Contact information
Type
Scientific
Primary contact
Prof Peter Tyrer
ORCID ID
Contact details
Departtment of Psychological Medicine
St Dunstan's Road
London
W6 8RP
United Kingdom
+44 (0)20 7386 1237
p.tyrer@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NNHA/600
Study information
Scientific title
Acronym
CBTHA
Study hypothesis
Comprison of the effectiveness of cognitive behaviour therapy focused on health anxiety in a GenitoUrinary Medicine (GUM) clinic compared with treatment as usual.
Ethics approval
Approval received from the North Nottinghamshire Local Research Ethics Committee on the 15th May 2002 (ref no: NNHA/600).
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
Health anxiety (hypochondriasis)
Intervention
Active Treatment Group:
Up to seven sessions of individual cognitive behaviour therapy together with a booklet describing cognitive behaviour therapy in health anxiety (14 pages)
Control Group:
Single interview within the clinic explaining the concept of health anxiety (control group)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Reduction in Health Anxiety Inventory scores (HAI) at six months
Secondary outcome measures
1. HAI at 12 months
2. Changes in social function, anxiety and depression scores at three, six and 12 months
Overall trial start date
01/05/2002
Overall trial end date
30/11/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Outpatients presenting to the GUM clinic at Kings Mill Hospital, Sutton-in-Ashfield, Nottinghamshire and felt to be suffering from health anxiety by any doctor in the clinic (including HS) were given the Health Anxiety Inventory (HAI) and those with a score of 18 or over invited to take part in the study if they were resident in the area, had sufficient command of English to understand the questionnaires and gave written informed consent for research assessment and examination of patient records.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
50
Participant exclusion criteria
Psychotropic drug treatment taken in the previous six months before entry to the study and current psychiatric care.
Recruitment start date
01/05/2002
Recruitment end date
30/11/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Departtment of Psychological Medicine
London
W6 8RP
United Kingdom
Sponsor information
Organisation
Imperial College (UK)
Sponsor details
Exhibition Road
London
SW7 2AZ
United Kingdom
+44 (0)20 7589 5111
j.buckingham@imperial.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Sir Jules Thorn Charitable Trust (UK) (Seedcorn Grant: PC2317)
Alternative name(s)
The Sir Jules Thorn Charitable Trust
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
Sherwood Forest NHS Trust (UK) (ref: P00629)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18827299
Publication citations
-
Results
Seivewright H, Green J, Salkovskis P, Barrett B, Nur U, Tyrer P, Cognitive-behavioural therapy for health anxiety in a genitourinary medicine clinic: randomised controlled trial., Br J Psychiatry, 2008, 193, 4, 332-337, doi: 10.1192/bjp.bp.108.052936.