Open Access Study protocol

A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

André Tylee1*, Mark Haddad1, Elizabeth Barley1, Mark Ashworth2, June Brown3, John Chambers4, Anne Farmer5, Zoe Fortune1, Rebecca Lawton1, Morven Leese1, Anthony Mann1, Paul McCrone1, Joanna Murray1, Carmine Pariante6, Rachel Phillips1, Diana Rose1, Gill Rowlands7, Ramon Sabes-Figuera1, Alison Smith1 and Paul Walters1

Author Affiliations

1 Health Services and Population Research Dept, Institute of Psychiatry at King’s College London, De Crespigny Park, London, SE5 8AF, UK

2 Department of Primary Care and Public Health Sciences, King’s College London, 9th Floor, Capital House, 42 Weston Street, London, SE1 3QD, UK

3 Department of Psychology, Institute of Psychiatry at King’s College London, De Crespigny Park, London, SE5 8AF, UK

4 Department of Cardiology, Guy’s and St Thomas’ Hospitals, Westminster Bridge Road, London, SE17EH, UK

5 Department of Social Genetic and Developmental Psychiatry, Institute of Psychiatry at King’s College London, De Crespigny Park, London, SE5 8AF, UK

6 Department of Psychological Medicine, Institute of Psychiatry at King’s College London, De Crespigny Park, London, SE5 8AF, UK

7 Faculty of Health and Social Care, London South Bank University, 103 Borough Road, London, SE1 0AA, UK

For all author emails, please log on.

BMC Psychiatry 2012, 12:58  doi:10.1186/1471-244X-12-58

Published: 6 June 2012

Abstract

Background

Community studies reveal people with coronary heart disease (CHD) are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings.

Methods

This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP) care.

81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D) together with symptomatic CHD identified using the Modified Rose Angina Questionnaire.

Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their problems.

Depressive symptoms measured by HADS score will be collected at baseline and 1, 6- and 12 months post randomisation. Other outcomes include CHD symptoms, quality of life, wellbeing and health service utilisation.

Discussion

This practical and patient-focused intervention is potentially an effective and accessible approach to the health and social care needs of people with depression and CHD in primary care.

Trial registration

ISRCTN21615909.