I can’t forget to worry’: A pilot randomised controlled trial of CBT for anxiety in people with dementia.

Award Number
PB-PG-0609-18230
Programme
Research for Patient Benefit
Status / Stage
Completed
Dates
31 October 2010 -
30 April 2013
Duration (calculated)
02 years 05 months
Funder(s)
NIHR
Funding Amount
£199,775.00
Funder/Grant study page
NIHR
Contracted Centre
North East London NHS Foundation Trust
Contracted Centre Webpage
Principal Investigator
Professor Aimee Spector
PI Contact
a.spector@ucl.ac.uk
PI ORCID
0000-0003-4448-8143
WHO Catergories
Development of novel therapies
Disease Type
Dementia (Unspecified)

CPEC Review Info
Reference ID123
ResearcherReside Team
Published12/06/2023

Data

Award NumberPB-PG-0609-18230
Status / StageCompleted
Start Date20101031
End Date20130430
Duration (calculated) 02 years 05 months
Funder/Grant study pageNIHR
Contracted CentreNorth East London NHS Foundation Trust
Contracted Centre Webpage
Funding Amount£199,775.00

Abstract

Many people with dementia experience anxiety that can cause or exacerbate problems including decreased cognitive function, high physical dependency, relationship difficulties, behavioural problems and increased admittance to care homes. Nonetheless, there is a paucity of research and lack of understanding of psychological approaches to anxiety in dementia, often leading to inappropriate and sometimes problematic use of medication. Cognitive Behavioural Therapy (CBT) focuses on the interplay between thoughts, feelings and behaviour. 3 small case studies have evaluated CBT for anxiety in dementia, all reporting clinically meaningful reductions in anxiety and other changes including improved mood. Now the potential for CBT in people with dementia has been demonstrated, a pilot RCT is required Aims The key research question, “How effective is CBT for anxiety in dementia?”; will be addressed in a manner consistent to the MRC’s framework of complex interventions. Aims: (1) To develop a CBT for anxiety in dementia manual, through identifying the existing evidence; which will be modelled e.g. through a consensus process. (2) To assess the feasibility of the intervention through a single-blind, pilot RCT on CBT versus treatment as usual (TAU) for people with dementia and their carers. Additionally,ssues including acceptability, compliance, recruitment and retention will be explored and qualitative interviews conducted with service-users. (3) To make the intervention widely available online, whilst using the pilot data to prepare for a definitive RCT. Plan of Investigation The applicants’ systematic review and focus groups on anxiety in dementia will inform the development of a draft CBT manual, which will be modified through a consensus process, focus groups and field testing. 50 people with mild to moderate dementia and anxiety, and their carers; will be recruited to a two-armed RCT and receive either CBT or TAU. The adapted CBT intervention will involve 10 weekly sessions that will teach people new skills to manage their anxiety, with the support of their carer. Blind assessments will be conducted at baseline, 12-week follow-up and at 6 months, to detect changes in anxiety, quality of life, cognition, behavioural function, mood and relationship with carer. Qualitative interviews will be used to gather service-users’ perspectives on the intervention. Potential Impact We will produce a CBT training manual for staff, enabling widespread use by NHS professionals and prepare the ground for a definitive RCT offering an alternative to medication. CBT could lead to significant and generalised benefits, reducing excess disability and social exclusion, e.g. by improving cognitive and behavioural functioning and reducing carer burden. Costs to the NHS might be reduced through decreased use of medication, services (e.g. GP visits) and reduced nursing home placement. Without this research there is a danger that people with dementia complicated by anxiety will be denied access to potentially effective psychological treatments.

Plain English Summary

There are about 700,000 people with dementia in the UK and up to two thirds of them also have anxiety. This can worsen their cognitive (e.g. memory and language) and behavioural problems. It can also lead to relationship difficulties, physical dependency and increase the risk of being admitted to a care home. The Department of Health’s first ever ‘National Dementia Strategy’ sets standards for best care for people with dementia, including ensuring early treatment (DoH, 2009). Cognitive Behavioural Therapy (CBT) is a person-centred talking therapy that addresses the thoughts and feelings associated with anxiety and teaches people new skills to manage it. It is the treatment of choice for anxiety in other groups, including older people in general. There is some evidence from research with individual cases that CBT has great potential to help reduce anxiety and improve mood in people with dementia. This project will test whether CBT reduces anxiety in people with dementia and whether it improves their cognitive problems, everyday behaviour and quality of life. We will also test if it improves relationships with carers, as they develop new skills to help support their relative. The study will be a pilot trial. 50 people with mild to moderate dementia and anxiety (and their carer) will be randomly allocated to receive either CBT or treatment as usual (typically medication or no treatment). For the NHS, this method of treatment may reduce costs e.g. through reductions in GP visits, use of medication and admission to care homes. If the results of the trial are positive, we will apply for funding for a full-scale clinical trial. We also aim to produce a CBT training manual for dementia health professionals (e.g. Psychologists and Nurses) that will be freely available online. This study is important because anxiety increases disability in dementia and treatment options are limited, often leading to unnecessary use of medication which can have serious side-effects.