Clinical trial NCT04769505: Mindfulness-based Interventions in COPD Patients
Official title: A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
Lead sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Sponsor class: OTHER
Collaborators: name: University of Vienna
name: Klinik Ottakring
name: Klinik Floridsdorf
name: Therme Wien Med (Ambulant Pulmonary Rehabilitation)
First posted: 2021-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion criteria:

1. spirometry confirmed (FEV1\<80%) COPD diagnosis
2. psychological distress (as assessed by the Hospital Anxiety and Depression Scale): HADS-A ≥ 8 OR HADS-D ≥ 8 OR\*
3. age ≥ 40 years
4. ability to understand German
5. physical and mental capability to attend the intervention, judged by the treating physician
6. life expectancy \> 6 months as judged by treating physician
7. ability to use a smartphone
8. 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.)

Exclusion Criteria:

1. auditory impairment
2. 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)\*\*
3. any other known severe comorbidities such as heart failure (LVF\<35%), uncontrolled diabetes, concomitant cancer, stroke, unstable coronary heart disease, respiratory failure
4. history of/current severe psychological disorder (e.g. schizophrenia, severe cognitive impairment)
5. current acute exacerbation of COPD
6. any other relevant acute health crisis interfering with the study intervention (e.g. Covid-19)
7. receiving any psychosocial treatment (e.g. psychotherapy)
8. 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.

Primary outcomes:
measure: Psychological distress
timeFrame: baseline - 4 weeks
measure: Psychological distress
timeFrame: baseline - 8 weeks
measure: Patient's experiences with the digital MBI
timeFrame: 8 weeks
Secondary outcomes:
measure: Chronic stress
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Health related quality of life
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Health status impairment
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Fatigue
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Mindfulness
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Self-compassion
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Breathlessness catastrophizing
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Stress reactivity
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Stress reactivity
timeFrame: baseline, 4 weeks, 8 weeks, 4 months, 6 months
measure: Hair cortisol
timeFrame: baseline, 8 weeks, 4 months, 6 months
measure: Psychological distress
timeFrame: baseline, 4 months, 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Ottakring
Study officials:
References: