ACT for Functional Cognitive Disorders – feasibility study
Award Number
NIHR202743Programme
Research for Patient BenefitStatus / Stage
ActiveDates
5 February 2022 -5 January 2024
Duration (calculated)
01 years 11 monthsFunder(s)
NIHRFunding Amount
£244,464.00Funder/Grant study page
NIHRContracted Centre
South West London and St George's Mental Health NHS TrustPrincipal Investigator
Dr Norman PoolePI Contact
npoole@forensicpsychiatrychambers.comPI ORCID
0000-0002-3187-6430Principal Investigator
Professor Mark EdwardsPI Contact
mark.edwards@stgeorges.nhs.ukPI ORCID
0000-0002-8283-9015WHO Catergories
Improving clinical trialsDisease Type
Functional Cognitive Disorder (FCD)CPEC Review Info
| Reference ID | 9 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Award Number | NIHR202743 |
|---|---|
| Status / Stage | Active |
| Start Date | 20220205 |
| End Date | 20240105 |
| Duration (calculated) | 01 years 11 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | South West London and St George's Mental Health NHS Trust |
| Funding Amount | £244,464.00 |
Abstract
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.
Aims
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.