Mental health treatment requirements
| ISRCTN | ISRCTN12201122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12201122 |
| IRAS number | 339957 |
| Secondary identifying numbers | LSCFT-RD23010, CPMS 64720 |
- Submission date
- 09/08/2024
- Registration date
- 28/10/2024
- Last edited
- 26/11/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Many people who attend court have severe and complex mental health problems. They often find it difficult to access treatment. They can face stigma, homelessness, financial and substance problems. A prison sentence can make these problems worse and does not help their mental health.
A Mental Health Treatment Requirement (MHTR) can be given instead of a short prison sentence by courts in England and Wales if the person agrees. It means that they must attend for treatment of their mental health problem as part of a community sentence. Secondary MHTRs (SC-MHTR) are for people who need specialist mental health care. Until now, courts have ordered very few SC-MHTRs. The NHS has given money to three courts in England, called ‘proof-of-concept’ sites, to investigate whether more people could benefit from SC-MHTRs. They think that this could improve their mental health and reduce the number of people with severe mental health problems going to prison. The NHS would like to see an increase in SC-MHTRs across the country and needs to learn the best way to go about this. There is no research evidence about how to increase use of SC-MHTRs. We also do not know if they affect health, or if they can work for different people and in different places.
This study will examine how people use SC-MHTRs at the proof-of-concept sites and at a Welsh site. The researchers want to know if SC-MHTRs are working, who for, how and why. This will let them tell the NHS the best way to introduce them across the country. They also aim to develop a way to measure their effect on health and on NHS costs across the country in future.
Who can participate?
Adult patients aged 18 years and over who are under an SC-MHTR, carers of patients under an SC-MHTR, commissioners, policymakers and staff involved in the creation and implementation of SC-MHTRs.
What does the study involve?
The researchers will get information in three ways:
1. Review documents about people’s expectations about SC-MHTRs
2. Hold interviews with people who designed the SC-MHTR, staff, patients, and their families
3. Examine NHS records that describe patients on SC-MHTRs and SC-MHTR numbers
They will use this information to:
1. Find out how SC-MHTRs are being delivered
2. Explain how SC-MHTRs work (or do not work) for which patients and in what circumstances
3. Tell the NHS about the best way to increase SC-MHTRs across the country and overcome problems
4. Design a way to evaluate a future national SC-MHTR programme.
What are the possible benefits and risks of participating?
There is no direct benefit to research participants, but participants taking part in interviews/workshops may benefit from being part of the research process and contributing to the evaluation of SC-MHTRs. For example, being able to discuss their experiences and 'be heard' may have a positive effect on participants.
The study involves the discussion of sensitive topics. There will be a safeguarding protocol in place to minimise the risk of participant distress.
Where is the study run from?
Lancashire and South Cumbria NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
February 2024 to July 2026
Who is funding the study?
National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Programme (UK)
Who is the main contact?
Dr Kerry Gutridge (Project Manager), kerry.gutridge@manchester.ac.uk
Contact information
Public, Scientific, Principal Investigator
Division of Psychology and Mental Health
School of Health Sciences
Faculty of Biology, Medicine and Health
University of Manchester
Jean McFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)1772 676134 |
|---|---|
| louise.robinson@manchester.ac.uk |
Public, Scientific
2nd Floor, Jean McFarlane Building, University of Manchester, Oxford Road
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0001-9705-9102 |
|---|---|
| Phone | +44 (0)7784 016 900 |
| kerry.gutridge@manchester.ac.uk |
Study information
| Study design | Scientific realist framework |
|---|---|
| Primary study design | Observational |
| Secondary study design | Scientific realist framework |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | An evaluation of secondary care mental health treatment requirements |
| Study acronym | SC-MHTR |
| Study objectives | To develop a Secondary Care Mental Health Treatment Requirements (SC-MHTR) programme theory that would facilitate understanding of need, barriers to take-up and delivery, and solutions, and form the basis for a full evaluation of SC-MHTRs in anticipation of a national programme rollout across England and Wales. Research questions: 1. How is the SC-MHTR being delivered? 2. What works, for whom at each of the study sites, and what are the mechanisms that underpin this? 3. What can we learn from the sites about improving delivery across different geographic, socio-economic and organisational contexts? 4. How should we evaluate a future national SC-MHTR programme? |
| Ethics approval(s) |
Approved 28/10/2024, Wales REC 4 (Health and Care Research Wales, Castlebridge 5, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0) 2922 941119, 2922 940989; Wales.REC4@wales.nhs.uk), ref: 24/WA/0267 |
| Health condition(s) or problem(s) studied | Secondary care mental health treatment requirements |
| Intervention | The SC-MHTR is a complex intervention that may be offered after conviction in a magistrates’ or Crown court to tailor a community or suspended sentence. It involves assessment by probation and health personnel and explanation to the offender, assessment, agreement between them and, if agreed, a recommendation to the court, sentencing and then the management of the arrangement and delivery of treatment, with return to court if in breach. Thus, the parties come from very different training and professional backgrounds and co-operation must be achieved between them across separately commissioned services. The NIHR/MRC framework for developing and evaluating complex interventions has informed our research approach. A Scientific Realist Framework will be adopted. A realist approach assumes that the same intervention will not work in the same way everywhere and for everyone, and focuses upon ‘what works, for whom, in what way, and how’. The Government recognises the importance of this approach for evaluating interventions at early stages and to understand how to adapt them to new contexts to understand how and why differences occur. Here, the plan fits with a four-step process within two work packages. In Work Package 1, the researchers will: 1. Formulate an initial programme theory by drawing on extant documents and interviewing central policy staff 2. Conduct preliminary testing of this model with NHS routine data and proof of concept and Wales site staff, patients, and carers 3. Consolidate the programme theory In Work Package 2, the researchers will design the large-scale evaluation |
| Intervention type | Other |
| Primary outcome measure | Views and experience of staff, patients and carers on secondary care MHTRs collected from 01/10/2024 to 31/01/2026. Data will be analysed using a realist approach to thematic analysis and descriptive statistics, using realist methods to develop an Initial Programme Theory to describe how secondary MHTRs work, in what way and for whom. |
| Secondary outcome measures | Quantitative analysis of routine health and justice datasets collected from 01/10/2024 to 31/01/2026. Data will be analysed using a realist approach to thematic analysis and descriptive statistics, using realist methods to develop an Initial Programme Theory to describe how secondary MHTRs work, in what way and for whom. |
| Overall study start date | 01/02/2024 |
| Completion date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84 |
| Key inclusion criteria | Patients: 1. Adults aged 18 years or over 2. Capacity to consent to participate in the study 3. Recommended for, under, or recently (within 3 months) under an SC-MHTR Carers: 1. Adults aged 18 years or over 2. Capacity to consent to participate in the study 3. Family member or informal caregiver of someone recommended for, under, or recently (within 3 months) under an SC-MHTR Professionals: 1. Aged 18 years or over 2. Have working knowledge of how SC-MHTRs operate |
| Key exclusion criteria | Patients: 1. Aged 17 years and under 2. Lacking the capacity to provide informed consent to participate 3. Not recommended for, under, or recently (within 3 months) under an SC-MHTR 4. Considered by staff not safe to interview due to their current risk assessment Carers: 1. Aged 17 years and under 2. Lacking the capacity to provide informed consent to participate 3. Not a family member or informal caregiver of someone recommended for, under, or recently (within 3 months) under an SC-MHTR Professionals: 1. Aged 17 years and under 2. Do not have a working knowledge of how SC-MHTRs operate |
| Date of first enrolment | 01/02/2025 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
St Georges Hospital
Corporation Street
Stafford
ST16 3SR
United Kingdom
1010 Pioneer Avenue
Gloucester Business Park
Gloucester
GL3 4AW
United Kingdom
Tonna Uchaf
Tonna
Neath
SA11 3LX
United Kingdom
9 Alie Street
London
E1 8DE
United Kingdom
C E M E Centre
Marsh Way
Rainham
RM13 8GQ
United Kingdom
350 Euston Road
Regents PLACE
London
NW1 3AX
United Kingdom
London
N15 3TH
United Kingdom
4 St Pancras Way
London
NW1 0PE
United Kingdom
Pinewood PLACE
Dartford
DA2 7WG
United Kingdom
London
SW17 0YF
United Kingdom
Southall
UB2 4SD
United Kingdom
Monks Orchard Road
Beckenham
BR3 3BX
United Kingdom
120 Belsize Lane
London
NW3 5BA
United Kingdom
Sponsor information
Hospital/treatment centre
The Lantern Centre
Vicarage Lane
Fulwood
Preston
PR2 8DW
England
United Kingdom
| Phone | +44 (0)1772773498 |
|---|---|
| farah.lunat@lscft.nhs.uk |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Consultation will be carried out with participants, the Patient and Public Involvement and Engagement (PPIE) panel and SSG to inform the final dissemination strategy, including which information to share with which groups, and the best forms of communication to use. However, plans will include written documents (including lay summaries), posters and videos (produced by PPIE co-applicants), posts on the study website, and social media (including X and the Health and Justice Research Network) as well as conference presentations and academic papers. Online dissemination events for participants will be held. Short videos and lay summaries will be disseminated on social media, the project website, the Health and Justice Research Network (HJRN) website, mail and email. A press release will be produced for the media. |
| IPD sharing plan | The datasets generated during and or/analysed during the current study are not expected to the made available due to restrictions included in the data sharing agreements and the specificity of the data. |
Editorial Notes
26/11/2024: A study contact was added.
20/11/2024: The following changes were made:
1. Ethics approval added.
2. The recruitment start date was changed from 01/10/2024 to 01/02/2025.
06/11/2024: Internal review.
09/08/2024: Study's existence confirmed by the NIHR.
