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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleClinical and cost-effectiveness of a cognitive behavioural intervention for improved self-management in adults with psychological complications of asthma
Study objectivesResearch 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) studiedAsthma
InterventionPatients are randomised to:
1. Cognitive behavioural therapy
2. Care as usual
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1997
Completion date01/03/2001

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaAsthma patients with psychological complications
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/1997
Date of final enrolment01/03/2001

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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

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