Cognitive Behaviour Therapy for Health Anxiety in a genitourinary medicine clinic

ISRCTN ISRCTN51344336
DOI https://doi.org/10.1186/ISRCTN51344336
Protocol serial number NNHA/600
Sponsor Imperial College (UK)
Funders Sir Jules Thorn Charitable Trust (UK) (Seedcorn Grant: PC2317), Sherwood Forest NHS Trust (UK) (ref: P00629)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymCBTHA
Study objectivesComprison 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) studiedHealth anxiety (hypochondriasis)
InterventionActive 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 typeOther
Primary outcome measure(s)

Reduction in Health Anxiety Inventory scores (HAI) at six months

Key secondary outcome measure(s)

1. HAI at 12 months
2. Changes in social function, anxiety and depression scores at three, six and 12 months

Completion date30/11/2006

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration50
Key inclusion criteriaOutpatients presenting to the GUM clinic at King’s 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 criteriaPsychotropic drug treatment taken in the previous six months before entry to the study and current psychiatric care.
Date of first enrolment01/05/2002
Date of final enrolment30/11/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Departtment of Psychological Medicine
London
W6 8RP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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