Mindfulness-based Interventions in COPD Patients (SPIROMIND)

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease Exacerbation
• Intervention / Treatment: Behavioral: digital mindfulness-based intervention (MBI)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Klinik Ottakring

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual.	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.
No Intervention: Wait list control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Patient's experiences with the digital MBI	patients' experiences assessed in the exit interview (qualitative and quantitative data)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
Hair cortisol	concentration of hair cortisol (as biomarker for chronic stress)	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	baseline, 4 months, 6 months

Collaborators and Investigators

• Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
• Collaborators: Klinik Ottakring; University of Vienna; Klinik Floridsdorf; Therme Wien Med (Ambulant Pulmonary Rehabilitation)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 5, 2022
• Study Completion (Actual): March 27, 2023

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Disease Progression; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SPIROMIND 39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No