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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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

Prof Helen Smith
Scientific

Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom

Email H.E.Smith@bsms.ac.uk
Ms Alice Theadom
Public

Brighton & Sussex Medical School
Falmer
Brighton
BN1 9PH
United Kingdom

Email a.theadom@bsms.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleWriting about emotional experiences to reduce symptoms, improve quality of life and improve lung function in patients with asthma: a randomised controlled trial
Study objectives1. 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) studiedRespiratory: Asthma
InterventionA pragmatic, randomised controlled trial of expressive writing for patients with asthma versus no writing.
Intervention typeOther
Primary outcome measureLung 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 measuresNot provided at time of registration
Overall study start date01/05/2003
Completion date30/06/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit45 Years
SexBoth
Target number of participantsWe aim to recruit 144 participants into the main study
Key inclusion criteriaAdult 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 criteriaNot provided at time of registration
Date of first enrolment01/03/2007
Date of final enrolment01/05/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Brighton & Sussex Medical School
Brighton
BN1 9PH
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Charity

Brighton and Sussex University Hospitals NHS Trust (UK)

No information available

Asthma Research UK (UK)

No information available

Asthma UK (UK)
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 shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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