Abstract
BackgroundAround 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/DesignThis 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.DiscussionThe 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 registrationCurrent Controlled Trials (ISRCTN54036115)
Highlights
Around 150,000 people each year attend hospitals in England due to self-harm, many of them more than once
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
Participants Inclusion criteria To be included in the study, participants must meet the following eligibility criteria: a) be aged 18 years or over; b) have attended the emergency department or been admitted to a general hospital as a consequence of self-harm within the last six weeks; c) not already be participating in the MIDSHIPS trial; and d) where the presenting episode is due to alcohol or recreational drugs, the participant explicitly stated that they were intending self-harm by use of alcohol or recreational drugs
Summary
Therapy is not routinely offered to people attending hospital due to self-harm as there is no form of therapy that has been proven to be effective [14,16]. We expect that the present study will provide, at reasonable financial and ethical cost, valuable information needed for the planning of the most important aspects of a definitive trial – concerning the therapy manual, recruitment and training of therapists, recruitment and retention of participants, delivery of therapy, adherence to the therapy manual, and the collection of baseline and follow up data. AF is a co-holder of the grant, is the statistical guarantor, contributed to the design of the study, protocol development and writing of this manuscript. LG, SH, AH, LP, DP, are co-holders of the grant and contributed to the design of the study, protocol development and writing of this manuscript. KB contributed to the design of the study, protocol development, collection of data and writing of this manuscript. ST is an associate professor in health economics and has expertise in the design and delivery of economic evaluations
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