Condition category
Mental and Behavioural Disorders
Date applied
27/04/2012
Date assigned
03/05/2012
Last edited
03/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Suicide is a national priority and a history of self-harm is its best predictor. Much research effort has been directed at reducing self-harm (SH) and by implication the risk of suicide. Psychosocial interventions (treatment) targeted at those who self-harm have been shown to offer promise in terms of reducing SH repetition. However, one of the major issues with delivering such interventions is that it is very difficult to maintain patients who self-harm in treatment. As a result, it is desirable to intervene more while the patient is in hospital to reduce risk. This study will investigate whether a new, low intensity psychosocial intervention, the volitional help sheet (VHS), has utility in reducing SH. This study will address three research questions:
1. Does VHS reduce the number of people who re-present to hospital with SH in the six months following an index episode of SH?
2. Does a VHS reduce the number of SH episodes per person in the six months following an index episode of SH? and
3. What is the incremental cost of the VHS per SH event averted?

Who can participate?
All male and female patients over the age of 16 years, with a history of self-harm, who have been admitted to the Combined Assessment Area 6 (Royal Infirmary of Edinburgh), with suicidal self-harm can participate.

What does the study involve?
Participants who have presented to hospital following suicidal self-harm will be randomised into either the intervention (treatment as usual + VHS) or control (treatment as usual) arms of the study. At Time 2, six months later, we will determine whether the intervention had an effect on re-presentation to hospital for self-harm. The study involves answering questions about psychological well-being, current and previous self-harm episodes and depending on the arm of the study, some participants will be asked to complete the help sheet.

What are the possible benefits and risks of participating?
There are no risks associated with taking part in the study but participants may find it beneficial to take part as it may help them to stop self-harming again in the future.

Where is the study run from?
The project will take place in the Royal Infirmary of Edinburgh.

When is study starting and how long is it expected to run for?
The study will run for 36 months between April 2012 and April 2015.

Who is funding the study?
Chief Scientist Office of the Scottish Executive Health Department (UK)

Who is the main contact?
Professor Rory O’Connor
rory.oconnor@stir.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rory O'Connor

ORCID ID

Contact details

Institute of Health & Wellbeing
College of Medical
Veterinary and Life Sciences
University of Glasgow
Mental Health & Wellbeing Academic Centre
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3924
rory.oconnor@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CZH/4/704

Study information

Scientific title

A volitional help sheet to reduce self-harm among people admitted to hospital for self-harm: a randomised controlled trial

Acronym

Study hypothesis

1. Does a Volitional Help Sheet reduce the number of people who re-present to hospital with self-harm in the six months following an index episode of self-harm?
2. Does a Volitional Help Sheet reduce the number of self-harm episodes per person in the six months following an index episode of self-harm?
3. What is the incremental cost per self-harm event averted?

Updated 03/09/2014: The data collection phase of the trial has finished as of May 2014.

Ethics approval

Lothian NHS Board, South East Scotland Research Ethics Committee, 07/02/2012, ref: 12/SS/0012

Study design

Single-centre randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hospital treated self-harm

Intervention

At baseline, participants in both the intervention and control group will receive treatment as usual and will complete standard demographic measures as well as a number of clinical/psychological measures.

In addition to this, participants in the Intervention group will complete the Volitional Help Sheet with the assistance of the research assistant. The Volitional Help Sheet will be produced such that a carbon copy will be available. Upon completion of the help sheet, participants will be asked to take a copy home with them and encouraged to refer to it at home. The research assistant will keep the other copy.

Approximately 2 months post baseline, all those in the intervention group will be sent a single booster help sheet. The booster will involve re-sending a copy of the completed help sheet and in the covering letter a summary of the solutions and associated critical situations that the participant thought might be helpful at baseline.

Six months following baseline, data will be extracted by the Information Services Division (ISD) if the NHS National Services Scotland. ISD maintains a national database of hospital records and mortality data. This nationally linked database will allow us to determine whether a patient has been re-admitted to hospital anywhere in Scotland with self–harm at any time since their index episode. This information will be extracted for each participant.

As copies of the self-help sheets will be kept, fidelity checks can be conducted on the administration of the intervention. In addition to this, during the data collection phase, a member of the research team will sit in on a random selection of participant assessments to monitor adherence to trial protocol.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Whether a participant re-presented to any hospital in Scotland with self-harm during the follow up period of six months
2. How many times a participant re-presented at hospital with self-harm during the six month follow up period. All of this information will be gathered from data from the nationally linked database held by the Information Services Division (ISD) of the NHS National Services Scotland.
3. Cost effectiveness of the self-help sheet, as measured by estimated incremental cost per self-harm event/suicide averted

Secondary outcome measures

Time to representation at hospital with self-harm within the six month follow up period. This will be measured in weeks/months and this information will be gathered from data from the nationally linked database held by the Information Services Division (ISD) of the NHS National Services Scotland.

Overall trial start date

19/04/2012

Overall trial end date

19/04/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients admitted to the Combined Assessment Area 6 of Royal Infirmary of Edinburgh with self-harm
2. Those with a past history of self-harm
3. Those with suicidal intent (associated with the present episode)
4. Age 16 + years no upper age range

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

We aim to recruit 518 people into the trial (259 in each arm)

Participant exclusion criteria

1. Those below 16 years old
2. Those with no reported suicidal intent (associated with the present episode)
3. Those with no past history of self-harm prior to the index episode
4. Patients who are unfit for interview
5. Those from who informed consent cannot be gained
6. Those patients for whom English is not their first language
7. Those who are participating in other research at the Royal Infirmary of Edinburgh
8. Those that present at the emergency department but are subsequently discharged without hospital admission

Recruitment start date

19/04/2012

Recruitment end date

19/04/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of Health & Wellbeing
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

University of Stirling (UK)

Sponsor details

Research and Enterprise Office
Stirling
FK9 4LA
United Kingdom
+44 (0)1786 466690
carol.johnstone@stir.ac.uk

Sponsor type

University/education

Website

http://www.stir.ac.uk/

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department (UK) ref: CZH/4/704

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

Publication citations

Additional files

Editorial Notes