|
ISRCTN
|
ISRCTN63222059
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A Trial Platform of Enhanced care for Depression in Primary Care
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
G0300677
|
|
Study hypothesis
|
1. To design and refine a standardised ECD intervention protocol appropriate to the UK primary health care setting and acceptable to clinicians, practitioners and patients
2. To estimate contamination, clustering and effect size of the intervention within a pilot Phase II trial
3. To estimate trial recruitment rates through monitoring recruitment rates within the pilot Phase II trial
4. To examine the issue of treatment integrity and acceptability by monitoring the implementation of the ECD intervention protocol within a pilot Phase II trial and conducting qualitative stakeholder interviews
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Mental and Behavioural Disorders
|
|
Participants - inclusion criteria
|
Depression presenting in Primary Care
|
|
Participants - exclusion criteria
|
Depression not as primary diagnosis; suicidal intent
|
|
Anticipated start date
|
01/07/2004
|
|
Anticipated end date
|
30/03/2006
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
144
|
|
Interventions
|
1. Enhanced care for depression
2. Usual care
|
|
Primary outcome measure(s)
|
Clinical response (change from baseline Hamilton depression HAM-D score), 50% reduction in depressive symptoms
|
|
Secondary outcome measure(s)
|
1. Quality of life (SF-12 & EQ-5D)
2. Health care utilisation (including GP visits, medication use, secondary care referrals)
3. Prescribing and adherence to medication measured against NICE guidelines (from individual patient records, filled prescriptions and patient self report)
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
|
|
Publications
|
Results: http://www.ncbi.nlm.nih.gov/pubmed/16814628
|
|
Contact name
|
Prof
David
Richards
|
|
Address
|
Dept Health Sciences
Seebohm Rowntree Building
University of York
University Road
Heslington
|
|
City/town
|
York
|
|
Zip/Postcode
|
YO10 5DD
|
|
Country
|
United Kingdom
|
|
Sponsor
|
University of York (UK)
|
|
Address
|
Prof Trevor Sheldon
Department of Health Sciences
Seebohhm Rowntree Building
University of York
University Road
Heslington
|
|
City/town
|
York
|
|
Zip/Postcode
|
YO10 5DD
|
|
Country
|
United Kingdom
|
|
Sponsor website:
|
http://www.york.ac.uk/
|
|
Date applied
|
17/05/2004
|
|
Last edited
|
15/04/2008
|
|
Date ISRCTN assigned
|
14/07/2004
|
