The role of IAPT in the prevention of dementia and the amelioration of its impact on service use and co-morbidities (the MODIFY project)

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Civil Registrations of Death

Objective for processing

The MODIFY project, otherwise known as “Mental health and other psychological therapy Outcomes; their relationship to Dementia Incidence in the Following Years”, is funded by the Alzheimer's Society* and led by University College London (UCL) researchers. UCL are the (sole) Data Controller for this study who also processes the data. MODIFY aims to enhance understanding of dementia prevention in the UK by examining the role of psychological therapies offered within the England-wide Improving Access to Psychological Therapies (IAPT) services in dementia prevention. University College London (UCL) requires access to NHS England data for the purpose of the following research project: *Originally, this study aimed to only look at dementia incidences and thus obtained funding by the Alzheimer's Society. The study has now expanded its scope to cover other mental health conditions (described below). This additional scope is funded by UCL and not by the Alzheimer's Society. UCL have discussed this expansion with the Alzheimer's Society who have expressed their awareness and are happy with this extension. For clearness, the Alzheimer's Society funding does not scope beyond dementia. The role of IAPT in the prevention of dementia and the amelioration of its impact on service use and co-morbidities (The MODIFY project) The following is a summary of the aims of the research project provided UCL: The MODIFY project, otherwise known as “Mental health and other psychological therapy Outcomes; their relationship to Dementia Incidence in the Following Years”, aims to enhance understanding of dementia prevention in the UK by examining the role of psychological therapies offered within the England-wide Improving Access to Psychological Therapies (IAPT) services in dementia prevention. [1 paragraph unchanged] UCL are requesting to repurpose the current agreement and build on UCL’s findings from the MODIFY project will be used to further explore inequalities in access to, and outcomes from, IAPT services. [21 words unchanged] in access and differential outcomes for individuals with dementia referred to IAPT. In UCL extended this repurposing addition, UCL propose to extend this analysis to further groups of patients where there is a policy focus on [28 words unchanged] disease, diabetes, respiratory conditions, multimorbidity) and people from minoritised ethnic groups. This repurposing of will support UCL in understanding the MODIFY dataset to understand outcomes and access issues for these groups which will be very helpful in meeting NHS long term plan objectives around reducing inequalities in their access to and outcomes from health services. The cohort consists of anyone with an IAPT record including, but not limited to, those with a linked record in the other datasets. UCL will also look into the possibility of measuring change due to other risk factors not treated in IAPT interventions, such as poor sleep, loneliness, isolation, physical inactivity and high alcohol use. If this is possible, it could lead to further research into whether psychological therapy may help to prevent dementia by changing other risk factors of dementia. Young-onset dementia is typically defined as emerging from age 30 onwards, therefore the MODIFY project would like to capture this often ignored group of people with early-onset dementia in data analysis. UCL confirm that this resource and the data within it will not be used for any other studies other than as described in this data-sharing agreement. UCL have ensured there is no other way of answering these research questions, especially the linkage needed between healthcare records. UCL will also look into the possibility of measuring change due to other risk factors not treated in IAPT interventions, such as poor sleep, loneliness, isolation, physical inactivity and high alcohol use. If this is possible, it could lead to further research into whether psychological therapy may help to prevent dementia by changing other risk factors of dementia. Young-onset dementia is typically defined as emerging from age 30 onwards, therefore the MODIFY project would like to capture this often ignored group of people with early-onset dementia in data analysis. The lawful basis for the MODIFY project is a ‘public task’ which sits within UCL’s research core principles as a public authority per guidance issued by the UK Information Commissioner’s Office (ICO), and for both UCL and NHS England, and associated partners. The processing of the requested data is necessary to achieve the objectives of the MODIFY project, and have taken measures to minimise the data requested to remove potential identifiers. Data Minimisation: • Only periods necessary for analysis have been requested (from the start of IAPT data 2012 to the latest available). • Identifiable data is not required. • Only fields necessary for analyses of the prevention of dementia or amelioration of its co-morbidities or impacts on health and service use (e.g. the entire maternity category is omitted) have been included • Only those with an IAPT record (no additional data in HES/MHDS) have been requested. [2 paragraphs unchanged] The aims of the research project are: - To investigate the effectiveness of psychological therapies provided through the IAPT services in reducing the risk of dementia and alleviating its impact on healthcare service utilisation and associated co-morbidities - Assess the relationship between treatment outcomes from the IAPT services and subsequent incidence of dementia, with a particular focus on evaluating whether psychological interventions effectively reduce key risk factors such as anxiety, depression, and social isolation. - Explore inequalities in access to and outcomes from IAPT services, especially among groups with neurodevelopmental disorders (e.g. autism, ADHD), intellectual disabilities, long-term physical health conditions (e.g. diabetes, cardiovascular disease), and minoritised ethnic groups. - Support NHS England’s long-term plan by identifying and addressing disparities in psychological therapy access and outcomes, and by informing strategies to improve service provision for underrepresented and vulnerable populations. - Generate evidence to guide policy, clinical practice, and training, with the goal of improving mental health services and contributing to dementia prevention efforts across England. The following NHS England Data will be accessed: • Hospital Episode Statistics - Admitted Patient Care - Accident & Emergency - Outpatients • Emergency Care Data Set (ECDS) • Mental Health Data • Civil Registration of Death • Demographics • Improving Access to Psychological Therapy (IAPT The above requested datasets, are necessary to examine whether psychological therapies provided through the Improving Access to Psychological Therapies are associated with reduced future risk of dementia, and to explore inequalities in access to and outcomes from these services among vulnerable groups. The level of the Data will be: • Pseudonymised The Data will be minimised as follows: - The cohort consists of anyone with an IAPT record including, but not limited to, those with a linked record in the other datasets. - Limited to data between 2012/13 to latest available. UCL 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. 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 the Alzheimer's Society and UCL. The funding is specifically for the project described. Originally, this study aimed to only look at dementia incidences and thus obtained funding by the Alzheimer's Society. The study over time expanded its scope to cover other mental health conditions (described above). This additional scope is funded by UCL and not by the Alzheimer's Society. UCL have discussed this expansion with the Alzheimer's Society who have expressed their awareness and are happy with this extension. For clearness, the Alzheimer's Society funding does not scope beyond dementia. The funders will have no ability to suppress or otherwise limit the publication of findings. Data will be accessed by: • Masters or PhD students enrolled with UCL. Any student working with the Data held under this Data Sharing Agreement (DSA) must have completed relevant data protection and confidentiality training and are subject to UCL's policies on data protection and confidentiality. Any students accessing the Data will do so under the supervision of a substantive employee of UCL. UCL would be responsible and liable for any work carried out by students. These students would only work on the Data for the purposes described in this DSA. • Individuals (from either University College Dublin or University Liverpool) holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract: • Their substantive employer; • Their role in respect of the purpose for the processing specified in the DSA; • The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract; • The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA; • Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder. The MODIFY project has actively involved members of the public, patients, and diverse communities in shaping its approach to data use. A stakeholder reference group, including individuals affected by dementia, IAPT service users, and clinicians have provided ongoing input. Public engagement has been further supported through presentations to groups like the Alzheimer’s Society Network and dissemination via patient-facing publications and social media. The project has also expanded to include underserved groups, such as those with neurodevelopmental disorders, intellectual disabilities, long-term health conditions, and minoritised ethnic communities, based on evidence of inequalities and feedback from service users.

Processing activities

NHS England will link Civil Registration Deaths, HES Admitted Patient Care, Outpatients, Accident & Emergency, Emergency Care Data Set, IAPT, Mental Health Services Data Set, Mental Health Maternity Services Data Set and Mental Health Learning Disabilities Data Set (all of which are held by NHS England) using a non-identifiable linking key. Aside from these internal NHS England linkages, there will be no other linkages of this data. The entire linked dataset will be pseudonymised and no identifiable variables have been included in the dataset. No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA). The data flow out of is NHS England Civil Reg Deaths, HES APC, OP, A&E, ECDS, IAPT, MHSDS, MHMDS, and MHLDDS, which includes special categories of pseudonymised health data going to the data safe haven at UCL. There will be no subsequent data flows out of UCL. There will be no flow of data into NHS England. NHS England will link IAPT data to Civil Registration Deaths, HES Admitted Patient Care, Outpatients, Accident & Emergency, Emergency Care Data Set, Mental Health Services Data Set, Mental Health Minimum Services Data Set and Mental Health Learning Disabilities Data Set using a non-identifiable linking key. The data is not being matched to publicly available data. Re-identification of individuals is not permitted under this agreement. NHS England will provide the relevant records from the Civil Registration Deaths, HES Admitted Patient Care, Outpatients, Accident & Emergency, Emergency Care Data Set, IAPT, Mental Health Services Data Set, Mental Health Minimum Services Data Set and Mental Health Learning Disabilities Data Set to UCL. The data will be held in the UCL data safe haven using UCL approved computers. The Data Safe Haven is UCL's technical solution for transferring and storing research information that is highly confidential. It meets the requirements of the NHS England Information Governance Toolkit and ISO 27001 Information Security standard. Access is controlled by the ‘Information Asset Owner’ and they complete training in confidentiality and data protection, which is renewed annually. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient. System access is from UCL approved computers and is secure requiring the user to enter a username as well as a randomly generated number on a device held by the user which is also combined with a pin and regularly updated password of specified length and complexity. The Data will not be transferred to any other location. No organisations other than UCL are involved in the planned data analysis. All those involved in the processing of the data are substantive employees of UCL, enrolled students of UCL MSc and doctorate courses and an individual working under honorary contract with UCL under the supervision of UCL substantive employees. Work under by the research team is only for the purpose stated in this Agreement. The Data will be stored on servers at UCL data safe haven No elements of the work will take place outside England and Wales. The Data will be accessed by authorised personnel via remote access. All individuals/UCL students are expected to undertake annual training on handling highly confidential information. All Trainees and students register for and complete NHS England’s Data Security Awareness (NHSD) course provided by e-Learning for Health. The course covers data security awareness, the law, threats to data security, breaches and incidents, and the General Data Protection Regulation. Completion of the course is sufficient evidence of basic information governance training to handle highly confidential information under the School of Life and Medical Sciences (SLMS) Information Governance Training Policy. Trainees'/students' up-to-date training is recorded in the SLMS IG training register. The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. All students working on the MODIFY project are students from UCL. All students working on the MODIFY project will undertake the NHS England’s Data Security Awareness course provided by e-Learning for Health. UCL has a specific data protection and information security policy, which applies to all staff and students when processing personal data on behalf of UCL. All UCL students working on the MODIFY project are bound by this policy, and they will face potential sanctions in the event of a breach of the policy. For remote access: All students sign up for the UCL's Academic Manual. The Student Academic Misconduct section of the 2019-2020 manual Section 9.1, item 3 states "All instances of Research Misconduct whether by taught students, research students or members of staff will be investigated under UCL’s Procedure for Investigating and Resolving Allegations of Misconduct in Academic Research". - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; All data in all outputs will be aggregated with small numbers suppressed as per the HES Analysis Guidance and the IAPT, ECDS and the Mental Health (MHSDS, MHLDDS, MHMDS) data sets Disclosure Policies. - Access controls granting users the minimum level of access required are in place; The analyses used following the expansion of the purpose (extending the study to further groups of patients were there is a policy focus on reducing inequalities in psychological therapy access and outcomes) is of the same type as those proposed for the original MODIFY analysis protocol. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; - Multifactor authentication (MFA) is required for remote access; - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). Remote processing will be from secure locations within the UK. The data will not leave the UK at any time. Data will be accessed by specific individuals with honorary contracts with UCL, from the University of Liverpool and University College Dublin respectively. The individuals will act as agents of UCL at all times under supervision from employees of UCL. Aside from these individuals, access is restricted to employees or agents of UCL who have authorisation from the Principal Investigator. No organisations other than UCL are permitted to access the Data. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. There will be no requirement and no attempt to reidentify individuals when using the Data.

Expected output

Under the previous iteration the outputs included progress reports to Alzheimer's Society, which were annual with the first report in July 2020, the next in 2021, and the final one in July 2022. These were submitted to the Alzheimer’s Society as planned. This report is intended for internal use only and is not published externally. The expected outputs of the processing will be: It is expected that several empirical papers will continue to be submitted to key relevant peer-reviewed journals such as the Lancet Psychiatry, the British Journal of Psychiatry, Alzheimer’s and Dementia and the International Journal of Geriatric Psychiatry. The first of these were submitted around the end of year 1 of the grant (July 2020 - https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2930367-6) with other publications submitted (or to be submitted) in the three years following that. • Submissions to peer reviewed journals such as The Lancet Psychiatry, British Journal of Psychiatry, Alzheimer’s and Dementia, and International Journal of Geriatric Psychiatry UCL presented this work to the Alzheimer’s Society Network group and also presented the work in a presentation to the Oxford Academic Health Science Network in July 2022. • Presentations at national and international conferences. All data in all outputs will be aggregated with small numbers suppressed as per the HES Analysis Guidance and the IAPT, ECDS and the Mental Health (MHSDS, MHLDDS, MHMDS) data sets Disclosure Policies. • Workshop and training sessions for Clinical psychology trainees and IAPT practitioners There will be an active process of dissemination of the project to relevant stakeholders as the project goes on. This will be done through ongoing engagement with the project stakeholder reference group (which includes people affected by dementia, IAPT service users and IAPT clinicians). There will be conference presentations detailed above to audiences that include clinicians, people affected by dementia, depression and anxiety, researchers and policymakers. Summaries of outputs will be published in patient-facing journals. The Alzheimer’s Society will publish results in their ‘care and cure’ magazine. • Production of Educational materials integrated into clinical training programs. The project also has links with AnxietyUK which will publish results in their newsletter. There will also be direct bilateral engagement with key figures in psychological therapy research and practice. For instance, the founder of IAPT services supported the funding application. Key publications, findings and conference presentations will be disseminated through UCL media channels (including collaborator and departmental Twitter accounts). Workshops based on findings will be run with the 150 clinical psychology trainees on the UCL clinical psychology doctorate of which the applicant is the Clinical Director. Findings will also be integrated into the IAPT training courses at UCL, over which the applicant, who is involved in the project and a substantive employee of UCL, has oversight. There are direct links to NICE and consequent policy influence through the director of the UCL Centre for Outcomes Research and Effectiveness who is involved with this project and is a substantive employee of UCL. IAPT service leads and senior practitioners in London IAPT services are collaborators on MODIFY and will take findings to senior trust meetings. These contacts in research, policy, clinical practice, dementia and IAPT service user movements will also facilitate the development of new relationships which will be used to disseminate findings further. 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 dataset(s) from which the information was derived. There will be active communication to ensure findings reach their intended audience. This will be through many of the dissemination activities and channels listed above and through a project website (https://www.adaptlab.net/modify) and promotion of research at conferences with large degrees of lay attendance (e.g. the Alzheimer’s Society Conference). The UCL and Alzheimer’s Society press offices will be contacted at the point of publication of papers or conference presentations to discuss potential dissemination in the wider media. Throughout, there will be consultation with the stakeholder steering group and other partners above as to how best to communicate findings. The outputs will be communicated to relevant recipients through the following dissemination channels: There will not be other exploitation of results or outputs. Only substantive employees of UCL, or students on UCL MSc and doctorate courses under the supervision of UCL substantive employees will have access to the data. All outputs outside of this will be aggregated with small numbers suppressed. • Journals v1.3 Amendment: • Workshops involving training sessions for clinical psychology and IAPT trainees. This amendment is anticipated to result in a number of additional outputs that will maximise the impact of the work and support patient groups at increased risk of inequalities in access to psychological treatments. As per the original MODIFY proposal above, these will include presentations to international conferences, publication in peer-reviewed journals, the integration of findings into training courses and dissemination to patient networks. • Updates via the project website and social media platforms like Twitter. The inclusion of additional patient groups means specific information can be provided to patient networks and charities (e.g., National Autistic Society, Mencap), which will allow further dissemination of findings to individuals, and the opportunity to work with these non-statutory partners to improve the care provided for these groups. Findings related to minoritised ethnicities will be especially relevant to the NHS Race Observatory and will inform part of a programme of work on variations in access and outcome for minoritised ethnic groups in IAPT. As per MODIFY above all data in all outputs will be aggregated with small numbers suppressed as per the HES Analysis Guidance and the IAPT, ECDS and the Mental Health (MHSDS, MHLDDS, MHMDS) data sets Disclosure Policies. • Contributions to reports and roundtables (e.g., Alzheimer’s Society). • Industry newsletters • Briefing documents provided to be integrated into clinical training programs. • Co-hosted events e.g. engagement with NHS policy bodies like the NHS Race Observatory. • Patient-focused journals and newsletters • Dissemination through networks such as the Oxford Academic Health Science Network. • Direct communication with commissioners and clinicians involved in dementia and psychological therapy services. Initial findings have already been shared and published, with ongoing dissemination through journals, conferences, and stakeholder engagement. Further peer-reviewed publications are expected to be produced and submitted throughout the duration of the project, with key outputs likely by late 2025 to early 2026. Training materials and workshops are being integrated into current academic programs, suggesting dissemination is already underway and will continue annually. Policy engagement activities, including contributions to reports and roundtables, are scheduled in alignment with NHS planning cycles, likely continuing through 2025 and into 2026

Expected measurable benefits

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study. To optimise public benefit from the data use in the MODIFY project, UCL has implemented a comprehensive dissemination strategy involving academic publications, conference presentations, and integration into clinical training. Findings will be shared with the public through patient-facing media, social platforms, and collaboration with charities such as the Alzheimer’s Society, Anxiety UK, and the National Autistic Society. Policy engagement is also a priority, with roundtables and contributions to national reports ensuring that insights inform healthcare strategies and improve access to psychological therapies for underserved groups. [1 paragraph unchanged] *********************************************************************** [8 paragraphs unchanged] In the latest approved amendment, UCL had agreement to also look at talking therapies for other key groups, including in neurodivergent people. We have recently UCL has published work based on this: [2 paragraphs unchanged] ****************************************************************** [11 paragraphs unchanged] v1.3 Amendment: It is hoped that through publication of findings in appropriate media, the findings of this research will add to the body of evidence that is considered by the bodies, organisations and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients. The proposed amendment is anticipated to have significant benefits for a wide range of patient groups, who are historically underrepresented in psychological treatment services, and for whom treatment outcomes are understood to be poorer. UCL are proposing re-purposing The MODIFY dataset in particular it is the only dataset UCL know of that allows the identification of Neurodivergence, intellectual disability and physical health comorbidities of people attending IAPT. Consequently, it is the only dataset that UCL are aware of, in which this important, NHS long term plan aligned work would be possible. [2 paragraphs unchanged]

Unchanged: Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + HES-ID to MPS-ID HES Accident and Emergency; + HES-ID to MPS-ID HES Admitted Patient Care; + HES-ID to MPS-ID HES Outpatients

Objective for processing

On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. [3 paragraphs unchanged] UCL are requesting to repurpose the current agreement and build on UCL’s [67 words unchanged] a policy focus on reducing inequalities in psychological therapy access and outcomes. Specifically, UCL will extend the focus to These groups include: people with neurodevelopmental disorders (e.g., autism/ADHD) and intellectual disabilities, people with long-term physical healthcare conditions (e.g., (e.g cardiovascular disease, diabetes, respiratory conditions, multimorbidity) and people from minoritised ethnic groups. [26 words unchanged] around reducing inequalities in their access to and outcomes from health services. [4 paragraphs unchanged] The lawful basis for the MODIFY project is a ‘public task’ which [14 words unchanged] the UK Information Commissioner’s Office (ICO), and for both UCL and NHS Digital, England, and associated partners. The processing of the requested data is necessary to [8 words unchanged] have taken measures to minimise the data requested to remove potential identifiers. [1 paragraph unchanged] • Only periods necessary for analysis have been requested (from the start of IAPT data 2012 to the end of study 2022). latest available). [5 paragraphs unchanged]

Processing activities

NHS Digital England will link Civil Registration Deaths, HES Admitted Patient Care, Outpatients, Accident & [19 words unchanged] Health Learning Disabilities Data Set (all of which are held by NHS Digital) England) using a non-identifiable linking key. Aside from these internal NHS Digital England linkages, there will be no other linkages of this data. The entire linked dataset will be pseudonymised and no identifiable variables have been included in the dataset. The data flow out of is NHS Digital England Civil Reg Deaths, HES APC, OP, A&E, ECDS, IAPT, MHSDS, MHMDS, and [24 words unchanged] out of UCL. There will be no flow of data into NHS Digital. England. [1 paragraph unchanged] The data will be held in the UCL data safe haven using [16 words unchanged] information that is highly confidential. It meets the requirements of the NHS Digital England Information Governance Toolkit and ISO 27001 Information Security standard. Access is controlled [6 words unchanged] they complete training in confidentiality and data protection, which is renewed annually. [1 paragraph unchanged] No organisations other than UCL are involved in the planned data analysis. All those involved in the processing of the data are substantive employees of UCL, or enrolled students on of UCL MSc and doctorate courses and an individual working under honorary contract with UCL under the supervision of UCL substantive employees, and must sign and adhere to an Honorary Contract - for which extra wording covering the responsibility for students has been added. The work undertaken employees. Work under by the students research team is only for the purpose stated in this Agreement. [1 paragraph unchanged] All UCL individuals/UCL students are expected to undertake annual training on handling highly confidential information. All Trainees and students register for and complete NHS Digital’s England’s Data Security Awareness (NHSD) course provided by e-Learning for Health. The course [48 words unchanged] Policy. Trainees'/students' up-to-date training is recorded in the SLMS IG training register. All students working on the MODIFY project are students from UCL. All students working on the MODIFY project will undertake the NHS Digital’s England’s Data Security Awareness course provided by e-Learning for Health. UCL has a [38 words unchanged] face potential sanctions in the event of a breach of the policy. [3 paragraphs unchanged]

Expected measurable benefits

Summary of outputs and benefits achieved to date as provided on the annual confirmation report *31/05/2024 *********************************************************************** Outputs and benefits are all in line with the existing DSA. As expected, UCL produced several peer-reviewed publications about talking therapies and future dementia incidence: John, A., Saunders, R., Desai, R., Bell, G., Fearn, C., Buckman, J. E., ... & Stott, J. (2023). Associations between psychological therapy outcomes for depression and incidence of dementia. Psychological Medicine, 53(11), 4869-4879. Stott, J., Saunders, R., Desai, R., Bell, G., Fearn, C., Buckman, J. E., ... & John, A. (2023). Associations between psychological intervention for anxiety disorders and risk of dementia: a prospective cohort study using national health-care records data in England. The Lancet Healthy Longevity, 4(1), e12-e22. UCL also provided evidence about effectiveness of NHS talking therapies for people living with dementia: Bell, G., El Baou, C., Saunders, R., Buckman, J. E., Charlesworth, G., Richards, M., ... & Stott, J. (2022). Effectiveness of primary care psychological therapy services for the treatment of depression and anxiety in people living with dementia: Evidence from national healthcare records in England. EClinicalMedicine, 52. Bell, G., El Baou, C., Saunders, R., Buckman, J. E., Charlesworth, G., Richards, M., ... & Stott, J. (2024). Predictors of primary care psychological therapy outcomes for depression and anxiety in people living with dementia: evidence from national healthcare records in England. The British Journal of Psychiatry, 1-8. UCL have communicated these findings with local IAPT services and discussed the potential implications to clinical teams. UCL also had discussions with commissioners about these findings and their potential implications for commissioning (e.g. whilst older adults are under-represented in IAPT services, there are new initiatives to increase access for this group, and a better understanding of the importance of effective treatment for common mental health disorders in reducing dementia risk is anticipated to support clinicians working with older age groups). UCL have also had significant interest from our policy partners about this work. UCL applied for and obtained funding (Policy Engagement and Impact fellowship) to organise a policy event based on this work. UCL worked together with policy officers at the Alzheimer’s Society to organise and run this event. Participants included NHS England, IAPT service leads, commissioners, Alzheimer’s Society policy officers, and people living with dementia. Based on this work UCL have also contributed to the Alzheimer’s Society report on post-diagnostic support and services for people living with dementia. In the latest approved amendment, UCL had agreement to also look at talking therapies for other key groups, including in neurodivergent people. We have recently published work based on this: El Baou, C., Bell, G., Saunders, R., Buckman, J. E., Mandy, W., Dagnan, D., ... & Stott, J. (2023). Effectiveness of primary care psychological therapy services for treating depression and anxiety in autistic adults in England: a retrospective, matched, observational cohort study of national health-care records. The Lancet Psychiatry, 10(12), 944-954. This work has led to funding applications for further work on this topic, as well as national talks to commissioners of IAPT services in England. Other related publications are expected in the coming months. ****************************************************************** [16 paragraphs unchanged]

Unchanged: Expected output, Benefits reported.

Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.

Datasets: + Improving Access to Psychological Therapies (IAPT) v2 · − HES-ID to MPS-ID HES Accident and Emergency; − HES-ID to MPS-ID HES Admitted Patient Care; − HES-ID to MPS-ID HES Outpatients; − HES:Civil Registration (Deaths) bridge

Objective for processing

The MODIFY project, otherwise know as “Mental health and other psychological therapy Outcomes; their relationship to Dementia Incidence in the Following Years”, is funded by the Alzheimer's Society and led by University College London researchers. MODIFY aims to enhance understanding of dementia prevention in the UK by examining the role of psychological therapies offered within the England-wide Improving Access to Psychological Therapies (IAPT) services in dementia prevention. On 1 February 2023, NHS Digital merged with NHS England. NHS England has assumed responsibility for all activities previously undertaken by NHS Digital. The merger was completed by a statute change. Any reference made to NHS Digital within this Data Sharing Agreement is in reference to the merged organisation known as NHS England. 35% of dementia cases are thought to be attributable to modifiable risk factors. Many of these dementia risk factors such as anxiety, depression, social isolation or alcohol use may be modifiable through psychological therapy. Despite this, no one has yet tested whether psychological therapies are associated with reduced future risk of dementia. Consequently, the overarching purpose of this request is to understand whether and how IAPT psychological therapies might play a role in preventing dementia and help those already living with the condition as well as elucidating which factors might affect their utility in doing so. The MODIFY project, otherwise known as “Mental health and other psychological therapy Outcomes; their relationship to Dementia Incidence in the Following Years”, is funded by the Alzheimer's Society* and led by University College London (UCL) researchers. UCL are the (sole) Data Controller for this study who also processes the data. MODIFY aims to enhance understanding of dementia prevention in the UK by examining the role of psychological therapies offered within the England-wide Improving Access to Psychological Therapies (IAPT) services in dementia prevention. The researchers plan to create a data resource that links from the ‘NHS Increasing Access to Psychological Therapies’ (IAPT) services to electronic medical records of dementia diagnosis. Using this resource, the researchers will be able to find out whether receiving successful treatment for anxiety and depression is associated with reduced risk of developing dementia. The Applicant has confirmed that this resource and the data within it will not be used for any other studies other than as described in this data sharing agreement. *Originally, this study aimed to only look at dementia incidences and thus obtained funding by the Alzheimer's Society. The study has now expanded its scope to cover other mental health conditions (described below). This additional scope is funded by UCL and not by the Alzheimer's Society. UCL have discussed this expansion with the Alzheimer's Society who have expressed their awareness and are happy with this extension. For clearness, the Alzheimer's Society funding does not scope beyond dementia. The researchers will also look into the possibility of measuring change due to other risk factors not treated in IAPT interventions, such as poor sleep, loneliness, isolation, physical inactivity and high alcohol use. If this is possible, it could lead to a further research into whether psychological therapy may help to prevent dementia by changing other risk factors of dementia. 35% of dementia cases are thought to be attributable to modifiable risk factors. Many of these dementia risk factors such as anxiety, depression, social isolation or alcohol use may be modifiable through psychological therapy. Despite this, no one has yet tested whether psychological therapies are associated with reduced future risk of dementia. Consequently, the overarching purpose of this study is to understand whether and how IAPT psychological therapies might play a role in preventing dementia and helping those already living with the condition and elucidating which factors might affect their utility in doing so. This request for NHS Digital data comprises one component of the MODIFY project which will commence in November 2019. The MODIFY project also includes a feasibility study examining the impact of psychological therapies on dementia relevant outcomes that are not recorded in the national IAPT dataset. This second component will start approximately in March 2020 and will involve prospectively collecting data from several London based IAPT services. This will be subject to a separate IRAS application and it will not involve any data from NHS Digital. UCL are requesting to repurpose the current agreement and build on UCL’s findings from the MODIFY project to further explore inequalities in access to, and outcomes from, IAPT services. MODIFY is specifically focused on both how IAPT treatment reduces the risk of later dementia incidence and whether there are inequalities in access and differential outcomes for individuals with dementia referred to IAPT. In this repurposing addition, UCL propose to extend this to further groups of patients where there is a policy focus on reducing inequalities in psychological therapy access and outcomes. Specifically, UCL will extend the focus to people with neurodevelopmental disorders (e.g., autism/ADHD) and intellectual disabilities, people with long-term physical healthcare conditions (e.g., cardiovascular disease, diabetes, respiratory conditions, multimorbidity) and people from minoritised ethnic groups. This repurposing of the MODIFY dataset to understand outcomes and access issues for these groups will be very helpful in meeting NHS long term plan objectives around reducing inequalities in their access to and outcomes from health services. Young-onset dementia is typically defined as emerging from age 30 onwards, therefore the MODIFY project would like to capture this often ignored group of people with early onset dementia in their data analysis. The cohort consists of anyone with an IAPT record including, but not limited to, those with a linked record in the other datasets. DATA REQUESTED UCL confirm that this resource and the data within it will not be used for any other studies other than as described in this data-sharing agreement. UCL have ensured there is no other way of answering these research questions, especially the linkage needed between healthcare records. The study requires data for adults 20 years and upwards from the start of the study (2012) up to study end in 2022 and referred to IAPT, and their linked Hospital Episode Statistics (HES), Mental Health records and Mortality records as described in data products section of the application. Annual pseudonymised data for IAPT data set and linked records in MHMDS (01 April 2013 – 31 August 2014), MHLDDS (01 Sept 2014 – 30 Nov 2015) or MHSDS (1 Jan 2016 to present (v4 from 1 April 2019) and Mortality data, and HES APC, OP and AE, and ECDS data sets covering the periods 2012-13 to 2021-22. UCL will also look into the possibility of measuring change due to other risk factors not treated in IAPT interventions, such as poor sleep, loneliness, isolation, physical inactivity and high alcohol use. If this is possible, it could lead to further research into whether psychological therapy may help to prevent dementia by changing other risk factors of dementia. The proposed dissemination will create a unique longitudinal linked data set, the analysis of which will provide new information on how psychological therapies in general, and IAPT services in particular, might help prevent dementia. It will, for the first time, enable quantification of: Young-onset dementia is typically defined as emerging from age 30 onwards, therefore the MODIFY project would like to capture this often ignored group of people with early-onset dementia in data analysis. i) the potential longitudinal impact of IAPT interventions on dementia risk and dementia risk factors, The lawful basis for the MODIFY project is a ‘public task’ which sits within UCL’s research core principles as a public authority per guidance issued by the UK Information Commissioner’s Office (ICO), and for both UCL and NHS Digital, and associated partners. The processing of the requested data is necessary to achieve the objectives of the MODIFY project, and have taken measures to minimise the data requested to remove potential identifiers. ii) how that impact might be achieved, Data Minimisation: iii) what elements of IAPT provision might maximise that impact and • Only periods necessary for analysis have been requested (from the start of IAPT data 2012 to the end of study 2022). iv) inequalities in access to IAPT as a potential dementia prevention resource. • Identifiable data is not required. The processing of the data is being carried out under article 6(1)e and 9(2)j of the 2018 Data Protection Act. The proposal meets the requirements of article 6(1)e (public interest), because the outputs will provide the first data on the potential utility of an England wide NHS service (IAPT psychological therapies) in addressing a key public health issue - the prevention of dementia and reduction of chronic disease burden. • Only fields necessary for analyses of the prevention of dementia or amelioration of its co-morbidities or impacts on health and service use (e.g. the entire maternity category is omitted) have been included The proposal meets the requirements of article 9(2)j as it relates to scientific research (described in more detail below) conducted in order to provide the public interest outcome listed above. It is of note, that the scientific research conducted based on this dissemination will also substantially enhance knowledge about dementia prevention globally, since this is the first study to directly examine how psychological therapies for anxiety and depression might prevent dementia. • Only those with an IAPT record (no additional data in HES/MHDS) have been requested. Whilst the study of dementia could be minimised to those over the age of 18 (to account for early on-set dementia), the justification for having no age restriction for the study as a whole is because some of the conditions studied under the expanded purpose (e.g., Neurodevelopmental conditions and intellectual disabilities) have age of onset at birth or early childhood. Therefore including all ages is necessary to ensure UCL are examining outcomes for all individuals with these conditions and in making UCL’s sample as representative of the population as possible. Further, UCL know from the work that younger people do worse than older people in IAPT (Saunders et al., 2021) and also that young people not in education, employment or training (a category that many young people with intellectual disabilities and neurodevelopmental conditions would fall into) have particularly poor outcomes (Buckman et al., 2021). Consequently, not including this group would likely mean that UCL’s estimates of IAPT outcomes would be biased (because people with less positive outcomes would not be included in the sample). It would also mean that UCL might not capture important health inequalities because UCL would not be including the people who are most likely to have poor outcomes in IAPT. In summary, removing the age filter will ensure a) UCL’s sample is as representative are possible; b) estimates are biased to the smallest extent possible, and c) that UCL’s work will captures potential age-related health inequalities. This will make UCL’s work much more useful and relevant in informing healthcare service provision and thus is critical in providing greatest benefit to patients, the public and healthcare systems.

Processing activities

NHS Digital will link the datasets listed in products Civil Registration Deaths, HES Admitted Patient Care, Outpatients, Accident & Emergency, Emergency Care Data Set, IAPT, Mental Health Services Data Set, Mental Health Maternity Services Data Set and Mental Health Learning Disabilities Data Set (all of which are held by NHS Digital) using a non-identifiable linking key. Aside from these internal NHS Digital linkages linkages, there will be no other linkages of this data. The entire linked dataset will be pseudonymised and no identifiable variables have been included in the dataset. The data flow out of is NHS Digital would be the data sets described in products Civil Reg Deaths, HES APC, OP, A&E, ECDS, IAPT, MHSDS, MHMDS, and above, MHLDDS, which would include includes special categories of pseudonymised health data going to the data safe haven [10 words unchanged] of UCL. There will be no flow of data into NHS Digital. [1 paragraph unchanged] The data will be held on in the UCL data safe haven using UCL approved computers. The Data Safe [41 words unchanged] they complete training in confidentiality and data protection, which is renewed annually. [1 paragraph unchanged] No organisations other than UCL are involved in the planned data analysis. [19 words unchanged] and doctorate courses under the supervision of UCL substantive employees, and must a sign and adhere to an Honorary Contract - for which extra wording [10 words unchanged] undertaken by the students is only for the purpose stated in this Purpose section. Agreement. No elements of the work will take place outside the UK. England and Wales. All UCL students are expected to undertake annual training on handling highly [61 words unchanged] the School of Life and Medical Sciences (SLMS) Information Governance Training Policy. Trainees'/ students Trainees'/students' up-to-date training is recorded in the SLMS IG training register. All students working on the MODIFY project are students from UCL. All [47 words unchanged] students working on the MODIFY project are bound by this policy, and that they will face potential sanctions in the event of a breach of the policy. All students sign up to for the UCL's Academic Manual. The Student Academic Misconduct section of the 2019-2020 [25 words unchanged] UCL’s Procedure for Investigating and Resolving Allegations of Misconduct in Academic Research". DATA MINIMISATION • The study requires data for adults aged 20 and above from 2012 (study baseline). There is no upper age limit. Only data is required where an individual also has a record in IAPT data. • Only periods necessary for analysis have been requested (from the start of IAPT data 2012 to end of study 2022). • Identifiable data is not required. • Only fields necessary for analyses of the prevention of dementia or amelioration of its co-morbidities or impacts on health and service use (e.g. the entire maternity category is omitted) have been included. OUTPUTS [1 paragraph unchanged] The analyses used following the expansion of the purpose (extending the study to further groups of patients were there is a policy focus on reducing inequalities in psychological therapy access and outcomes) is of the same type as those proposed for the original MODIFY analysis protocol.

Expected output

The Under the previous iteration the outputs will include included progress reports to Alzheimer's Society, which will be were annual with the first report due in July 2020 and 2020, the next in 2021, with and the final one in July 2022. These were submitted to the Alzheimer’s Society as planned. This report is intended for internal use only and is not published externally. It is expected that several empirical papers will continue to be submitted to key relevant peer reviewed peer-reviewed journals such as the Lancet Psychiatry, the British Journal of Psychiatry, Alzheimer’s and Dementia and the International Journal of Geriatric Psychiatry. The first of these is expected to be were submitted around the end of year 1 of the grant (July 2020) 2020 - https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2930367-6) with other publications submitted (or to be submitted) in the three years following that. There will be conference presentations including presentations at the annual Alzheimer’s Society conference (May/June of July 2020, 2021, 2022) and a planned presentation at the world’s largest international dementia conference the Alzheimer’s Association International Congress (AAIC) in July 2021 and 2022. UCL presented this work to the Alzheimer’s Society Network group and also presented the work in a presentation to the Oxford Academic Health Science Network in July 2022. OUTPUTS [1 paragraph unchanged] There will be an active process of dissemination of the project to relevant stakeholders as the projects project goes on. This will be done through ongoing engagement with the project [24 words unchanged] that include clinicians, people affected by dementia, depression and anxiety, researchers and policy makers. policymakers. Summaries of outputs will be published in patient facing patient-facing journals. The Alzheimer’s Society will publish results in their ‘care and cure’ magazine. The project also has links with AnxietyUK who would which will publish results in their newsletter. There will also be direct bilateral engagement [25 words unchanged] presentations will be disseminated through UCL media channels (including collaborator and departmental twitter Twitter accounts). Workshops based on findings will be run with the 150 clinical psychology trainees on the UCL clinical psychology doctorate of which the applicant is the Clinical Director. Findings will also be integrated into the IAPT training courses [91 words unchanged] also facilitate the development of new relationships which will be used to further disseminate findings. findings further. There will be active communication to ensure findings reach their intended audience. This will be through many of the dissemination activities and channels listed above but also and through a project website (still in production) (https://www.adaptlab.net/modify) and promotion of research at conferences with large degrees of lay attendance [42 words unchanged] group and other partners above as to how best to communicate findings. [1 paragraph unchanged] v1.3 Amendment: This amendment is anticipated to result in a number of additional outputs that will maximise the impact of the work and support patient groups at increased risk of inequalities in access to psychological treatments. As per the original MODIFY proposal above, these will include presentations to international conferences, publication in peer-reviewed journals, the integration of findings into training courses and dissemination to patient networks. The inclusion of additional patient groups means specific information can be provided to patient networks and charities (e.g., National Autistic Society, Mencap), which will allow further dissemination of findings to individuals, and the opportunity to work with these non-statutory partners to improve the care provided for these groups. Findings related to minoritised ethnicities will be especially relevant to the NHS Race Observatory and will inform part of a programme of work on variations in access and outcome for minoritised ethnic groups in IAPT. As per MODIFY above all data in all outputs will be aggregated with small numbers suppressed as per the HES Analysis Guidance and the IAPT, ECDS and the Mental Health (MHSDS, MHLDDS, MHMDS) data sets Disclosure Policies.

Expected measurable benefits

[1 paragraph unchanged] There are between 850,000 – 1,000,000 people with dementia in the UK and a recent Lancet commission report (https://www.thelancet.com/action/showPdf?pii=S0140-6736%2820%2930367-6) estimated that 35% of dementia risk is explained by modifiable risk factors. [62 words unchanged] costs that dementia brings, this reduction in incidence would be of significant import importance to population wellbeing and healthcare budgets. Through quantifying and understanding the potential [6 words unchanged] reduction, appropriate information can be provided to the 500,000 IAPT attendees yearly. [6 paragraphs unchanged] ii) Clinical practice ( Trust leads for IAPT in London based NHS trusts, integration into the training of 150 clinical psychologists and 200 IAPT trainees at UCL, presentations and workshops to clinical audiences) iii) IAPT service user and dementia movements (Grant co investigators co-investigators and collaborators include 5 members of the Alzheimer’s Society volunteer research network all of whom are affected by of dementia as well as IAPT service users who are active in promoting IAPT service user interests) [1 paragraph unchanged] v1.3 Amendment: The proposed amendment is anticipated to have significant benefits for a wide range of patient groups, who are historically underrepresented in psychological treatment services, and for whom treatment outcomes are understood to be poorer. UCL are proposing re-purposing The MODIFY dataset in particular it is the only dataset UCL know of that allows the identification of Neurodivergence, intellectual disability and physical health comorbidities of people attending IAPT. Consequently, it is the only dataset that UCL are aware of, in which this important, NHS long term plan aligned work would be possible. The proposed analyses will identify groups of individuals who are at risk of poor access to and outcomes from IAPT treatment. It will also test the specific factors (such as specific interventions or the method by which people access treatments) which may improve both access and outcomes for these groups, thus facilitating evidence-based strategies to reduce inequalities for them. In addition, it will allow granular investigation of the role of patient characteristics such as age, nature of the physical or mental health disorder, and ethnicity, which may intersect with the presence of neurodevelopmental or physical comorbidities in affecting both access and outcomes. Consequently, the planned re-purposing will allow UCL to determine not only which groups are at risk of poor access and outcomes, but who within those groups are particularly at risk, and why. UCL anticipate that these understandings will form the basis of guidance, strategies, resources and training for referrers and IAPT staff to enhance access and adapt therapy to better cater for neurodivergent individuals, those with an intellectual disability and minority ethnic groups, all of whom are likely to be under-served by current service provision. As such UCL’s work would support a key aim of the NHS long term plan in helping to reduce healthcare inequalities experienced by these groups. The impact, implementation and dissemination of UCL’s findings will be supported by UCL’s position at a world-leading university (UCL) in the department which trains the largest number of psychological therapists of any UK university department (clinical educational and health psychology) as well as UCL’s extensive networks of people with lived experience, clinicians, service and national IAPT leads, senior academics and commissioners.

Benefits reported

Yielded Benefits is not a requirement for new applications. UCL’s current findings show a significant association between psychological therapy outcomes (IAPT) and future dementia incidence (identified in HES and MHDS records). From an academic perspective, these findings have been written up for publication and UCL’s first paper has been reviewed and it is hoped it will obtain formal acceptance in the coming months. More importantly, UCL have communicated these findings with local IAPT services and discussed the potential implications to clinical teams. UCL are also in active discussions with commissioners about these findings and their potential impacts for commissioning (e.g. whilst older adults are under-represented in IAPT services, there are new initiatives to increase access for this group, and a better understanding of the importance of effective treatment for common mental health disorders in reducing dementia risk is anticipated to support clinicians working with older age groups). UCL have also had significant interest from UCL’s policy partners in this work. UCL have secured funding (Policy Engagement and Impact fellowship) to organise a policy event based on this work. UCL are actively working together with Policy officers at the Alzheimer’s Society. Based on this work UCL have also contributed to their upcoming report on post-diagnostic support and services for people living with dementia. UCL are working with the Alzheimer’s Society to organise a policy roundtable event to discuss with a range of stakeholders (people living with dementia, commissioners, clinicians, policy professionals, and researchers) about how findings from this work can be translated into IAPT, including strategies to improve access for people living with dementia and older people more generally. UCL have also been invited to co-host a webinar with the Alzheimer’s Society and NHS England on the topic of increasing access to IAPT for people living with dementia. This will be to an audience of clinicians and commissioners. UCL also presented this work to the Oxford Academic Health Science Network (a group of IAPT clinicians, psychiatrists, nurses, and commissioners).