Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Helen Smith
ORCID ID
Contact details
Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom
-
H.E.Smith@bsms.ac.uk
Type
Public
Additional contact
Ms Alice Theadom
ORCID ID
Contact details
Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom
-
a.theadom@bsms.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0051127195
Study information
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
Acronym
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?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Respiratory: Asthma
Intervention
A pragmatic, randomised controlled trial of expressive writing for patients with asthma versus no writing.
Intervention type
Other
Phase
Not Specified
Drug names
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 trial start date
01/05/2003
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
We aim to recruit 144 participants into the main study
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/03/2007
Recruitment end date
01/05/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton & Sussex Medical School
Brighton
BN1 9PH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Brighton and Sussex University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Asthma Research UK (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Asthma UK (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The trial is completed and the manuscript has been accepted for publication.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25939030