Contact and information after self-harm pilot study

ISRCTN	ISRCTN65171515
DOI	https://doi.org/10.1186/ISRCTN65171515
Protocol serial number	8434
Sponsor	University of Manchester (UK)
Funder	National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)

Submission date: 24/06/2010
Registration date: 24/06/2010
Last edited: 03/07/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jayne Cooper
Scientific

Oxford Road
Manchester
M13 9PL
United Kingdom

Email	jayne.cooper@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Single centre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A pilot study of a contact and information based intervention to reduce repeat self-harm
Study objectives	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.
Ethics approval(s)	North West 9 Research Ethics Committee - Greater Manchester West approved on the 24th May 2010 (ref: 10/H1014/35)
Health condition(s) or problem(s) studied	Topic: Mental Health Research Network; Subtopic: Suicide and self-harm; Disease: Suicide and self harm
Intervention	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
Intervention type	Other
Primary outcome measure(s)	To assess the feasibility of a randomised controlled trial (RCT), in particular, recruitment at 6 and/or 12 months
Key secondary outcome measure(s)	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
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	100
Key inclusion criteria	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.
Key exclusion criteria	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
Date of first enrolment	01/04/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oxford Road

Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes