NCT04769505

Mindfulness-based Interventions in COPD Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Karl Landsteiner Institute for Lung Research and Pneumological Oncology · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease Exacerbation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-12-05
• Completion: 2023-03-27
• First posted: 2021-02-24
• Last updated: 2024-03-18

Locations

1 site across 1 country: Austria