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Open Access Study protocol

MIDSHIPS: Multicentre Intervention Designed for Self-Harm using Interpersonal Problem-Solving: protocol for a randomised controlled feasibility study

Michelle Collinson1*, David Owens2*, Paul Blenkiron3, Kayleigh Burton1, Liz Graham1, Simon Hatcher4, Allan House2, Katie Martin3, Louise Pembroke2, David Protheroe3, Sandy Tubeuf2 and Amanda Farrin1

Author Affiliations

1 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK

2 Leeds Institute of Health Sciences, University of Leeds, Leeds LS2 9JT, UK

3 Leeds and York Partnership NHS Foundation Trust, 2150 Century Way, Thorpe Park, Leeds LS15 8ZB, UK

4 Department of Psychiatry, University of Ottawa, 5457-1145 Carling Avenue, Ottawa, Ontario K1Z 7 K4, Canada

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Trials 2014, 15:163  doi:10.1186/1745-6215-15-163

Published: 10 May 2014

Abstract

Background

Around 150,000 people each year attend hospitals in England due to self-harm, many of them more than once. Over 5,000 people die by suicide each year in the UK, a quarter of them having attended hospital in the previous year because of self-harm. Self-harm is a major identifiable risk factor for suicide. People receive variable care at hospital; many are not assessed for their psychological needs and little psychological therapy is offered. Despite its frequent occurrence, we have no clear research evidence about how to reduce the repetition of self-harm. Some people who have self-harmed show less active ways of solving problems, and brief problem-solving therapies are considered the most promising psychological treatments.

Methods/Design

This is a pragmatic, individually randomised, controlled, feasibility study comparing interpersonal problem-solving therapy plus treatment-as-usual with treatment-as-usual alone, for adults attending a general hospital following self-harm. A total of 60 participants will be randomised equally between the treatment arms, which will be balanced with respect to the type of most recent self-harm event, number of previous self-harm events, gender and age. Feasibility objectives are as follows: a) To establish and field test procedures for implementing the problem-solving intervention; b) To determine the feasibility and best method of participant recruitment and follow up; c) To assess therapeutic delivery; d) To assess the feasibility of obtaining the definitive trial’s primary and secondary outcomes; e) To assess the perceived burden and acceptability of obtaining the trial’s self-reported outcome data; f) To inform the sample size calculation for the definitive trial.

Discussion

The results of this feasibility study will be used to determine the appropriateness of proceeding to a definitive trial and will allow us to design an achievable trial of interpersonal problem-solving therapy for adults who self-harm.

Trial registration

Current Controlled Trials (ISRCTN54036115)

Keywords:
Self-harm; Problem-solving therapy; Suicide; Self-poisoning; Self-injury