Cognitive Behaviour Therapy for Health Anxiety in a genitourinary medicine clinic

ISRCTN	ISRCTN51344336
DOI	https://doi.org/10.1186/ISRCTN51344336
Secondary identifying numbers	NNHA/600

Submission date: 15/10/2006
Registration date: 06/02/2007
Last edited: 03/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peter Tyrer
Scientific

Departtment of Psychological Medicine
St Dunstan's Road
London
W6 8RP
United Kingdom

Phone	+44 (0)20 7386 1237
Email	p.tyrer@imperial.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	CBTHA
Study objectives	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(s)	Approval received from the North Nottinghamshire Local Research Ethics Committee on the 15th May 2002 (ref no: NNHA/600).
Health condition(s) or problem(s) studied	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
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 study start date	01/05/2002
Completion date	30/11/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	50
Key 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.
Key exclusion criteria	Psychotropic drug treatment taken in the previous six months before entry to the study and current psychiatric care.
Date of first enrolment	01/05/2002
Date of final enrolment	30/11/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Departtment of Psychological Medicine

London
W6 8RP
United Kingdom

Sponsor information

Imperial College (UK)
University/education

Exhibition Road
London
SW7 2AZ
England
United Kingdom

Phone	+44 (0)20 7589 5111
Email	j.buckingham@imperial.ac.uk
Website	http://www.imperial.ac.uk
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Charity

Sir Jules Thorn Charitable Trust (UK) (Seedcorn Grant: PC2317)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): The Sir Jules Thorn Charitable Trust
Location: United Kingdom

Sherwood Forest NHS Trust (UK) (ref: P00629)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/10/2008		Yes	No