Condition category
Mental and Behavioural Disorders
Date applied
17/05/2004
Date assigned
14/07/2004
Last edited
02/07/2009
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 David Richards

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0300677

Study information

Scientific title

Acronym

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Not Specified

Patient information sheet

Condition

Mental and Behavioural Disorders

Intervention

1. Enhanced care for depression
2. Usual care

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/07/2004

Overall trial end date

30/03/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Depression presenting in Primary Care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

144

Participant exclusion criteria

Depression not as primary diagnosis; suicidal intent

Recruitment start date

01/07/2004

Recruitment end date

30/03/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept Health Sciences
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

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

Sponsor type

University/education

Website

http://www.york.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16814628
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19011721

Publication citations

  1. Results

    Richards DA, Lankshear AJ, Fletcher J, Rogers A, Barkham M, Bower P, Gask L, Gilbody S, Lovell K, Developing a U.K. protocol for collaborative care: a qualitative study., Gen Hosp Psychiatry, 28, 4, 296-305, doi: 10.1016/j.genhosppsych.2006.03.005.

  2. Results

    Mann R, Gilbody S, Richards D, Putting the 'Q' in depression QALYs: a comparison of utility measurement using EQ-5D and SF-6D health related quality of life measures., Soc Psychiatry Psychiatr Epidemiol, 2009, 44, 7, 569-578, doi: 10.1007/s00127-008-0463-5.

Additional files

Editorial Notes