FReSH START RCT

University of Leeds requires access to NHS England data for the purpose of the following research project:

Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy: FReSH START

The following is a summary of the aims of the research project provided by University of Leeds):

“The FReSH START trial is a multi-centre individually Randomised Controlled Trial comparing the effectiveness of a psychological intervention to standard care according to National Institute for Health and Care Excellence (NICE) guidelines, including an internal pilot, embedded qualitative study and comprehensive cost-effectiveness analysis.

The National Suicide Prevention Strategy in England highlighted self-harm (SH) as a key issue and it remains central to the fourth update of the strategy in 2019, as it is the strongest factor associated with subsequent suicide. There are over 200,000 hospital attendances for self-harm per annum in the UK and approximately 100,000 acute hospital admissions, at an estimated cost of between £133-162 million per year.

In terms of treatment approach, it is useful to distinguish acts of SH that are a response to recent stressors and are associated with acute distress, and multiple (repeated) acts that are associated with longer-term individual psychological problems.

Repeated self-harm especially is associated with other problems such as depression and misuse of alcohol, with poor quality of life and with problems with interpersonal and social function: the risk of suicide is higher in the presence of a history of repeated episodes.

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 tens of thousands of those who attend hospital each year. The FReSH START RCT is part of a wider 8 year research programme which commenced in 2018, funded by NIHR PGfAR, which seeks to develop and evaluate an intervention to improve outcomes in people who repeatedly self-harm. The intervention modifies three existing psychological therapies Cognitive behavioural therapy, Acceptance and commitment therapy and Psychodynamic Interpersonal Therapy (CBT, ACT, PIT) to target factors leading to repeated self-harm and associated psychological problems, aiming to improve quality of life and minimise self-damaging behaviour”

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

o Outpatients – required to derive cost-effectiveness outcomes.

• Emergency Care Data Set (ECDS) – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

• Mental Health (MHSDS) – required to derive cost-effectiveness outcomes.

• Civil Registration Mortality – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

• Medicines dispensed in Primary Care (NHSBSA data) – necessary to support the cost-effectiveness analysis and descriptive analysis of usual care/treatment services accessed for the participant cohort alongside trial interventions, providing more accurate and complete data than would usually be obtained via participant self-report. NHSBSA data is required to investigate the use of high-cost drugs in particular, which may contribute substantially to the costs of patient care, and identify differences in medication use attributable to the intervention, supporting accurate policy conclusions about whether or not the intervention is cost-effective.

The level of the Data will be:

• Identifiable – necessary to enable linkage of the data with data collected from other sources, including clinical data and Patient Reported Outcome Measures.

The Data will be minimised as follows:

• Limited to a study cohort of 348 patients who consented to participate

• Limited to data between 2021/22 and 2025/26

• Limited to the following geographic areas: England and Wales.

Patients meet the following criteria;

• Aged 18 years or over

• Registered with a GP in the catchment area of the mental health trust for the duration of the therapy

• Presenting at Accident and Emergency as a consequence of self-harm, defined as: intentional acts that directly harm a person’s own body. This includes methods like cutting, burning, scratching, banging or hitting parts of the body, or interfering with wound healing and it also includes self-poisoning, such as taking overdoses of drugs.

• Self-harm episode in the preceding three months that is at least their third episode in the preceding 12 months and their lifetime fourth or more episodes.

• Has the mental capacity to provide fully informed written consent.

University of Leeds is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

Leeds and York Partnership NHS Foundation Trust provides funding to the University of Leeds to undertake the work. Leeds and York Partnership NHS Foundation Trust does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by University of Leeds.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by NIHR Programme Grants for Applied Research. The funding is specifically for the research project described.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Microsoft Limited is a processor acting under the instructions of the University of Leeds. Microsoft Limited’s role is limited to providing secure off-site backup services.

AQL limited host the University of Leeds colocation facility in a commercial datacentre on the other side of Leeds City centre. In all locations data is stored encrypted on disk. All equipment is University of Leeds owned and connects only to the University of Leeds network.

Data will be accessed by substantive employees of the University of Leeds.

The Lived Experience Group will help inform the dissemination strategy and its members will play an active role in the format and content of academic papers and will support presentation at local, regional and national conferences and wider stakeholder meetings.

A Public and Patient Involvement group have been involved throughout the trial to help refine the purpose of the research and review trial processes. The group supports the collection of the data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to NIHR, with the first draft of the final report being targeted for July 2026.

• Submissions to peer reviewed journals by July 2026

• Presentations at relevant conferences linked to liaison mental health and self-harm

• Presentations at local, regional and national conferences and wider stakeholder meetings.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals (specifically in relation to implications for people with experience of self-harm)

• Social media

• Direct bilateral engagement with stakeholders, including both scientific and policy-making audiences.

• Lay summaries will be added to the trial website (https://freshstart.leeds.ac.uk/)

• Trial registry (https://doi.org/10.1186/ISRCTN73357210) will be updated.

• other public promotion of research utilising the study team’s networks, including clinical networks, scientific networks and charitable organisations.

• Summaries provided to participating sites.

• network of champions (people with experience of self-harm, staff and other stakeholders)

• change in the NICE guidelines.

The study team plan to have their analysis completed by April 2026. The study team expect to commence drafting of publications shortly after. The study team aim to publish main trial results in July 2026.

University of Leeds requires access to NHS England data for the purpose of the following research project:

Function REplacement in repeated Self-Harm: Standardising Therapeutic Assessment and the Related Therapy: FReSH START

The following is a summary of the aims of the research project provided by University of Leeds):

“The FReSH START trial is a multi-centre individually Randomised Controlled Trial comparing the effectiveness of a psychological intervention to standard care according to National Institute for Health and Care Excellence (NICE) guidelines, including an internal pilot, embedded qualitative study and comprehensive cost-effectiveness analysis.

The National Suicide Prevention Strategy in England highlighted self-harm (SH) as a key issue and it remains central to the fourth update of the strategy in 2019, as it is the strongest factor associated with subsequent suicide. There are over 200,000 hospital attendances for self-harm per annum in the UK and approximately 100,000 acute hospital admissions, at an estimated cost of between £133-162 million per year.

In terms of treatment approach, it is useful to distinguish acts of SH that are a response to recent stressors and are associated with acute distress, and multiple (repeated) acts that are associated with longer-term individual psychological problems.

Repeated self-harm especially is associated with other problems such as depression and misuse of alcohol, with poor quality of life and with problems with interpersonal and social function: the risk of suicide is higher in the presence of a history of repeated episodes.

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 tens of thousands of those who attend hospital each year. The FReSH START RCT is part of a wider 8 year research programme which commenced in 2018, funded by NIHR PGfAR, which seeks to develop and evaluate an intervention to improve outcomes in people who repeatedly self-harm. The intervention modifies three existing psychological therapies Cognitive behavioural therapy, Acceptance and commitment therapy and Psychodynamic Interpersonal Therapy (CBT, ACT, PIT) to target factors leading to repeated self-harm and associated psychological problems, aiming to improve quality of life and minimise self-damaging behaviour”

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

o Outpatients – required to derive cost-effectiveness outcomes.

• Emergency Care Data Set (ECDS) – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

• Mental Health (MHSDS) – required to derive cost-effectiveness outcomes.

• Civil Registration Mortality – required to derive the key secondary outcomes relating to repetition of self-harm leading to hospital attendance, and safety outcomes.

• Medicines dispensed in Primary Care (NHSBSA data) – necessary to support the cost-effectiveness analysis and descriptive analysis of usual care/treatment services accessed for the participant cohort alongside trial interventions, providing more accurate and complete data than would usually be obtained via participant self-report. NHSBSA data is required to investigate the use of high-cost drugs in particular, which may contribute substantially to the costs of patient care, and identify differences in medication use attributable to the intervention, supporting accurate policy conclusions about whether or not the intervention is cost-effective.

The level of the Data will be:

• Identifiable – necessary to enable linkage of the data with data collected from other sources, including clinical data and Patient Reported Outcome Measures.

The Data will be minimised as follows:

• Limited to a study cohort of 348 patients who consented to participate

• Limited to data between 2021/22 and 2025/26

• Limited to the following geographic areas: England and Wales.

Patients meet the following criteria;

• Aged 18 years or over

• Registered with a GP in the catchment area of the mental health trust for the duration of the therapy

• Presenting at Accident and Emergency as a consequence of self-harm, defined as: intentional acts that directly harm a person’s own body. This includes methods like cutting, burning, scratching, banging or hitting parts of the body, or interfering with wound healing and it also includes self-poisoning, such as taking overdoses of drugs.

• Self-harm episode in the preceding three months that is at least their third episode in the preceding 12 months and their lifetime fourth or more episodes.

• Has the mental capacity to provide fully informed written consent.

University of Leeds is the research sponsor and the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

Leeds and York Partnership NHS Foundation Trust provides funding to the University of Leeds to undertake the work. Leeds and York Partnership NHS Foundation Trust does not specify what data are required to deliver the work nor how the data shall be processed to achieve that purpose. Such decisions are taken by University of Leeds.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by NIHR Programme Grants for Applied Research. The funding is specifically for the research project described.

The funder will have no ability to suppress or otherwise limit the publication of findings.

Microsoft Limited is a processor acting under the instructions of the University of Leeds. Microsoft Limited’s role is limited to providing secure off-site backup services.

AQL limited host the University of Leeds colocation facility in a commercial datacentre on the other side of Leeds City centre. In all locations data is stored encrypted on disk. All equipment is University of Leeds owned and connects only to the University of Leeds network.

Data will be accessed by substantive employees of the University of Leeds.

The Lived Experience Group will help inform the dissemination strategy and its members will play an active role in the format and content of academic papers and will support presentation at local, regional and national conferences and wider stakeholder meetings.

A Public and Patient Involvement group have been involved throughout the trial to help refine the purpose of the research and review trial processes. The group supports the collection of the data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to NIHR, with the first draft of the final report being targeted for July 2026.

• Submissions to peer reviewed journals by July 2026

• Presentations at relevant conferences linked to liaison mental health and self-harm

• Presentations at local, regional and national conferences and wider stakeholder meetings.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the datasets from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Journals (specifically in relation to implications for people with experience of self-harm)

• Social media

• Direct bilateral engagement with stakeholders, including both scientific and policy-making audiences.

• Lay summaries will be added to the trial website (https://freshstart.leeds.ac.uk/)

• Trial registry (https://doi.org/10.1186/ISRCTN73357210) will be updated.

• other public promotion of research utilising the study team’s networks, including clinical networks, scientific networks and charitable organisations.

• Summaries provided to participating sites.

• network of champions (people with experience of self-harm, staff and other stakeholders)

• change in the NICE guidelines.

The study team plan to have their analysis completed by April 2026. The study team expect to commence drafting of publications shortly after. The study team aim to publish main trial results in July 2026.

Yielded Benefits is not a requirement for new applications.