Abstract
BackgroundThere is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson’s disease dementia and dementia with Lewy bodies. Cognitive rehabilitation is a goal-oriented behavioural intervention which focuses on improving everyday functioning through management of cognitive difficulties; it has been shown to be effective in Alzheimer’s disease. To date, no studies have assessed its potential efficacy for addressing the impact of cognitive impairment in people with Parkinson’s disease or dementia with Lewy bodies.Methods/designParticipants (n = 45) will be recruited from movement disorders, care for the elderly and memory clinics. Inclusion criteria include: a diagnosis of Parkinson’s disease, Parkinson’s disease dementia or dementia with Lewy bodies according to consensus criteria and an Addenbrooke’s Cognitive Examination – III score of ≤ 82. Exclusion criteria include: a diagnosis of any other significant neurological condition; major psychiatric disorder, including depression, which is not related to the patient’s Parkinson’s disease and unstable medication use for their physical or cognitive symptoms. A single-blind pilot randomised controlled trial, with concurrent economic evaluation, will compare the relative efficacy of cognitive rehabilitation with that of two control conditions. Following a goal-setting interview, the participants will be randomised to one of the three study arms: cognitive rehabilitation (eight weekly sessions), relaxation therapy (eight weekly sessions) or treatment as usual. Randomisation and treatment group allocation will be carried out by a clinical trials unit using a dynamic adaptive sequential randomisation algorithm. The primary outcomes are patients’ perceived goal attainment at a 2-months post-intervention assessment and a 6-months follow-up. Secondary outcomes include patients’ objective cognitive performance (on tests of memory and executive function) and satisfaction with goal attainment, carers’ perception of patients’ goal attainment and patients’ and carers’ health status and psychosocial well-being, measured at the same time points. Cost-effectiveness will be examined to explore the design of a larger cost-effectiveness analysis alongside a full trial.DiscussionThis pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson’s disease dementia and dementia with Lewy bodies. The results of the study will inform the design of a fully powered randomised controlled trial.Trial registrationISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015
Highlights
There is growing interest in developing non-pharmacological treatments to address the cognitive deficits apparent in Parkinson’s disease dementia and dementia with Lewy bodies
This pilot study will evaluate the application of cognitive rehabilitation for the management of cognitive difficulties associated with Parkinson’s disease dementia and dementia with Lewy bodies
The results of the study will support the selection of outcome measures and the estimation of parameters for a larger RCT of cognitive rehabilitation (CR) in Parkinson’s disease (PD) dementia
Summary
This study will provide preliminary indications of efficacy for CR in the management of dementias associated with Parkinson’s disease. It is possible that some participants may find it challenging to confront their difficulties, but the therapist will provide support as they engage in this process, and the intervention protocol incorporates attention to managing emotional reactions As this is a short pilot trial and there have been no other trials of CR in PD or DLB, it is not considered unethical to withhold CR from the comparator groups. TJW: Trial management, recruitment and screening of participants, data collection, preparation and drafting of study protocol, drafting of manuscript. ZH: Study design, preparation and drafting of study protocol, statistical analysis plan, review of manuscript. RTE: Study design, preparation and drafting of study protocol, statistical analysis plan, review of manuscript.
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