An interventional study of digital mindfulness-based intervention (MBI) in Chronic Obstructive Pulmonary Disease Exacerbation, sponsored by Karl Landsteiner Institute for Lung Research and Pneumological Oncology. Completed at 1 site in Austria. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-03-18.
Sponsored by Karl Landsteiner Institute for Lung Research and Pneumological Oncology · Not applicable, Interventional, and Treatment
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 30 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Karl Landsteiner Institute for Lung Research and Pneumological Oncology is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
(*) 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.
Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual.
Behavioral: digital mindfulness-based intervention (MBI)
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.
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.
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
Time frame: 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
Time frame: baseline - 8 weeks
Patient's experiences with the digital MBI
patients' experiences assessed in the exit interview (qualitative and quantitative data)
Time frame: 8 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
Hair cortisol
concentration of hair cortisol (as biomarker for chronic stress)
Time frame: 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
Time frame: baseline, 4 months, 6 months
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Karl Landsteiner Institute for Lung Research and Pneumological Oncology