Condition category
Mental and Behavioural Disorders
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
03/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jayne Cooper

ORCID ID

Contact details

Oxford Road
Manchester
M13 9PL
United Kingdom
jayne.cooper@manchester.ac.uk

Additional identifiers

EudraCT 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2010

Overall trial end date

30/09/2011

Reason abandoned

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

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk/

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23818535

Publication citations

  1. Results

    Kapur N, Gunnell D, Hawton K, Nadeem S, Khalil S, Longson D, Jordan R, Donaldson I, Emsley R, Cooper J, Messages from Manchester: pilot randomised controlled trial following self-harm., Br J Psychiatry, 2013, 203, 1, 73-74, doi: 10.1192/bjp.bp.113.126425.

Additional files

Editorial Notes