Mobile mindfulness for asthma
| ISRCTN | ISRCTN52212323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52212323 |
| Secondary identifying numbers | 34048 |
- Submission date
- 03/04/2017
- Registration date
- 05/04/2017
- Last edited
- 11/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Mindfulness is a type of meditation-based therapy that's been used to treat a range of health conditions, including anxiety and depression. Currently, few studies have explored how mindfulness can help long-term health conditions such as asthma. A previous study looked at how acceptable a traditional ‘short-course’ of mindfulness was to help patients with asthma. The patients in this study liked mindfulness and felt it helped how they felt about their asthma, but attendance was low, perhaps because of the commitment of attending a weekly group meeting. The researchers want to see if ‘Headspace’, a mindfulness-based ‘online’ programme (app and website), can help. The Headspace programme takes 30 days of 10-minute practices that can be done whenever it’s convenient for the user. This feasibility study will mainly look at how many people want to take part in the study, how many go on to take part and how many complete the process, but will also look at how much mindfulness could help improve quality of life for people with asthma. The aim of this study is to look at whether using Headspace to people with asthma is feasible and effective at improving quality of life.
Who can participate?
Adults who have asthma and access to the internet.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given the opportunity to start using the Headspace app straight away to use for six months. Those in the second group continue as normal and are given the opportunity to try Headspace after the study ends. At the start of the study and then six week and three months later, participants in both groups complete a range of questionnaires to assess their wellbeing. In addition, the number of participants who took part and those who completed all assessments is recorded to see if a larger study would be possible.
What are the possible benefits and risks of participating?
It is possible that taking part in the study may benefit people in a number of different ways, mostly by improving how their breathing affects them and their quality of life. There is very little risk of harm in taking part, and previous studies have found no negative events. Some people have found that mindfulness can make them anxious, especially if they have been diagnosed with mental health problems but if participants have any questions they can contact the study team.
Where is the study run from?
University of Southampton (UK)
When is the study starting and how long is it expected to run for?
April 2017 to March 2018
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
1. Dr Ben Ainsworth (scientific)
rpni@soton.ac.uk
2. Mrs Megan Liddiard (public)
rpni@soton.ac.uk
Contact information
Public
University of Southampton
Primary Care & Population Sciences (Faculty of Medicine)
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
 ORCID ID |
0000-0002-5098-1092 |
|---|---|
| Phone | +44 (0)23 8024 1085 |
| rpni@soton.ac.uk |
Scientific
Department of Psychology
University of Bath
Claverton Down
Bath
BA2 7AY
United Kingdom
| ORCID ID |
0000-0002-5098-1092 |
|---|---|
| Phone | +44 (0) 1225 383114 |
| B.Ainsworth@bath.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Investigating the feasibility of a mobile mindfulness-based digital intervention for patients with asthma |
| Study hypothesis | The aim of this study is to determine the feasibility and estimate effectiveness of Headspace, a digital mindfulness-based stress reduction app, in helping to improve quality of life for people with asthma. |
| Ethics approval(s) | South Central- Hampshire B Research Ethics Committee, 17/03/2017, ref: 17/SC/0088 |
| Condition | Specialty: Primary Care, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Respiratory/ Chronic lower respiratory diseases |
| Intervention | All participants in the study will complete questionnaire measures about their asthma, quality of life and mindfulness. These will primarily be delivered online at baseline, 6 weeks (post baseline) and at 3 months. Following consent, participants will randomly allocated to one of two groups. Randomisation will be electronically via the Life Guide web platform. Intervention Group: This group will have the opportunity to use the Headspace app and website immediately for 6 months. Control group: This group will continue as normal for the duration of the study and will have the opportunity to use the Headspace app and website 3 months after they have completed all of the questionnaires for the study. All participants will be in the study for 3 months in total. All participants will be given access to the Headspace App at no cost during the study. Should they wish, participants in both groups will be able to request an additional 6 months of free access to Headspace at the end of the study. A purposive sample of participants will also be invited to take part in a telephone interview at 6 weeks post intervention to elicit in depth discussions on the experiences of taking part and the acceptability of the intervention. |
| Intervention type | Other |
| Primary outcome measure | Feasibility outcomes: 1. Response rate is recorded as the number of participants who respond favourably to the Patient Invite Letter by 6 months 2. Recruitment rate is recorded as the number of eligible participants who consent to participate in the study by 6-9 months 3. Retention rate is recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 3 months |
| Secondary outcome measures | 1. Headspace usage will measured by data access granted by Headspace to allow the study team to monitor intervention usage- and whether this is associated with symptom improvement which will be measured by using validated quality of life questionnaires, primarily the Asthma Quality of Life Questionnaire (AQLQ) at baseline, 6 weeks and 3 months 2. Participant experience of taking part in the study and the acceptability of the intervention will be measured by qualitative analysis of telephone interviews on a purposive sample of participants from the intervention group up to 6 weeks post- intervention 3. Anxiety and asthma- specific quality of life will be measured using validated questionnaire measures at baseline, 6 weeks and 3 months with the primary questionnaire outcome measure being the Asthma Quality of Life Questionnaire (AQLQ) 4. Self- reported mindfulness will be measured using validated questionnaire measures below at baseline, 6 weeks and 3 months 5. Asthma-related quality of life is measured by the Asthma Quality of Life Questionnaire (AQLQ) at baseline, 6 weeks and 3 months 6. Asthma control is measured by the Asthma Control Questionnaire (ACQ) at baseline, 6 weeks and 3 months 7. Anxiety and depression is measured by the Hospital Anxiety and Depression Scale (HADS) at baseline, 6 weeks and 3 months 8. Enablement is measured by the Patient Enablement Instrument (PEI) at baseline, 6 weeks and 3 months 9. Mindfulness is measured by the Philadelphia Mindfulness Scale (PMS) at baseline, 6 weeks and 3 months 10. Medication adherence is measured by the Medication Adherence Report Scale for Asthma (MARS-A) at baseline, 6 weeks and 3 months 11. Acceptance and action is measured by the Acceptance and action questionnaire (AAQ-II) at baseline, 6 weeks and 3 months |
| Overall study start date | 01/04/2017 |
| Overall study end date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 120; UK Sample Size: 120 |
| Total final enrolment | 158 |
| Participant inclusion criteria | 1. Adult (18 years or over) 2. Have a confirmed diagnosis of asthma- between steps 2 and 4 of BTS Asthma Guidelines for symptom severity (mild to moderate) 3. Have access to the Internet- which can be either a computer or a mobile device |
| Participant exclusion criteria | 1. Under 18 years of age 2. Previously diagnosed major and unstable comorbid psychological disorders other than anxiety / depression (measured using the MINI neuropsychiatric interview questionnaire) 3. Current participation in another asthma intervention study 4. Have had acute exacerbation of asthma (needing a course of oral steroid or increased dose of maintenance steroid) within 28 days of the first intervention of the study |
| Recruitment start date | 01/06/2017 |
| Recruitment end date | 31/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Sponsor information
University/education
Room 4055, Building 37
Highfield Campus
Southampton
SO17 1BJ
England
United Kingdom
| Phone | +44 (0)23 8059 5058 |
|---|---|
| rginfo@soton.ac.uk | |
"ROR" |
https://ror.org/01ryk1543 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Plans to present and disseminate study results at conferences (such as the Society for Academic Primary Care ( SW SAPC) 2018 & European Respiratory Society International Congress 2018) 2. Planned publication in a high-impact peer reviewed journal potentially in 2019 (for example, the European Respiratory Journal) |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Ben Ainsworth (ben.ainsworth@southampton.ac.uk) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | results presented at the European Resopiratory Society (ERS) International Congress | 09/11/2018 | 26/03/2019 | No | No |
| Results article | 27/08/2021 | 31/08/2021 | Yes | No | |
| Protocol file | version 1.5 | 05/06/2017 | 11/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
11/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
31/08/2021: Publication reference added.
27/03/2019: Ben Ainsworth has replaced Megan Liddiard as the scientific contact.
26/03/2019: The following changes have been made:
1. The overall trial end date has been changed from 31/03/2018 to 31/05/2018.
2. The intention to publish date has been changed from 31/03/2019 to 01/05/2019.
3. The total final enrolment number has been added.
4. Publication reference added.
12/07/2017: Internal edit.
