A Trial Platform of Enhanced care for Depression in Primary Care

ISRCTN	ISRCTN63222059
DOI	https://doi.org/10.1186/ISRCTN63222059
Secondary identifying numbers	G0300677

Submission date: 17/05/2004
Registration date: 14/07/2004
Last edited: 02/07/2009

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 David Richards
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Not Specified
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	Clinical response (change from baseline Hamilton depression HAM-D score), 50% reduction in depressive symptoms
Secondary outcome measures	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)
Overall study start date	01/07/2004
Completion date	30/03/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Dept Health Sciences

York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

Prof Trevor Sheldon
Department of Health Sciences
Seebohhm Rowntree Building
University of York
University Road
Heslington
York
YO10 5DD
England
United Kingdom

Website	http://www.york.ac.uk/
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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	01/07/2006		Yes	No
Results article	results	01/07/2009		Yes	No