Mindfulness-based Interventions in COPD Patients

Chronic Obstructive Pulmonary Disease Exacerbation Clinical Trial

— SPIROMIND  

Official title:

A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769505
• Other study ID #: SPIROMIND 39
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 27, 2023

Study information

• Verified date: March 2024
• Source: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 27, 2023
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease Exacerbation
• Disease Progression
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• digital mindfulness-based intervention (MBI)
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.

Locations

Country	Name	City	State
Austria	Klinik Ottakring	Vienna

Sponsors (5)

Lead Sponsor	Collaborator
Karl Landsteiner Institute for Lung Research and Pneumological Oncology	Klinik Floridsdorf, Klinik Ottakring, Therme Wien Med (Ambulant Pulmonary Rehabilitation), University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline - 4 weeks
Primary	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	baseline - 8 weeks
Primary	Patient's experiences with the digital MBI	patients' experiences assessed in the exit interview (qualitative and quantitative data)	8 weeks
Secondary	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	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Health related quality of life	Chronic Respiratory Questionnaire (CRQ-SAS; German version Schünemann et al., 2003), scores: 20-140, higher scores indicate improvement	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Health status impairment	COPD Assessment Test (CAT; Jones et al., 2009), scores 0-40, lower scores indicate improvement	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Fatigue	Multidimensional Fatigue Inventory (MFI-20; German version Schwarz, Krauss, & Hinz, 2003), scores 0-80, items have different polarity	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Mindfulness	Freiburger Mindfulness Inventory short form (FMI short form; Walach, Buchheld, Buttenmüller, Kleinknecht, & Schmidt, 2006), scores 0-42, higher scores indicate improvement	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	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	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	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	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Stress reactivity	the reactivity to stress assessed via examining heart rate variability (RMSSD) during the exposure to a mental stressor (stroop test)	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Stress reactivity	the reactivity to stress assessed via examining skin conductance level during the exposure to a mental stressor (stroop test)	baseline, 4 weeks, 8 weeks, 4 months, 6 months
Secondary	Hair cortisol	concentration of hair cortisol (as biomarker for chronic stress)	baseline, 8 weeks, 4 months, 6 months
Secondary	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	baseline, 4 months, 6 months