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Open Access Highly Accessed Study protocol

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

A Niroshan Siriwardena12*, Tanefa Apekey2, Michelle Tilling2, Andrew Harrison3, Jane V Dyas4, Hugh C Middleton5, Roderick Ørner6, Tracey Sach7, Michael Dewey8 and Zubair M Qureshi2

Author Affiliations

1 Faculty of Health, Life & Social Sciences, University of Lincoln Brayford Pool, Lincoln, LN6 7TS, UK

2 NHS Lincolnshire, Cross O'Cliff Court, Bracebridge Heath, Lincolnshire, LN4 2HN, UK

3 Linking Voices, Church Lane, Sleaford, Lincolnshire, NG34 7DF, UK

4 National Institute for Health Research, Research Design Service East Midlands, Tower Building, University Park, Nottingham, NG7 2RD, UK

5 School of Sociology and Social Policy, University of Nottingham, University Park, Nottingham, NG7 2RD, UK

6 Somerby Clinic, 8 Lindum Terrace, Lincoln, LN2 5RS, UK

7 School of Chemical Sciences and Pharmacy, Health Economics Group, University of East Anglia, Norwich, NR4 7TJ, UK

8 Health Service and Population Research, Institute of Psychiatry, Box P060, De Crespigny Park, London, SE5 8AF, UK

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BMC Family Practice 2009, 10:9  doi:10.1186/1471-2296-10-9

Published: 26 January 2009

Abstract

Background

Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety.

Methods and design

This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing.

Discussion

Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation.

Trial Registration

ClinicalTrials.gov ID ISRCTN55001433 – http://www.controlled-trials.com/ISRCTN55001433 webcite