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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27630071