Mindfulness-based Interventions in COPD Patients (SPIROMIND)

• ClinicalTrials.gov Identifier: NCT04769505
• Recruitment Status: Recruiting
• First Posted: February 24, 2021
• Last Update Posted: June 18, 2021
• Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
• Collaborators: University of Vienna; Klinik Ottakring; Klinik Floridsdorf
• Information provided by (Responsible Party): Georg-Christian Funk, Karl Landsteiner Institute for Lung Research and Pneumological Oncology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease Exacerbation	Behavioral: digital mindfulness-based intervention (MBI)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Pilot Randomized Controlled Trial to Examine the Feasibility and Effectiveness of a Brief Digital Mindfulness-based Intervention for COPD Patients
• Actual Study Start Date: April 1, 2021
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: February 2022

Arms and Interventions

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 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, either in the morning or in the evening, and additionally whenever they desire to. They can choose individually between the exercises.
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 their study completion.

Outcome Measures

Primary Outcome Measures :

1. Psychological distress [ Time Frame: baseline - 4 weeks ]
   Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983; German version Herrmann-Lingen et al., 2011), scores: 0-42, lower scores indicate improvement
2. Psychological distress [ Time Frame: 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
3. Patient's experiences with the digital MBI [ Time Frame: 8 weeks ]
   patients' experiences assessed in the exit interview (qualitative and quantitative data), this indicates the feasibility of the intervention

Secondary Outcome Measures :

1. Chronic stress [ Time Frame: 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
2. Health related quality of life [ Time Frame: 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
3. Health status impairment [ Time Frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months ]
   COPD Assessment Test (CAT; Jones et al., 2009), scores 0-40, lower scores indicate improvement
4. Fatigue [ Time Frame: 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
5. Mindfulness [ Time Frame: 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
6. Self-compassion [ Time Frame: 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
7. Breathlessness catastrophizing [ Time Frame: 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
8. Stress reactivity [ Time Frame: baseline, 4 weeks, 8 weeks, 4 months, 6 months ]
   the reactivity to stress assessed via examining heart rate variability (RMSSD) during the exposure to a mental stressor (stroop test)
9. Stress reactivity [ Time Frame: 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)
10. Hair cortisol [ Time Frame: baseline, 8 weeks, 4 months, 6 months ]
    concentration of hair cortisol (as biomarker for chronic stress)
11. Psychological distress [ Time Frame: 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

Eligibility Criteria

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

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

Exclusion Criteria:

1. auditory impairment
2. active asthma diagnosis
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

Contacts and Locations

Contacts

Contact: Georg-Cristian Funk, M.D.; +43 1 49150 2201; georg-christian.funk@gesundheitsverbund.at

Contact: Hannah Tschenett, MSc BSc; +43 6606053628; hannah.tschenett@univie.ac.at

Locations

Austria

Klinik Ottakring; Recruiting

Vienna, Austria, 1160

Contact: Georg-Christian Funk, M.D. +43 1 49150 2201 georg-christian.funk@gesundheitsverbund.at

Contact: Hannah Tschenett, BSc MSc hannah.tschenett@univie.ac.at

Sponsors and Collaborators

Karl Landsteiner Institute for Lung Research and Pneumological Oncology

University of Vienna

Klinik Ottakring

Klinik Floridsdorf

  Study Documents (Full-Text)

Documents provided by Georg-Christian Funk, Karl Landsteiner Institute for Lung Research and Pneumological Oncology:

Study Protocol  [PDF] April 26, 2021

More Information

• Responsible Party: Georg-Christian Funk, Assoc.-Prof. Georg-Christian Funk, M.D., Karl Landsteiner Institute for Lung Research and Pneumological Oncology
• ClinicalTrials.gov Identifier: NCT04769505
• Other Study ID Numbers: SPIROMIND 39
• First Posted: February 24, 2021
• Last Update Posted: June 18, 2021
• Last Verified: June 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes