Psychosocial therapy for Parkinson's-related dementia: Study protocol for the INVEST randomised controlled trial

Sheree A McCormick, Kathryn R McDonald, Sabina Vatter, Vasiliki Orgeta, Ellen Poliakoff, Sarah Smith, Monty A Silverdale, Bo Fu, Iracema Leroi

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Abstract

Introduction Parkinson's disease (PD) with mild cognitive impairment (MCI-PD) or dementia (PDD) and dementia with Lewy bodies (DLB) are characterised by motor and â € non-motor' symptoms which impact on quality of life. Treatment options are generally limited to pharmacological approaches. We developed a psychosocial intervention to improve cognition, quality of life and companion burden for people with MCI-PD, PDD or DLB. Here, we describe the protocol for a single-blind randomised controlled trial to assess feasibility, acceptability and tolerability of the intervention and to evaluate treatment implementation. The interaction among the intervention and selected outcome measures and the efficacy of this intervention in improving cognition for people with MCI-PD, PDD or DLB will also be explored. Methods and analysis Dyads will be randomised into two treatment arms to receive either â € treatment as usual' (TAU) or cognitive stimulation therapy specifically adapted for Parkinson's-related dementias (CST-PD), involving 30 min sessions delivered at home by the study companion three times per week over 10 weeks. A mixed-methods approach will be used to collect data on the operational aspects of the trial and treatment implementation. This will involve diary keeping, telephone follow-ups, dyad checklists and researcher ratings. Analysis will include descriptive statistics summarising recruitment, acceptability and tolerance of the intervention, and treatment implementation. To pilot an outcome measure of efficacy, we will undertake an inferential analysis to test our hypothesis that compared with TAU, CST-PD improves cognition. Qualitative approaches using thematic analysis will also be applied. Our findings will inform a larger definitive trial. Ethics and dissemination Ethical opinion was granted (REC reference: 15/YH/0531). Findings will be published in peer-reviewed journals and at conferences. We will prepare reports for dissemination by organisations involved with PD and dementia.

Original languageEnglish
Article numbere16801
JournalBMJ Open
Volume7
Issue number6
Early online date1 Jun 2017
DOIs
Publication statusPublished - 19 Jun 2017

Keywords

  • Behavioral Symptoms/diagnosis
  • Caregivers/psychology
  • Cognitive Dysfunction/etiology
  • Cost of Illness
  • Disease Management
  • Female
  • Humans
  • Lewy Body Disease/etiology
  • Male
  • Parkinson Disease/complications
  • Quality of Life
  • Research Design
  • Spouses/psychology
  • Symptom Assessment/methods
  • Treatment Outcome

Research Beacons, Institutes and Platforms

  • Manchester Institute for Collaborative Research on Ageing

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