Psychosocial Therapy to Benefit Patients with Parkinson’s-related Dementia: A Feasibility and Exploratory Pilot Study
Award Number
PB-PG-0613-31058Programme
Research for Patient BenefitStatus / Stage
CompletedDates
1 November 2014 -1 May 2018
Duration (calculated)
03 years 06 monthsFunder(s)
NIHRFunding Amount
£333,942.00Funder/Grant study page
NIHRContracted Centre
Greater Manchester Mental Health NHS Foundation TrustPrincipal Investigator
Dr iracema LeroiPI Contact
iracema.leroi@gbhi.orgPI ORCID
0000-0003-1822-3643WHO Catergories
Development of novel therapiesRisk reduction intervention
Disease Type
Dementia (Unspecified)CPEC Review Info
| Reference ID | 106 |
|---|---|
| Researcher | Reside Team |
| Published | 12/06/2023 |
Data
| Award Number | PB-PG-0613-31058 |
|---|---|
| Status / Stage | Completed |
| Start Date | 20141101 |
| End Date | 20180501 |
| Duration (calculated) | 03 years 06 months |
| Funder/Grant study page | NIHR |
| Contracted Centre | Greater Manchester Mental Health NHS Foundation Trust |
| Funding Amount | £333,942.00 |
Abstract
Increasing the NHS availability and the evidence-base for psychosocial therapies for dementia is a key objective of the National Dementia Strategy (2009) and other national dementia policy drivers. However there is almost no evidence to support their use in people with more complex forms of dementia such as PDD and DLB. Only very limited drug-based treatments are available for these groups which comprise 7-10% of the dementia population. Without adequate management, the risk of being admitted to care is very high. Our PPI and PD expert consultees support the need to extend psychosocial therapies to those with PDD/DLB. We have identified a type of psychosocial therapy, individual Cognitive Stimulation Therapy (CST) that can form the basis of a novel PDD/DLB-specific non-drug intervention. There is evidence that CST is a cost-effective, well-tolerated, easily trained therapy for people with dementia and is already in widespread use in the NHS. It is based on the principle that stimulating engagement in cognitive and social activity enhances cognitive function and quality of life. However, in its present form, CST is not suitable for those with dementias such as PDD/DLB due to the added complexity of their symptoms which includes frequent confusional episodes, marked hallucinations and delusions, high rates of apathy and a myriad of motor symptoms and dependency on carers due to physical disability. Thus, the need remains to develop a therapy suitable for this group of people with complex needs. Plan of investigation in 3 stages: (1) focus groups and Delphi process of caregivers, people with PDD/DLB and PD professionals to provide themes about how existing CST therapy should be adapted for PDD/DLB; (2) an exploratory pilot study of acceptability and tolerability of a draft PDD/DLB-CST therapy manual vs ‘Treatment as Usual’ in people with PDD/DLB and their carers using quantitatively and qualitatively evaluated outcome measures; this will also involve an assessment of the feasibility of recruiting to a larger trial, retention, adherence, evaluation of appropriate outcome measures and sample size determination; and (3) final focus groups to receive feedback on the pilot trial and provide input into a final PDD/DLB-CST manual and study design for the subsequent full RCT. Benefits to patients and NHS: The development of a psychosocial therapy for people with PDD/DLB will fill a significant unmet need because there is as yet no accepted psychosocial therapy for this group and drug therapies are very limited. This study will inform a definitive full-scale trial of a therapy that if successful, will improve cognitive and functional ability, thereby improving quality of life and caregiver burden. More importantly, the benefit for individuals will be seen in achievement of their own personally-set goals. For the NHS, improvement in dementia-related symptoms and reduction in carer burden will reduce the rate of admission to care and the use of health resources.
Aims
To undertake a feasibility and acceptability lead-in study followed by an exploratory pilot trial to inform a subsequent large-scale clinical effectiveness trial of a PDD/DLB-specific psychosocial therapy. To achieve this aim, our objectives are: (1) to develop a PDD/DLB-specific therapy manual and training guide based on CST principles; (2) to ascertain recruitment potential (rates/methods) for the full RCT; (3) to assess acceptability of the therapy through examination of adherence and retention; (4) to define appropriate outcome measures (including service utilisation/health economics measures); (5) to ascertain a sample size for the main study. Key deliverables: a PDD/DLB-CST manual and training guide; a battery of meaningful outcome measures; an understanding of potential barriers to conducting a larger study; and a research protocol for the definitive trial, including sample size calculation. Aims: To undertake a feasibility and acceptability lead-in study followed by an exploratory pilot trial to inform a subsequent large-scale clinical effectiveness trial of a PDD/DLB-specific psychosocial therapy. To achieve this aim, our objectives are: (1) to develop a PDD/DLB-specific therapy manual and training guide based on CST principles; (2) to ascertain recruitment potential (rates/methods) for the full RCT; (3) to assess acceptability of the therapy through examination of adherence and retention; (4) to define appropriate outcome measures (including service utilisation/health economics measures); (5) to ascertain a sample size for the main study. Key deliverables: a PDD/DLB-CST manual and training guide; a battery of meaningful outcome measures; an understanding of potential barriers to conducting a larger study; and a research protocol for the definitive trial, including sample size calculation.