Mindfulness-based Interventions in COPD Patients

  • STATUS
    Recruiting
  • End date
    Feb 27, 2022
  • participants needed
    30
  • sponsor
    Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Updated on 27 June 2021

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.

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.

Details
Condition Chronic Obstructive Pulmonary Disease Exacerbation
Treatment digital mindfulness-based intervention (MBI)
Clinical Study IdentifierNCT04769505
SponsorKarl Landsteiner Institute for Lung Research and Pneumological Oncology
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
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