Introduction
The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.
Research question
What is the clinical and cost-effectiveness of antipsychotics for treating symptoms of borderline personality disorder?
- Intervention: A second generation antipsychotic in addition to usual care. Applicants to define and justify specific antipsychotic(s), dose and regimen.
- Patient group: Adults diagnosed with borderline personality disorder who are not currently taking mood stabilising or antipsychotic medication. Exact criteria should be defined and justified by applicants. Consideration should be given to comorbid mental health disorders and any psychological treatments being received.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Setting: Any appropriate setting. Applicants to define and justify.
- Control: An appropriate placebo(s) or comparator(s) plus usual care.
- Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial. Applicants should consider innovative designs that could allow the inclusion of more than one intervention to be tested.
- Important outcomes: Symptoms of borderline personality disorder; quality of life.
- Other outcomes:Patient acceptability; occupational/educational outcomes; social functioning; impact on relationships; other mental health outcomes; self-harm/suicidal behaviours; side effects; adverse effects; metabolic outcomes; health service utilisation, cost-effectiveness. Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
- Minimum duration of follow-up: 1 year.
- Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Borderline personality disorder (BPD) is described in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) as ‘A pervasive pattern of instability of interpersonal relationships, self-image and affects, and marked by impulsivity beginning by early adulthood’. A 2014 survey of the mental health and wellbeing of 7500 adults in England, found that 2.4% of those aged between 16-64 years old screened positive for BPD. In clinical psychiatric populations, the prevalence of BPD is high; it is estimated to be 10% for outpatients and between 15-25% for inpatients. People with BPD are often frequent users of general primary care.
Each person’s experience of BPD is unique, but it can adversely affect all aspects of someone’s life including their relationships and social and occupational/educational functioning. People with BPD have higher rates of mortality and shorter life expectancy compared to the general population.
Current NICE guidelines recommend considering psychological therapy for people with BPD, an example of which is Dialectal Behavioural Therapy (DBT). Therapies such as DBT are long-term interventions and challenges such as limited availability, inequity of access and long waiting times have been identified. In addition, some people with BPD are unable, or prefer not, to engage in therapy or drop out before treatment is complete. There are currently no other treatment options recommended for people with BPD.
NICE state that while comorbid mental health problems should be treated, medication is not recommended for the treatment of the symptoms of BPD as there is insufficient evidence. However, potentially in part because of the challenges previously mentioned with accessing psychological therapies, as well as clinicians endeavouring to help people with often high levels of distress, the use of medication to treat the symptoms of BPD in UK clinical practice is common.
A recent review found that there is a ‘manifest gap between evidence and practice’ and called for more research into the most commonly used medications.
The prescribing of antipsychotics for people with BPD is widespread; however, currently a decision made by a clinician and patient about whether to use medication is based on scant evidence. The HTA Programme is interested in commissioning research in this area to address this gap between evidence and practice.
Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (or their advocates) in order to provide evidence and actionable findings of immediate utility to decision-makers and service users. Applicants may wish to consult the NIHR Learning for Involvement guidance on co-producing research.
Additional commissioning brief background information
A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.
Making an application
If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.
Your application must be submitted online no later than 1pm on the 27 July 2022. Applications will be considered by the HTA Funding Committee at its meeting in September 2022.
Guidance notes and supporting information for HTA Programme applications are available.
Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in January 2023.
Applications received electronically after 1300 hours on the due date will not be considered.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk.