A Trial Platform of Enhanced care for Depression in Primary Care

ISRCTN	ISRCTN63222059
DOI	https://doi.org/10.1186/ISRCTN63222059
Protocol serial number	G0300677
Sponsor	University of York (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof David Richards
Scientific

Dept Health Sciences
Seebohm Rowntree Building
University of York
University Road
Heslington
York
YO10 5DD
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Mental and Behavioural Disorders
Intervention	1. Enhanced care for depression 2. Usual care
Intervention type	Other
Primary outcome measure(s)	Clinical response (change from baseline Hamilton depression HAM-D score), 50% reduction in depressive symptoms
Key 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)
Completion date	30/03/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	144
Key inclusion criteria	Depression presenting in Primary Care
Key exclusion criteria	Depression not as primary diagnosis; suicidal intent
Date of first enrolment	01/07/2004
Date of final enrolment	30/03/2006

Dept Health Sciences

York
YO10 5DD
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2006		Yes	No
Results article	results	01/07/2009		Yes	No