Title: ACT for Functional Cognitive Disorders - feasibility study
Funder: Department of Health and Social Care

Abstract: Background Those with Functional Cognitive Disorder present with clinically significant cognitive complaints in the absence of relevant neuropathology. As Diagnostic Memory and Cognitive Neurology Clinics (DMCs and CNCs respectively) became widespread, an increasing number of people with FCD are being identified. However, the majority are discharged without treatment and no established standards of care exist. The Neuropsychiatry Service at St George's Hospital in South West London has developed a potential treatment for FCD. This is a brief (10 hours) group Acceptance and Commitment Therapy (ACT) intervention delivered over 5 sessions. It aims to reduce distress associated with cognitive symptoms and to improve day-to-day functioning. This study aims to investigate whether a randomised control trial of ACT versus treatment as usual is feasible. During the trial period we will refine the ACT intervention to improve acceptability and adapt for online delivery. If the intervention proves feasible with promising clinical outcomes, progression to a substantive study could take place. Aims and Objectives Test the acceptability and feasibility of the brief group ACT intervention delivered physically and/or virtually (COVID-19 and participant preference depending) Investigate the value of a range of clinical outcome measures, especially the ACT-specific measure of psychological flexibility Acceptance and Action Questionnaire II (AAQ-II) to determine the sample size for a future definitive RCT. Carry out semi-structured interviews with participants to investigate the lived experience of those with FCD and their experience of the interventions (both treatment as usual and ACT) and clinical outcome measures to enable refinement of the intervention and the design of a future definitive RCT. Methods 48 adult patients with a diagnosis of FCD will be recruited via local DMCs and a tertiary CNC. The study will be a single-blind randomised controlled trial (RCT) with two conditions: brief group ACT and a standardised treatment as usual. The two groups will be compared at baseline (T0), 8 weeks (T1), 16 weeks (T2), and 26 weeks (T3). The feasibility of delivering the trial will be studied, specifically: recruitment, adherence, retention, acceptability, and safety. Clinical outcome measures assess psychological flexibility, self-evaluation of memory function, anxiety, depression, quality of life, service-utilisation and other costs. Feasibility outcomes will be summarised using descriptive statistics. Throughout the intervention and follow-up period, participants will be offered the opportunity to be involved in one-to-one qualitative interviews to explore their experience of living with FCD, the acceptability of the interventions, and the suitability of the clinical outcome measures. Their responses will influence development of future semi-structured interviews and lead to refinement of the intervention to improve acceptance and adherence. Timelines for delivery The trial will take 24 months, including study set-up, recruitment and data collection, data analysis, writing up and submission, followed by development of the ACT treatment protocol for a future RCT. Anticipated Impact and Dissemination Dissemination will occur via established links with patient-led charities (FND Hope and FND Action), conferences, and journal publications. If the trial proves feasible and there is a signal of efficacy we will progress to a definitive multi-centre RCT.

Lay abstract: Functional Cognitive Disorder (FCD) is a relatively new term in neurology and psychiatry. It is used to describe patients who experience real difficulties with their memory yet show no signs of a neurological condition, such as dementia. Brain scans and other investigations do not reveal an abnormality that could account for the symptoms. Diagnostic Memory Clinics (DMCs) were developed to improve the access of people with dementia to diagnosis and support. Over the past decade, increased numbers of people have been seen in these clinics. A significant proportion of those seen, however, are found to have a functional cognitive disorder. Despite the symptoms being disabling and persistent, memory clinic teams are unsure how to help these patients. Instead, they are discharged back to their GP without any support or treatment. The cause of these memory symptoms is not well understood. Most researchers believe that low mood and anxiety contribute to the symptoms but are not the full explanation. It has been proposed that patients with FCD are unusually alert to memory lapses. These lapses in turn increase fear of memory failure and doubts about the accuracy of recalled memories. This sets up a vicious cycle of increased monitoring for memory lapses and a corresponding decrease in the amount of attention available to be directed towards the world. There is some evidence that brief psychological treatments can be beneficial. These involve education about the condition and stress management advice. A recent study that combined outcomes from multiple independent studies showed that this treatment delivered in small groups improved psychological well-being. However, the majority of studies were of low quality. Also, the proposed interventions were lengthy, involving up to 13 one-hour long sessions. The authors concluded that a large-scale research trial is now &quot;urgently needed&quot;. At St George's Hospital, a centre of excellence for functional neurological disorders, we have developed a five-session group treatment. Initial pilot data suggests it improves quality of life and decreases distress. We aim to study the feasibility of delivering this group intervention to patients with FCD within local memory clinics. If it proves feasible, we plan to follow-up with a pilot study to investigate whether the intervention does improve outcomes for these patients. Ultimately, we aim to perform a multi-site trial to assess whether FCD patients can engage and benefit from the intervention in the wider NHS setting. This would allow the many patients across the UK who currently receive no help to benefit from treatment. This study design has benefitted from the involvement of patients with FCD, including from the charity FND Hope, from the start. Their involvement has helped refine the study design and particularly the outcome measures to ensure these are appropriate and acceptable.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH