Condition category
Mental and Behavioural Disorders
Date applied
15/10/2006
Date assigned
06/02/2007
Last edited
03/10/2008
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 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 measures

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

Eligibility

Participant inclusion criteria

Outpatients 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.

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

http://www.imperial.ac.uk

Funders

Funder type

Charity

Funder name

Sir Jules Thorn Charitable Trust (UK) (Seedcorn Grant: PC2317)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18827299

Publication citations

  1. 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.

Additional files

Editorial Notes