Writing about emotional experiences to reduce symptoms, improve quality of life and improve lung function in patients with asthma: a randomised controlled trial
| ISRCTN | ISRCTN82986307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82986307 |
| Secondary identifying numbers | N0051127195 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 06/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Addressing the psychological needs of patients can produce improvements in both their mental and physical health. In the last decade several research studies have demonstrated that writing about emotionally traumatic experiences can improve how well people feel and reduce their use of health care services. More recently studies have begun to focus on people with particular chronic diseases and a study from North America suggested that in patients with asthma, expressive writing improved lung function by 12% for up to 4 months after the writing has stopped. In this study we will test whether writing about stressful experiences can improve lung function, decrease symptoms and improve quality of life in people with asthma in Britain. If improvements are observed, we will continue to follow study participants to determine for how long these improvements are sustained.
Who can participate?
Adult patients aged 18-45 with asthma.
What does the study involve?
We will allocate participants to one of two groups, to either write about stressful experiences or to write about time management. Participants in both groups will be asked to write for 20 minutes on 3 consecutive days in their own homes. We will assess participants’ lung function, symptoms, quality of life and medication used at the start of the study, and after 1, 3, 6 and 12 months.
What are the possible benefits and risks of participating?
A great deal of research has shown a beneficial effect on physical health, social and emotional well-being following writing about stressful events. Specifically, asthma patients have shown an improvement in lung function after writing. Therefore we think that at least some of participants in the stressful writing group will benefit in terms of lung function, reduced symptoms and quality of life. Previous studies indicate that rarely, emotional disclosure can lead to short-lived distress, but in over 20 years of research of this kind it is very rare that any participant has become seriously distressed.
Where is the study run from?
Brighton & Sussex Medical School (UK).
When is the study starting and how long is it expected to run for?
From May 2003 to June 2008.
Who is funding the study?
Brighton and Sussex University Hospitals NHS Trust, Asthma Research UK and Asthma UK.
Who is the main contact?
Prof Helen Smith (H.E.Smith@bsms.ac.uk)
Ms Alice Theadom (a.theadom@bsms.ac.uk)
Contact information
Scientific
Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom
| H.E.Smith@bsms.ac.uk |
Public
Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom
| a.theadom@bsms.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Writing about emotional experiences to reduce symptoms, improve quality of life and improve lung function in patients with asthma: a randomised controlled trial |
| Study objectives | 1. Can writing about stressful experiences decrease symptoms, improve quality of life and improve lung function in patients with asthma? 2. For how long are these improvements sustained? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Asthma |
| Intervention | A pragmatic, randomised controlled trial of expressive writing for patients with asthma versus no writing. |
| Intervention type | Other |
| Primary outcome measure | Lung function (forced expiratory volume in one second [FEV1], peak expiratory flow [PEF]) (primary outcome). Symptom scores, quality of life, medication use and health service use will be used as secondary outcome measures. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2003 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | We aim to recruit 144 participants into the main study |
| Key inclusion criteria | Adult patients (18-45) registered with participating general practices with a diagnosis of asthma and requiring regular inhaled medication (British Thoracic Society [BTS] steps 2-4). The upper age limit has been chosen to exclude people whose respiratory problems may be due to chronic obstructive pulmonary disease (COPD). |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BN1 9PH
United Kingdom
Sponsor information
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Charity
No information available
No information available
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Asthma UK, Asthma + Lung UK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The trial is completed and the manuscript has been accepted for publication. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2015 | Yes | No |
