Mindfulness for patients with difficult-to-manage asthma
| ISRCTN | ISRCTN24452721 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24452721 |
| Protocol serial number | 20243 |
| Sponsor | University of Southampton |
| Funder | National Institute for Health Research |
- Submission date
- 13/01/2016
- Registration date
- 13/01/2016
- Last edited
- 19/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Asthma is a long-term condition which affects the airways. It can affect people of any age, however in usually is first spotted during childhood. When a person is suffering from asthma, the bronchi (tubes which carry air in and out of the lungs) can become narrowed or swollen (inflammation). This can cause a range of distressing symptoms such as wheezing, chest tightness and breathlessness. During episodes of breathlessness, many patients with asthma experience anxiety which puts their lungs under even more stress. It has been found that patients with severe and poorly controlled asthma (PCA) often experience more symptoms when compared to those with better controlled disease. It is likely that this is associated with higher levels of anxiety, which can make it very difficult to cope day-to-day. Mindfulness is a concept designed to help people to become more aware of their thoughts and feelings in order to become more self-aware and accepting of the current moment. Its use in the treatment of people suffering from mental health problems is steadily increasing, and new programs are being developed to help people with different medical problems. The aim of this study is to find out whether a short course of mindfulness-based training is an effective way of helping patients who are struggling to control their asthma to cope better.
Who can participate?
Adults who have asthma and attend the “Difficult Asthma Clinic” at Southampton General Hospital.
What does the study involve?
All participants attend four sessions of mindfulness-based training. The training is given in group sessions, once a week, lasting for around one hour. “Daily homework”, such as meditation exercises, is also given to participants to practice at home every day. Participants are also interviewed and complete a number of questionnaires in order to evaluate whether the mindfulness training is an effective treatment for patients suffering from poorly controlled asthma.
What are the possible benefits and risks of participating?
Participants may benefit from getting new ideas which could help them to better manage their asthma. There are no significant risks of taking part, however participating does involve a time commitment.
Where is the study run from?
Southampton General Hospital (UK)
When is the study starting and how long is it expected to run for?
December 2015 to December 2016
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mrs Megan Liddiard
Contact information
Public
University of Southampton
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Investigating the impact of a short-course MBSR-based mindfulness intervention on patients with difficult-to-manage asthma |
| Study objectives | The aim of this study is to develop a short mindfulness meditation intervention for patients from the Southampton General Hospital ‘difficult asthma’ clinics, and to establish whether it can be successfully delivered (and is acceptable) to patients with poorly controlled asthma (PCA). |
| Ethics approval(s) | South Central - Berkshire B Research Ethics Committee, 12/10/2015, ref: 15/SC/0522 |
| Health condition(s) or problem(s) studied | Topic: Primary Care, Respiratory disorders; Subtopic: Respiratory (all Subtopics), Respiratory disorders; Disease: Respiratory, All Diseases |
| Intervention | At baseline, participants provide informed consent and complete a battery of self-report questionnaires and computerized measures and routinely-collected clinic data will be collected during routine patient clinic sessions in the UHS Difficult Asthma Clinic. All participants then take part in a short mindfulness-based meditation course, involving 4 weekly 1.5 hour sessions with daily homework practice. The sessions will build experience progressing through attention training practices, to reconnecting the mind and body developing awareness of bodily signatures of stress, anxiety and low mood and learning practical techniques of how to deal with them. Session 1 explores the common stories and emotions that we get caught up with when our mind is wandering and causes distress. In this session participants learn how to calm a wandering mind with attention training using the breath as a focus, Session 2 reconnects the mind and body, providing a suitable mindfulness tool for these patients. In the 3rd session components of MBCT will be introduced exploring “thoughts are not facts” and how to deal with difficulties. The final session looks at how to establish and sustain a mindfulness practice and explores how to integrate mindfulness into daily life. Mindful movement such as gentle stretching and mindful walking is introduced. At the end of this course participants will have a tool box of mindfulness techniques to draw on and support them. Participants are requested to do home practice for at least 6 days of the week for 10-20minutes a day if possible using recordings to pace and guide them. They will be requested to keep a homework diary to log their practice and experience, as well as facilitating engagement. The three formal mindfulness techniques of body scan, focusing on the breath and gentle stretching exercises are taught. Although a set curriculum is outlined for the intervention, as with all mindfulness programmes due to their experiential nature and variation in groups there is some flexibility. After 3 months, participants will complete a second battery of self-report questionnaires, computerized measures and clinic data in the UHS Difficult Asthma Clinic Focus groups will be conducted 6 weeks after the intervention to elicit in depth discussion on the experiences of taking part and the acceptability of the intervention. Throughout the study, the recruitment procedures, recruitment rates/uptake, adherence and attrition are monitored using descriptive statistics. A thematic analysis of focus group data will be conducted to ensure an inductive approach. |
| Intervention type | Other |
| Primary outcome measure(s) |
Asthma-related quality of life is measured using the Asthma Quality of Life Questionnaire (AQLQ) at baseline and 3 months post-test. |
| Key secondary outcome measure(s) |
1. Asthma control is measured using The Asthma Control Test (ACT) at baseline and 3 months post-test |
| Completion date | 31/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Aged 18 years or over 2. Confirmed diagnosis of Asthma 3. Under the care of the Difficult Asthma Clinic at Southampton General Hospital (University Hospital Southampton NHS Foundation Trust) 4. Positive screening score for anxiety (greater than 8 on the HADS hospital anxiety and depression scale) |
| Key exclusion criteria | 1. Under 18 years of age 2. Comorbid psychological disorders other than anxiety/depression measured using MINI Neuropsychiatric Interview questionaire 3. Acute exacerbation of asthma needing course of oral steroid or increased dose of maintenance steroid within 28 days of first intervention session 4. Current participation in an additional asthma intervention study |
| Date of first enrolment | 13/01/2015 |
| Date of final enrolment | 29/02/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Tremona Road
Southampton
SO16 6YD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and analysed during the current study will be available upon request from M.E.Liddiard@soton.ac.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 12/05/2017 | 16/05/2017 | No | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN24452721_BasicResults_12May17.docx
- Uploaded 16/05/2017
Editorial Notes
16/05/2017: The results summary has been uploaded and the IPD sharing statement added.
11/05/2017: The overall trial end date has been updated from 31/05/2016 to 31/12/2016.
