Contact information
Type
Scientific
Contact name
Dr Jayne Cooper
ORCID ID
Contact details
Oxford Road
Manchester
M13 9PL
United Kingdom
jayne.cooper@manchester.ac.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
8434
Study information
Scientific title
A pilot study of a contact and information based intervention to reduce repeat self-harm
Acronym
Study hypothesis
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)
Study design
Single centre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
To assess the feasibility of a randomised controlled trial (RCT), in particular, recruitment at 6 and/or 12 months
Secondary outcome measures
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
Overall study start date
01/04/2010
Overall study end date
30/09/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant 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
Recruitment start date
01/04/2010
Recruitment end date
30/09/2011
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
Centre for Suicide Prevention
Room 2.320
University Place
Oxford Road
Manchester
M13 9PL
England
United Kingdom
Sponsor type
University/education
Website
ROR
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | results | 01/07/2013 | Yes | No |