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 a NICE-recommended high intensity cognitive-behavioural therapy (CBT) protocol which has been adapted for autistic adults compared to the un-adapted equivalent?
Applicants to select and justify the specific NICE-recommended CBT protocol to be adapted; it must currently be delivered in NHS Talking Therapies services.
- Patient group: Autistic adults with symptoms of the specific anxiety disorder or depressive disorder (as selected and justified by applicants). Consideration should be given to any current or previous treatments for the specific disorder. Applicants to define and justify exact criteria in relation to chosen CBT therapy protocol.
Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field. - Intervention: A NICE-recommended high intensity cognitive-behavioural therapy (CBT) protocol for a specific anxiety disorder or depressive disorder (as delivered in NHS Talking Therapies services) adapted for autistic people for individual delivery face-to-face and remotely by video.
Applicants should:
- Define and justify the specific anxiety disorder or depressive disorder protocol that they will adapt.
- Define and justify the adaptations that will be made to the protocol for face-to-face delivery and for remote delivery by video.
- Detail how high intensity therapists (or equivalent) will be trained to deliver the adapted protocol. - Comparator: The un-adapted version of the NICE-recommended CBT disorder-specific protocol selected by applicants. CBT takes a collaborative approach, which is flexible and responsive to the individual’s needs.
Applicants should ensure that the high intensity practitioners (or equivalent) delivering the intervention in both arms, receive the same (a) autism awareness training and (b) the same frequency and duration of supervision in which to discuss individuals and their personalised goals. - Important outcomes: Change in symptoms (as measured by a validated scale); Cost effectiveness.
Other outcomes: Quality of life; self-harm; occupational/educational functioning; acceptability to people receiving the intervention; acceptability to therapists delivering the intervention; adherence; adverse effects; use of other services.
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). - Setting: NHS Talking Therapies services.
- Study design:
- An efficient and focused development phase to adapt a current NICE-recommended CBT treatment protocol (currently delivered in NHS Talking Therapies services) so that it is accessible and acceptable for autistic adults. Applicants should clearly define and justify the adaptations to the protocol and appropriate success criteria for judging adaptation of the protocol to warrant a full evaluation.
- A randomised controlled trial with an internal pilot phase to assess key trial processes such as recruitment, acceptability of the intervention to all parties, and uptake and adherence by people receiving the intervention.
- Applicants should give consideration to the Medical Research Council’s framework on the development and evaluation of complex interventions (aplicants should specify how the proposed approach aligns with this framework.
- Applicants should also consider issues of adherence to the intervention throughout all stages of the study, including therapist training and supervision. Co-production, which ensures that - the research demonstrates an equal partnership with service commissioners, providers and service users (or their advocates), should be embedded throughout the life cycle of the project from application to completion. Applicants may wish to consult the NIHR Learning for Involvement guidance on co-producing research.
- Clear stop/go criteria should be provided to inform progression between the development stage, the internal pilot stage, and the full trial. - Minimum duration of follow-up: 1 year.
Longer-term follow up: If appropriate, researchers should consider obtaining consent to allow potential future follow-up through efficient means (such as routine data) as part of a separately funded study.
Rationale
Autism is a lifelong developmental condition that impacts on how a person interacts with other people and how they experience the world. Traits are typically apparent from early childhood, though may not become fully evident until later. Approximately 1-2% of the population in England is autistic. Mental health conditions are more prevalent in the autistic population than in the general population.
Currently the NHS Talking Therapies services deliver NICE-recommended evidence based psychological therapies for adults with depression and anxiety disorders. There are several different high-intensity therapeutic modalities offered, but cognitive-behavioural therapy (CBT) is by far the most frequently used. Each mental health disorder (referred to by NHS Talking Therapies services as the problem descriptor) will have a specific evidence-based NICE-recommended CBT protocol. High intensity individual CBT treatment is delivered by High Intensity Practitioners (or the equivalent) either face-to-face or remotely via video.
For autistic adults accessing NHS Talking Therapies services, NICE guidance states that psychosocial interventions offered should be informed by existing NICE guidance for the specific disorder with adaptations. The types of adaptations suggested include taking a more concrete and structured approach, with a greater use of written and visual material while placing more emphasis on behavioural (rather than cognitive) approaches. However, currently these types of adaptations are not integrated into the protocols to be used in a consistent way across services.
A 2022 review of qualitative studies found that autistic adults’ experience of accessing and receiving mental health support was predominantly negative. A recent systematic review and meta-analysis found that although CBT may decrease anxiety and depression scores in autistic adults, there is insufficient evidence upon which to draw any firm conclusions. An observational study of national healthcare records looked at therapy outcomes for autistic adults in primary care services compared with a matched cohort of non-autistic adults, and found that outcomes for the autistic group were poorer. Depression and anxiety scores were significantly less likely to improve, and were significantly more likely to deteriorate despite the autistic group receiving more high-intensity treatment sessions.
The need for more research into how mental health interventions can be adapted for the needs of autistic people has been highlighted by both the James Lind Alliance Priority Setting Partnership in Autism, and by NHS England through the Research demand signalling National Learning Disability and Autism Programme, and Five-year NHS autism research strategy for England. The research strategy states that ‘Change is needed to ensure that health policy and clinical decisions about the care provided to autistic people is consistently based on the best available scientific evidence’.
To help address this identified evidence gap, the HTA Programme is interested in commissioning research to evaluate a NICE recommended CBT disorder specific protocol currently being used in NHS Talking Therapies services, that has been adapted for autistic adults for individual delivery face-to-face and remotely by video. It will be for applicants to select and justify the specific mental health condition and associated CBT protocol they will adapt, and define and justify the adaptations they plan to make to the protocol for both face-to-face and remote delivery.
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 would like to apply for this call, you can begin your application via the funding call page.
Your application must be submitted online no later than 1pm on 27 November 2024. Applications will be considered by the HTA Funding Committee at its meeting in January 2025.
Guidance notes and supporting information for HTA Programme applications are available.
Shortlisted Stage 1 applicants will be given 8 weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2025.
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team, other than in unusual circumstances (for example, a lead from a named charity or a unique national expert in a condition).
For such exceptions, each application needs to state the case as to why the same person is included. The shared co-applicant should not divulge application details between teams, and both teams should acknowledge in their application that they are aware of the situation, and that study details have not been shared.
Should you have any queries please email, htacommissioning@nihr.ac.uk.