| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN82986307 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0051127195 |
| Public title | Writing about emotional experiences to reduce symptoms, improve quality of life and improve lung function in patients with asthma: a randomised controlled trial |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Respiratory: Asthma |
| Study hypothesis | 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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). |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/05/2003 |
| Anticipated end date | 30/06/2008 |
| Status of trial | Ongoing |
| Target number of participants | We aim to recruit 144 participants into the main study |
| Interventions | A pragmatic, randomised controlled trial of expressive writing for patients with asthma versus no writing.
Contact for public queries:
Alice Theadom
Email: a.theadom@bsms.ac.uk |
| Primary outcome measure(s) | 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 measure(s) | Not provided at time of registration |
| Sources of funding | Pilot phase funded by:
1. Brighton and Sussex University Hospitals NHS Trust (UK)
2. Asthma Research UK (UK)
RCT funded by:
Asthma UK (UK) |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Prof Helen Smith |
| Contact details | Brighton & Sussex Medical School
Falmer
Brighton
United Kingdom
BN1 9PH |
| Contact email | H.E.Smith@bsms.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82986307 |
| Date last extracted from ISRCTN register | 17/04/2008 |
