Contact information
Type
Scientific
Primary contact
Prof Glenys Parry
ORCID ID
Contact details
School of Health and Related Research
Regents Court
30 Regents Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 222 0768
g.d.parry@sheffield.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Clinical and cost-effectiveness of a cognitive behavioural intervention for improved self-management in adults with psychological complications of asthma
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Asthma
Intervention
Patients are randomised to:
1. Cognitive behavioural therapy
2. Care as usual
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1997
Overall trial end date
01/03/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Asthma patients with psychological complications
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/09/1997
Recruitment end date
01/03/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Health and Related Research
Sheffield
S1 4DA
United Kingdom
Sponsor information
Organisation
Record Provided by the NHS R&D 'Time-Limited' National Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Asthma National Research and Development Programme (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary