Clinical and cost-effectiveness of a cognitive behavioural intervention for improved self-management in adults with psychological complications of asthma

ISRCTN	ISRCTN45927583
DOI	https://doi.org/10.1186/ISRCTN45927583
Secondary identifying numbers	N/A

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 02/06/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Glenys Parry
Scientific

School of Health and Related Research
Regents Court
30 Regents Street
Sheffield
S1 4DA
United Kingdom

Phone	+44 (0)114 222 0768
Email	g.d.parry@sheffield.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Clinical and cost-effectiveness of a cognitive behavioural intervention for improved self-management in adults with psychological complications of asthma
Study objectives	Research evidence suggests that NHS costs of treatment of asthma in adults are associated with psychosocial factors, including for some patients, dysfunctional health beliefs and high levels of panic-fear. Clinical research and pilot work provides prima facie evidence that a brief cognitive behavioural intervention can significantly reduce levels of panic-fear, and hence service-usage. This project will estimate the proportion of a defined population who would benefit from an effective psychological intervention for improved self management of chronic asthma and compares the outcomes (clinical, psychological, economic and quality of life) for a randomly selected group of patients with psychological complications receiving a brief cognitive behavioural intervention, compared to a control group receiving standard medical treatment. The two phases of the project will yield cost-effectiveness data which can be generalised to give estimates of health gain and costs savings for a given population of known asthma and panic-fear prevalence.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	Patients are randomised to: 1. Cognitive behavioural therapy 2. Care as usual
Intervention type	Other
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/1997
Completion date	01/03/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Asthma patients with psychological complications
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/1997
Date of final enrolment	01/03/2001

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Health and Related Research

Sheffield
S1 4DA
United Kingdom

Sponsor information

Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Asthma National Research and Development Programme (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

02/06/2017: No publications found in PubMed, verifying study status with principal investigator