Contact and information after self-harm pilot study
| ISRCTN | ISRCTN65171515 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65171515 |
| Secondary identifying numbers | 8434 |
- 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
Scientific
Oxford Road
Manchester
M13 9PL
United Kingdom
| jayne.cooper@manchester.ac.uk |
Study information
| 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 |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 |
| Completion date | 30/09/2011 |
Eligibility
| 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 |
| 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
- England
- United Kingdom
Study participating centre
Oxford Road
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
Centre for Suicide Prevention
Room 2.320
University Place
Oxford Road
Manchester
M13 9PL
England
United Kingdom
| Website | http://www.manchester.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/027m9bs27 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grant for Applied Research (PGfAR)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
