Mindfulness-based Interventions in COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease Exacerbation
- Interventions
- Behavioral: digital mindfulness-based intervention (MBI)
- Registration Number
- NCT04769505
- Lead Sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological Oncology
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group digital mindfulness-based intervention (MBI) Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual.
- Primary Outcome Measures
Name Time Method Psychological distress 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 8 weeks patients' experiences assessed in the exit interview (qualitative and quantitative data)
- Secondary Outcome Measures
Name Time Method Breathlessness catastrophizing baseline, 4 weeks, 8 weeks, 4 months, 6 months 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
Hair cortisol baseline, 8 weeks, 4 months, 6 months concentration of hair cortisol (as biomarker for chronic stress)
Chronic stress baseline, 4 weeks, 8 weeks, 4 months, 6 months assessed by Perceived Stress Scale (PSS-10; Cohen \& Williamson, 1988; German version Klein et al., 2016), scores 0-40, lower scores indicate improvement
Health status impairment baseline, 4 weeks, 8 weeks, 4 months, 6 months COPD Assessment Test (CAT; Jones et al., 2009), scores 0-40, lower scores indicate improvement
Fatigue baseline, 4 weeks, 8 weeks, 4 months, 6 months Multidimensional Fatigue Inventory (MFI-20; German version Schwarz, Krauss, \& Hinz, 2003), scores 0-80, items have different polarity
Self-compassion baseline, 4 weeks, 8 weeks, 4 months, 6 months 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
Psychological distress baseline, 4 months, 6 months Hospital Anxiety and Depression Scale (HADS; Zigmond \& Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement
Health related quality of life baseline, 4 weeks, 8 weeks, 4 months, 6 months Chronic Respiratory Questionnaire (CRQ-SAS; German version Schünemann et al., 2003), scores: 20-140, higher scores indicate improvement
Mindfulness baseline, 4 weeks, 8 weeks, 4 months, 6 months Freiburger Mindfulness Inventory short form (FMI short form; Walach, Buchheld, Buttenmüller, Kleinknecht, \& Schmidt, 2006), scores 0-42, higher scores indicate improvement
Stress reactivity baseline, 4 weeks, 8 weeks, 4 months, 6 months the reactivity to stress assessed via examining skin conductance level during the exposure to a mental stressor (stroop test)
Trial Locations
- Locations (1)
Klinik Ottakring
🇦🇹Vienna, Austria