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ISRCTN
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ISRCTN65171515
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ClinicalTrials.gov identifier
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Public title
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Contact and information after self-harm pilot study
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Scientific title
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A pilot study of a contact and information based intervention to reduce repeat self-harm
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Acronym
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N/A
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Serial number at source
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8434
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Study hypothesis
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The study is funded by the National Institute of Health Research and will be carried out on patients who have recently attended the emergency departments at two hospitals in Manchester following an episode of self-harm.
We plan to recruit between 50 - 100 people over a three month period who have been discharged from the emergency department following self-harm, into the intervention group or the control group. The intervention group will receive an information leaflet providing details of local and national support agencies, followed by two phone calls, and then letters intermittently up to 12 months after recruitment. Both groups will receive their treatment as usual. The rationale for the intervention is to provide contact and facilitate patient access to appropriate treatment. The phone calls and letters will be from a mental health clinician. The main aim of this study is to inform the implementation of a large multicentre randomised control study. We will also investigate whether the intervention reduces repetition of self-harm.
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Lay summary
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Ethics approval
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North West 9 Research Ethics Committee - Greater Manchester West approved on the 24th May 2010 (ref: 10/H1014/35)
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Study design
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Single centre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Mental Health Research Network; Subtopic: Suicide and self-harm; Disease: Suicide and self harm
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Participants - inclusion criteria
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1. Adults aged over 18 years, either sex
2. Present to the study hospitals with self-harm
Recruitment may take up to three months or we may achieve our target sample size at an earlier stage. "Self-harm" is defined as "an act of intentional self-injury or poisoning irrespective of the apparent purpose of the act". This includes attempts regardless of suicidal intent or medical seriousness and as a definition is in line with that used by NICE guidelines on the short term management of self-harm.
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Participants - exclusion criteria
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1. Psychiatric in-patients
2. No fixed abode
3. Do not have telephone access
4. Unable to give informed consent during the first telephone call
5. Have been approached at an earlier stage in the study and had refused consent
6. Not able to understand the English language
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Anticipated start date
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01/04/2010
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Anticipated end date
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30/09/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 100; UK sample size: 100
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Interventions
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Patients in the intervention group will receive two phone calls from a clinical researcher soon after hospital attendance, an information leaflet listing local sources of help, and then letters intermittently up to 12 months after recruitment, as well as treatment as usual.
Patients in the control group will receive treatment as usual.
Follow-up length: 12 months
Study entry: single randomisation only
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Primary outcome measure(s)
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To assess the feasibility of a randomised controlled trial (RCT), in particular, recruitment at 6 and/or 12 months
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Secondary outcome measure(s)
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1. At 12 months we will assess the acceptability of the intervention and help refine it
2. Proportion of patients with at least one repetition of self-harm within 6 and/or 12 months
3. Assess resource use in order to pilot collection of such data
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Sources of funding
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National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
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Trial website
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Publications
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Contact name
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Dr
Jayne
Cooper
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Address
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Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Email
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jayne.cooper@manchester.ac.uk
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Sponsor
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University of Manchester (UK)
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Address
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Centre for Suicide Prevention
Room 2.320
University Place
Oxford Road
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City/town
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Manchester
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Zip/Postcode
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M13 9PL
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Country
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United Kingdom
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Sponsor website:
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http://www.manchester.ac.uk/
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Date applied
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24/06/2010
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Last edited
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01/07/2010
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Date ISRCTN assigned
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24/06/2010
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