folder must be approved by Prof. Urs Markus Nater and must be activated 
by the department’s IT team. Only members of the SPIROMIND research team 
have access to the folder. Additionally, data will be stored on the study 
coordinator’s server of the Klinik Ottakring, Vienna, Austria, and on the study 
coordinator’s server of the Department of Clinical and Health Psychology, 
University of Vienna, Austria. 
• 
Data will be analysed using the softwares f4transcript and f4analyse. 
DATA SECURITY 
All WIGEV external members of the research team consented to sign the 
“datenschutzrechtliche Verpflichtungserklärung des WIGEV”. The study coordinator 
of the Karl Landsteiner Institute for Lung Research and Pneumological Oncology 
stores these documents in the Klinik Ottakring. 
 
 

 
 
 
 
 
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REFERENCES 
 
Adam, E. K., Quinn, M. E., Tavernier, R., McQuillan, M. T., Dahlke, K. A., & Gilbert, K. E. (2017). Diurnal cortisol slopes and 
mental and physical health outcomes: A systematic review and meta-analysis. Psychoneuroendocrinology, 83, 25–41. 
https://doi.org/10.1016/j.psyneuen.2017.05.018 
Andenæs, R., Kalfoss, M. H., & Wahl, A. K. (2006). Coping and psychological distress in hospitalized patients with chronic 
obstructive pulmonary disease. Heart and Lung: Journal of Acute and Critical Care, 35, 46–57. 
https://doi.org/10.1016/j.hrtlng.2005.09.009 
Andreas, S., Haarmann, H., Klarner, S., Hasenfuß, G., & Raupach, T. (2014). Increased Sympathetic Nerve Activity in COPD is 
Associated with Morbidity and Mortality. Lung, 192, 235–241. https://doi.org/10.1007/s00408-013-9544-7 
Atlantis, E., Fahey, P., Cochrane, B., & Smith, S. (2013). Bidirectional associations between clinically relevant depression or 
anxiety and COPD: A systematic review and meta-analysis. CHEST, 144, 766–777. https://doi.org/10.1378/chest.12-
1911 
Blakemore, A., Dickens, C., Guthrie, E., Bower, P., Kontopantelis, E., Afzal, C., & Coventry, P. A. (2014). Depression and anxiety 
predict health-related quality of life in chronic obstructive pulmonary disease: Systematic review and meta-analysis. 
International Journal of COPD, 9, 501–512. https://doi.org/10.2147/COPD.S58136 
Bohlmeijer, E., Prenger, R., Taal, E., & Cuijpers, P. (2010). The effects of mindfulness-based stress reduction therapy on mental 
health of adults with a chronic medical disease: A meta-analysis. Journal of Psychosomatic Research, 68, 539–544. 
https://doi.org/10.1016/j.jpsychores.2009.10.005 
Cafarella, P. A., Effing, T. W., Barton, C., Ahmed, D., & Frith, P. A. (2013). Management of depression and anxiety in COPD. 
European Respiratory Monograph, 59, 144–163. https://doi.org/10.1183/1025448x.10012112 
Chan, R. R., Giardino, N., & Llarson, J. (2015). A pilot study: Mindfulness meditation intervention in COPD. International 
Journal of COPD, 10, 445–454. https://doi.org/10.2147/COPD.S73864 
Chrousos, G. P. (2009). Stress and disorders of the stress system. Nature Reviews Endocrinology, 5, 374–381. 
https://doi.org/10.1038/nrendo.2009.106 
Cillessen, L., Johannsen, M., Speckens, A. E. M., & Zachariae, R. (2019). Mindfulness-based interventions for psychological 
and physical health outcomes in cancer patients and survivors: A systematic review and meta-analysis of randomized 
controlled trials. Psycho-Oncology, 28, 2257–2269. https://doi.org/10.1002/pon.5214 
Ebner-Priemer, U. W., & Trull, T. J. (2009). Ecological Momentary Assessment of Mood Disorders and Mood Dysregulation. 
Psychological Assessment, 21, 463–475. https://doi.org/10.1037/a0017075 
Farver-Vestergaard, I., O’Connor, M., Smith, N. C., Løkke, A., Bendstrup, E., & Zachariae, R. (2018). Tele-delivered mindfulness-
based cognitive therapy in chronic obstructive pulmonary disease: A mixed-methods feasibility study. Journal of 
Telemedicine and Telecare, 25, 468–475. https://doi.org/10.1177/1357633X18780563 
Farver-Vestergaard, I., O’Toole, M. S., O’Connor, M., Lokke, A., Bendstrup, E., Basdeo, S. A., … Zachariae, R. (2018). 
Mindfulness-based cognitive therapy in COPD: A cluster randomised controlled trial. European Respiratory Journal, 51, 
1702082. https://doi.org/10.1183/13993003.02082-2017 
Glaser, R., & Kiecolt-Glaser, J. K. (2005). Stress-induced immune dysfunction: Implications for health. Nature Reviews 
Immunology, 5, 243–251. https://doi.org/ 10.1038/nri1571 
Hazlett-Stevens, H., Singer, J., & Chong, A. (2019, August 8). Mindfulness-Based Stress Reduction and Mindfulness-Based 
Cognitive Therapy with Older Adults: A Qualitative Review of Randomized Controlled Outcome Research. Clinical 
Gerontologist, 42, 347–358. https://doi.org/10.1080/07317115.2018.1518282 
Matte, D. L., Pizzichini, M. M. M., Hoepers, A. T. C., Diaz, A. P., Karloh, M., Dias, M., & Pizzichini, E. (2016). Prevalence of 
depression in COPD: A systematic review and meta-analysis of controlled studies. Respiratory Medicine, 117, 154–161. 
https://doi.org/10.1016/j.rmed.2016.06.006 
Mularski, R. A., Munjas, B. A., Lorenz, K. A., Sun, S., Robertson, S. J., Schmelzer, W., … Shekelle, P. G. (2009). Randomized 
controlled trial of mindfulness-based therapy for dyspnea in chronic obstructive lung disease. The Journal of Alternative 
and Complementary Medicine, 15, 1083–1090. https://doi.org/10.1089/acm.2009.0037 
Panagioti, M., Scott, C., Blakemore, A., & Coventry, P. A. (2014). Overview of the prevalence, impact, and management of 
depression and anxiety in chronic obstructive pulmonary disease. International Journal of COPD, 9, 1289–1306. 
https://doi.org/10.2147/COPD.S72073 

 
 
 
 
 
Clinical Study Protocol 
Page 16 of 16 
SPIROMIND-STUDY_V2.0_26.04.21 
 
 
 
 
Pascoe, M. C., Thompson, D. R., Jenkins, Z. M., & Ski, C. F. (2017). Mindfulness mediates the physiological markers of stress: 
Systematic 
review 
and 
meta-analysis. 
Journal 
of 
Psychiatric 
Research, 
95, 
156–178. 
https://doi.org/10.1016/j.jpsychires.2017.08.004 
Perkins-Porras, L., Riaz, M., Okekunle, A., Zhelezna, S., Chakravorty, I., & Ussher, M. (2018). Feasibility study to assess the 
effect of a brief mindfulness intervention for patients with chronic obstructive pulmonary disease: A randomized 
controlled trial. Chronic Respiratory Disease, 15, 400–410. https://doi.org/10.1177/1479972318766140 
Pumar, M. I., Gray, C. R., Walsh, J. R., Yang, I. A., Rolls, T. A., & Ward, D. L. (2014). Anxiety and depression-Important 
psychological comorbidities of COPD. Journal of Thoracic Disease, 6, 1615–1631. https://doi.org/10.3978/j.issn.2072-
1439.2014.09.28 
Singh, S., Verma, S. K., Kumar, S., Ahmad, M. K., Nischal, A., Singh, S. K., & Dixit, R. K. (2018). Correlation of severity of chronic 
obstructive 
pulmonary 
disease 
with 
potential 
biomarkers. 
Immunology 
Letters, 
196, 
1–10. 
https://doi.org/10.1016/j.imlet.2018.01.004 
Tan, S.-B., Liam, C.-K., Pang, Y.-K., Leh-Ching Ng, D., Wong, T.-S., Wei-Shen Khoo, K., … Chai, C.-S. (2019). The effect of 20-
minute mindful breathing on the rapid reduction of dyspnea at rest in patients with lung diseases: A randomized 
controlled 
trial. 
Journal 
of 
Pain 
and 
Symptom 
Management, 
57, 
802–808. 
https://doi.org/10.1016/j.jpainsymman.2019.01.009 
Usmani, Z., Chahhoud, K., Esterman, A., & Smith, B. (2018). Systematic meta-analysis of pharmacological and psychological 
interventions for the treatment of anxiety in patients with chronic obstructive pulmonary disease. Archives of 
Psychology, 2, 1–16. https://doi.org/10.31296/aop.v2i7.77 
Van Gestel, A., Kohler, M., & Clarenbach, C. (2012). Sympathetic overactivity and cardiovascular disease in patients with 
chronic obstructive pulmonary disease (COPD). Discovery Medicine, 14, 359–368. 
Willgoss, T. G., & Yohannes, A. M. (2013). Anxiety disorders in patients with COPD: A systematic review. Respiratory Care, 58, 
858–866. https://doi.org/10.4187/respcare.01862