Condition category
Mental and Behavioural Disorders
Date applied
18/11/2013
Date assigned
29/01/2014
Last edited
16/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of the study is to investigate if a new social intervention can help people who have self-harmed (for example: taken an overdose of tablets) or may have thoughts of doing so.

Who can participate?
People who have been attending hospital following an episode of self-harm, or who have been referred by their GP to primary mental health care services because of self harm or thoughts of self harm.

What does the study involve?
Participants are randomly allocated to either receive the intervention or treatment as usual. Participants receiving the intervention have contact with a trained professional for 4-6 weeks. The help provided is basically a talking therapy, and participants are encouraged to engage with other services who can help them with social issues (for example with relationships or finances). The practitioner makes referrals where necessary and supports the person in contacting services where relevant. Both groups are assessed three times over three months to see if there is any difference between those who receive the intervention and those who do not.

What are the possible benefits and risks of participating?
We hope that the intervention will lead to fewer re-hospitalisations and improved quality of life. Participants will be paid £10 in high street vouchers after the first assessment and then at the end of the study when they have completed both the 4-week and 12-week assessments they will receive a further £20 in vouchers. The only risks are that the participants will already be in an emotional state and might find the help provided causes them some further upset; however, to help them to learn to cope with their life events this is an essential part of the process and the researchers working on this project are experienced mental health workers.

Where is the study run from?
Swansea University (UK)

When is the study starting and how long is it expected to run for?
January 2014 to May 2016

Who is funding the study?
National Institute for Social Care and Health Research (UK)

Who is the main contact?
Dr Nilufar Ahmed
n.ahmed@swansea.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Huxley

ORCID ID

Contact details

ILS2
Swansea University
Singeton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 602651
p.j.huxley@swansea.ac.uk

Type

Scientific

Additional contact

Dr Nilufar Ahmed

ORCID ID

Contact details

27 Haldane Building
Swansea University
Singleton Park
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 602819
n.ahmed@swansea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16229

Study information

Scientific title

Social Work intervention following self-harm: a feasibility study for a replication of a successful intervention developed in Australia

Acronym

SWISH

Study hypothesis

Current hypothesis as of 02/02/2016:
A social intervention will produce better outcomes in depression and wellbeing than treatment as usual.

Previous hypothesis:
That the SWISH intervention produces better outcomes than treatment as usual.

Ethics approval

South West Wales Ethics Committee (Wales REC 6), 28/05/2014, ref: 14/WA/0074

Study design

Parallel randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Deliberate self-harm and/or suicidal ideation

Intervention

Current interventions as of 02/02/2016:
Participants are randomised to either receive the intervention or treatment as usual.

The intervention is a 4-6 week contact programme comprised of a mix of face to face and telephone contact. Patients are encouraged to discuss the circumstances that led to their presentation with the SWISH practitioner and identify social factors which can be addressed. The SWISH practitioner will help the patient engage with community services. SWISH is more than signposting, it assertively links individuals with existing support services. Additionally it keeps patients engaged with services as they wait for appointments which they may have been referred to as part of their treatment as usual.

Treatment as usual ranges from discharge with no further follow up; discharge to general practitioner; signposting to community services

Previous interventions:
Participants are allocated randomly to the SWISH intervention or treatment as usual. A research worker will assess 60 eligible candidates at baseline, six weeks and three months. The intervention was developed in Australia, and consists of an individualised talking therapy and practical help. It has now been manualised and this will form the basis of our intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 02/02/2016:
Symptoms of depression measured using Beck Depression Inventory. Measured at baseline, four weeks and three months.

Previous primary outcome measures:
Symptoms of depression measured using Beck Depression Inventory. Measured at baseline, six weeks and three months.

Secondary outcome measures

Current secondary outcome measures as of 02/02/2016:
1. Manchester Short Assessment of Quality of Life (MANSA)
2. Service contacts that the person has had in a defined period measured using Client Service Receipt Inventory (CSRI)
Measured at baseline, four weeks and three months.

Previous secondary outcome measures:
1. Manchester Short Assessment of Quality of Life (MANSA)
2. Service contacts that the person has had in a defined period measured using Client Service Receipt Inventory (CSRI)
Measured at baseline, six weeks and three months.

Overall trial start date

01/01/2014

Overall trial end date

31/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 02/02/2016:
Person aged 18 or over who presents to Mental Health Services (either directly at hospital or indirectly through referral from General Practitioner to Local Primary Mental Health Support Services) with self-harm and/or suicidal ideation

Previous inclusion criteria:
1. Admitted with first episode of self-harm
2. No contact with psychiatric services in the last two years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

Current exclusion criteria as of 02/02/2016:
Anyone who, following a psychosocial assessment by a Mental Health Practitioner, is:
1. Unable to give informed consent
2. So unwell that they have to be admitted to a psychiatric bed
3. Requires secondary mental health services
4. Assessed as high risk for violence
5. Known or assessed to have a severe mental illness and require other services
6. Is under a current and active care treatment plan with Adult Mental Health Services
7. Is unable to communicate in English

Previous exclusion criteria:
1. Too unwell to participate according to direct care staff
2. Referred for psychiatric assessment or treatment
3. Unable to communicate in English or Welsh

Recruitment start date

01/01/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glangwili General Hospital
Swansea
SA31 2AF
United Kingdom

Trial participating centre

Prince Philip Hospital
SA14 8QF
United Kingdom

Sponsor information

Organisation

Swansea University (UK)

Sponsor details

Department of Research and Innovation
Digital Technium
Swansea
SA2 8PP
United Kingdom
-
contact@dri.swansea.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

National Institute for Social Care and Health Research

Alternative name(s)

Sefydliad Cenedlaethol ar Gyfer Ymchwil Gofal Cymdeithasol ac Lechyd, NISCHR

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The study report will be provided to funders for publication in June 2016

Further publications planned:
1. Study protocol to submit for publication February 2016
2. A systematic review on self-harm interventions to submit for publication March 2016
3. Social outcomes and self-harm paper to submit TBC
4. Findings papers to submit TBC

Dissemination plan:
1. Present at service user forums
2. Present at academic conferences
3. Produce information on findings to send to all participants
4. Present at Health Board strategic and service planning meetings

Intention to publish date

01/06/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27630071

Publication citations

Additional files

Editorial Notes

16/09/2016: Publication reference added. 02/02/2016: the following changes were made to the trial record: 1. The overall trial end date was changed from 30/09/2015 to 31/05/2016. 2. The target number of participants was changed from 60 to 120.