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

McCormick, SA; McDonald, KR; Vatter, S; Orgeta, V; Poliakoff, E; Smith, S; Silverdale, MA; ... Leroi, I; + view all (2017) Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial. BMJ Open , 7 (6) , Article e016801. 10.1136/bmjopen-2017-016801. Green open access

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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 '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 '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. TRIAL REGISTRATION NUMBER: ISRCTN (ISRCTN11455062).

Type: Article
Title: Psychosocial therapy for Parkinson's-related dementia: study protocol for the INVEST randomised controlled trial
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1136/bmjopen-2017-016801
Publisher version: http://doi.org/10.1136/bmjopen-2017-016801
Language: English
Additional information: This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/ licenses/by/4.0/
Keywords: Complex intervention, dementia with Lewy bodies (DLB), feasibility and exploratory study, mild cognitive impairment in PD (MCI-PD), parkinson’s disease dementia (PDD), pilot trial, process analysis., psychosocial therapy, quality of life
UCL classification: UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > Division of Psychiatry
URI: https://discovery.ucl.ac.uk/id/eprint/1560627
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