Condition category
Respiratory
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Not specified

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes