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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Else Guthrie
+44 (0)1133432442
e.a.guthrie@leeds.ac.uk


Dr - Trial Manager
-
freshstart@leeds.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - FReSH START – Looking at new approaches for people who self-harm
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FReSH START – Looking at new approaches for people who self-harm

Recruiting

Open to: All Genders

Age: Adult

Manchester Ashton-under-lyne Maidstone Sheffield Preston Leeds Darlington Cambridge Gloucester

Medical Conditions

Self harm

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Self-harm is a major public health challenge with an estimated lifetime prevalence of 5-6% and 220,000 hospital attendances annually in England and Wales. Repetition of self-harm is common with 70% of hospital attenders reporting previous episodes of self-harm. An intervention that improves the quality of life of people who repeatedly self-harm and that could be delivered without the need for expensive specialist services would be of potential benefit to many who attend hospital each year.
We know from working with people who have experience of self-harm that a therapeutic approach that works with service users to identify valued (positive) goals is a more acceptable approach than therapies focused on the reduction of the act itself. Our approach involves modifying three existing therapies specifically for use with people who self-harm.
This study is a large scale definitive individually randomised controlled trial of the therapies, recruiting 630 participants across 12 NHS sites.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

25 Oct 2021 31 Jan 2025

Publications

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39187855/ (added 02/09/2024)

If a participant agrees to take part they will need to do the following:
-Meet a researcher who will ask them about their health and their self-harm. They will also be asked to complete 4 questionnaires about their well-being, and 1 about money they may have spent related to self-harm.
-If they are allocated to the intervention group: attend up to 12 sessions of therapy with a trained therapist over a maximum of 6 months. These sessions will each take about 45 minutes. The sessions will either take place at their local NHS Trust premises or via phone or video call.
-If they are allocated to the standard care group: they will receive the care that your Trust normally provides to people who self-harm.
-Respond to monthly secure text messages to let us know how they are doing, and whether they have self-harmed in the last month.
-Complete the same set of questionnaires they filled out at the start of the study, online (or if this is not possible by post) after 6 and 12 months. We will send them a text message or email to let them know when and how to complete the questionnaire.
-Complete a much shorter questionnaire at 3 and 9 months, when we will ask them about hospital attendances, appointments and contact with other services.
-The researcher may invite them to take part in an optional interview after 12 months so that they can tell us about the therapy they received.


Adults over 18 years, who have had several episodes of self-harm behaviour in the past 12 months.

You can take part if:



You may not be able to take part if:


1. Receiving, or having been referred to (and likely to receive this within the next 6 months), a specific psychological intervention that is similar to the trial intervention, or where a specific intervention is indicated for a related condition (e.g. anorexia nervosa or drug addiction) and would conflict with trial participation.2. Taken part in the FReSH START Feasibility study3. Assessed by clinician to currently be unsuitable for therapy (e.g. in crisis; actively suicidal, unable to tolerate therapy - i.e. past talking treatments have resulted in severe deterioration of mental state, has a diagnosis of schizophrenia, autism, or other form of severe mental illness that would be a contraindication for the talking treatments in this study - n.b. people with schizophrenia are offered CBT but it is tailored specifically to help with psychotic experiences. The CBT in this study is not specifically tailored for the needs of people with schizophrenia)4. Lacking capacity to comply with study requirements5. Insufficient proficiency in English to contribute to the data collection6. Known risk of violence (for example reported by ED or liaison psychiatry staff)7. Researcher unable to contact potential participant within 6 weeks following self-harm event


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Greater Manchester Mental Health NHS Foundation Trust
    Prestwich Hospital Bury New Road Prestwich
    Manchester
    M25 3BL
  • Pennine Care NHS Foundation Trust
    225 Old Street
    Ashton-under-lyne
    OL6 7SR
  • Kent And Medway NHS and Social Care Partnership Trust
    Farm Villa Hermitage Lane
    Maidstone
    ME16 9PH
  • Sheffield Health & Social Care NHS Foundation Trust
    Fulwood House Old Fulwood Road
    Sheffield
    S10 3TH
  • Lancashire & South Cumbria NHS Foundation Trust Hq
    Sceptre Point Sceptre Way Bamber Bridge
    Preston
    PR5 6AW
  • Leeds and York Partnership NHS Foundation Trust
    2150 Century Way Thorpe Park
    Leeds
    LS15 8ZB
  • Tees, Esk and Wear Valleys NHS Foundation Trust
    Trust Headquarters West Park Hospital Edward Pease Way
    Darlington
    DL2 2TS
  • Cambridgeshire and Peterborough NHS Foundation Trust
    Elizabeth House, Fulbourn Hospital Fulbourn
    Cambridge
    CB21 5EF
  • Gloucestershire Health and Care NHS Foundation Trust
    Edward Jenner Court 1010 Pioneer Avenue Gloucester Business Park
    Gloucester
    GL3 4AW

• If they are randomised to the intervention group and attend the therapy sessions, we hope that these might help them but we cannot say that the participants will definitely feel better.
• Whichever group a participant is in, even if there is no direct benefit to them, they will be helping us to learn more about how to support people who self-harm.
• Completing the questionnaires will take a little of the participant’s time. We will adhere to all government and NHS guidance with regard to COVID-19. We do not expect there to be any risks in taking part, although some of these questionnaires ask about how they are feeling and may upset some people. The researcher will provide the participants with details of organisations that they can contact if the research upsets them in any way.

Dr - Trial Manager
-
freshstart@leeds.ac.uk


Prof Else Guthrie
+44 (0)1133432442
e.a.guthrie@leeds.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Leeds and funded by NIHR Central Commissioning Facility (CCF); National Institute for Health Research (NIHR) (UK).



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Read full details for Trial ID: ISRCTN73357210

Or CPMS 49617

Last updated 16 September 2024

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