Mindfulness-based Interventions in COPD Patients

NCT04769505 | Completed

• 1 other identifier: SPIROMIND 39
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Chronic stress

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Health related quality of life

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Health status impairment

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Fatigue

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

• Mindfulness

  baseline, 4 weeks, 8 weeks, 4 months, 6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants receive a digital mindfulness-based intervention (MBI) + treatment as usual.

Behavioral: digital mindfulness-based intervention (MBI)

Wait list control group

NO INTERVENTION

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.

Interventions

digital mindfulness-based intervention (MBI) BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.)

You may not qualify if:

• auditory impairment
• 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
• (\*\*) 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.

Sponsors & Collaborators

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

Study Sites (1)

Klinik Ottakring

Vienna, 1160, Austria

Location

Related Publications (1)

• Tschenett H, Vafai-Tabrizi F, Zwick RH, Valipour A, Funk GC, Nater UM. Digital mindfulness-based intervention for people with COPD - a multicentre pilot and feasibility RCT. Respir Res. 2025 May 26;26(1):199. doi: 10.1186/s12931-025-03243-4.

  PMID: 40420253 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. Georg-Christian Funk, M.D.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: February 24, 2021
• Study Start: April 1, 2021
• Primary Completion: December 5, 2022
• Study Completion: March 27, 2023
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)