Condition category
Respiratory
Date applied
03/04/2017
Date assigned
05/04/2017
Last edited
12/07/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Public

Primary contact

Dr Ben Ainsworth

ORCID ID

http://orcid.org/0000-0002-5098-1092

Contact details

University of Southampton
Primary Care & Population Sciences (Faculty of Medicine)
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8024 1085
rpni@soton.ac.uk

Type

Public

Additional contact

Mrs Megan Liddiard

ORCID ID

Contact details

University of Southampton
Primary Care & Population Sciences (Faculty of Medicine)
Aldermoor Health centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
+44 (0)23 8059 1950
rpni@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

34048

Study information

Scientific title

Investigating the feasibility of a mobile mindfulness-based digital intervention for patients with asthma

Acronym

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

South Central- Hampshire B Research Ethics Committee, 17/03/2017, ref: 17/SC/0088

Study design

Randomised; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2017

Overall trial end date

31/03/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 120; UK Sample Size: 120

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

United Kingdom

Trial participating centre

University of Southampton
Primary Care & Population Sciences (Faculty of Medicine) Aldermoor Health Centre Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton

Sponsor details

Room 4055
Building 37
Highfield Campus
Southampton
SO17 1BJ
United Kingdom
+44 (0)23 8059 5058
rginfo@soton.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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)

Intention to publish date

31/03/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

12/07/2017: Internal edit.