title: Cognitive rehabilitation for Parkinson’s disease dementia: a study protocol for a pilot randomised controlled trial.
abstract: 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. 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.
  
  
  
  Participants (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.
  
  
  
  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 inform the design of a fully powered randomised controlled trial.
  
  
  
  ISRCTN16584442 DOI 10.1186/ISRCTN16584442 13 April 2015.
authors.affiliation: Department of Care for the Elderly, Betsi Cadwaladr University Health Board, Llandudno, UK. j.v.hindle@bangor.ac.uk.|North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, Brigantia Building, Penrallt Road, Bangor, LL57 2AS, UK. j.v.hindle@bangor.ac.uk.
authors.forename: John V
authors.initials: JV
authors.lastname: Hindle
authors.affiliation: School of Psychology, Bangor University, Bangor, UK.
authors.forename: Tamlyn J
authors.initials: TJ
authors.lastname: Watermeyer
authors.affiliation: Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, North Wales, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Roberts
authors.affiliation: Centre for Research in Ageing and Cognitive Health (REACH), School of Psychology, University of Exeter, Exeter, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Martyr
authors.affiliation: Centre for Health Economics and Medicines Evaluation (CHEME), Bangor University, Bangor, UK.
authors.forename: Huw
authors.initials: H
authors.lastname: Lloyd-Williams
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, Brigantia Building, Penrallt Road, Bangor, LL57 2AS, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Brand
authors.affiliation: Cefni Hospital, Llangefni, Anglesey, UK.
authors.forename: Petra
authors.initials: P
authors.lastname: Gutting
authors.affiliation: North Wales Organisation for Randomised Trials in Health (NWORTH), Bangor University, Brigantia Building, Penrallt Road, Bangor, LL57 2AS, UK.
authors.forename: Zoe
authors.initials: Z
authors.lastname: Hoare
authors.affiliation: Centre for Health Economics and Medicines Evaluation (CHEME), Bangor University, Bangor, UK.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: Division of Mental Health and Learning Disabilities, Betsi Cadwaladr University Health Board, North Wales, UK.
authors.forename: Linda
authors.initials: L
authors.lastname: Clare
mesh_terms: D002985:Clinical Protocols; D003071:Cognition; D015928:Cognitive Behavioral Therapy / Q000191:economics; D003362:Cost-Benefit Analysis; D003704:Dementia / Q000175:diagnosis / Q000209:etiology / Q000523:psychology / Q000534:rehabilitation*; D017048:Health Care Costs; D006801:Humans; D010300:Parkinson Disease / Q000150:complications / Q000175:diagnosis / Q000523:psychology / Q000534:rehabilitation*; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012107:Research Design; D016037:Single-Blind Method; D013997:Time Factors; D016896:Treatment Outcome; D014852:Wales
keywords: Cognitive intervention; Cost-effectiveness; Parkinsonism; Quality of life