Condition category
Respiratory
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
06/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

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

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

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25939030

Publication citations

Additional files

Editorial Notes