A psychosocial therapy to benefit people with Parkinson’s-related dementia (INVEST)

ISRCTN	ISRCTN11455062
DOI	https://doi.org/10.1186/ISRCTN11455062
Protocol serial number	20631
Sponsor	Manchester Mental Health & Social Care Trust
Funder	National Institute for Health Research

Submission date: 17/03/2016
Registration date: 18/03/2016
Last edited: 26/04/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Parkinson’s disease (PD) is a long-term medical condition which is caused by the gradual loss of nerve cells (neurons) in a part of the brain called the substantia nigra. These neurons are normally responsible for producing dopamine, a chemical messenger (neurotransmitter) which carries signals around the brain that help to coordinate movement. In people suffering from PD, these neurons gradually die over time, causing the level of dopamine in the brain to gradually fall. As the levels of dopamine become lower, the brain is unable to coordinate movement as effectively, causing abnormal movements such as stiffness, tremor (uncontrollable shaking) and slowness of movement (bradykinesia). Parkinson’s related dementia is a gradual decline of cognitive function (thinking and reasoning) that develops in someone with Parkinson’s disease. There are two forms of dementia associated with PD: Parkinson’s disease dementia, PDD (which is diagnosed when someone has had PD for some time) and dementia with Lewy bodies, DLB (which is diagnosed earlier or at the same time as someone is diagnosed with dementia). Increasing availability of psychosocial treatments (psychological therapy which help people develop the social, emotional and intellectual skills they need in order to get by) for people with dementia on the NHS 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 a PDD and DLB. For these patients, who make up around 7-10% of dementia cases, there is only very limited drug-bassed treatments available. Without adequate disease management, the risk of these patients being admitted to care is high and providing psychosocial therapies could help to reduce this risk. The aim of this study is to find out whether a new psychosocial therapy called cognitive stimulation therapy (CST) could help to improve cognitive function and quality of life in patients with Parkinson’s-related dementia.

Who can participate?
Adults with dementia who are well enough to take part in the therapy and their carer

What does the study involve?
Patients and their carers are randomly allocated to one of two groups. Couples in the first group receive a 10 week course of cognitive stimulation therapy (CST). This involves taking part in two-three 30 minute sessions every week in the patient’s home. Those in the second group continue to receive treatment as usual and do not take part in any additional treatment during the study.

What are the possible benefits and risks of participating?
Not provided at time of registration.

Where is the study run from?
University of Manchester (UK)

When is the study starting and how long is it expected to run for?
February 2016 to October 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Sheree McCormick
sheree.mccormick@manchester.ac.uk

Contact information

Dr Sheree McCormick
Scientific

University of Manchester
Jean MacFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone	+44 (0)161 306 7494
Email	sheree.mccormick@manchester.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A psychosocial therapy to benefit people with Parkinson’s-related dementia: a feasibility and exploratory pilot study of individual cognitive stimulation therapy (INVEST)
Study acronym	INVEST
Study objectives	The aim of this study is to investigate whether it is feasible to implement individual Cognitive Stimulation Therapy for people with Parkinson's disease with mild cognitive impairment (PD-MCI), dementia in Parkinson's disease (PDD) and dementia with lewy bodies (DLB).
Ethics approval(s)	15/YH/0531
Health condition(s) or problem(s) studied	Topic: Dementia; Subtopic: Parkinson's Disease; Disease: Parkinson's Disease
Intervention	Participants are randomly allocated to one of two groups: Active iCST group Each caregiver-participant dyad will receive a 10-week course of Cognitive Stimulation Therapy. This involves completing two-three activity sessions per week, each session lasting approximately 30 minutes. The therapy is delivered to the participant by the caregiver at home. Treatment as usual In the 'Treatment as usual’ (TAU) arm, the comparator, dyads will not receive any additional intervention. TAU is defined as standard NHS treatment for the individual’s condition and symptomology. In general, the services offered to this group will also be available to those in the active treatment group, the study will, therefore, be examining the additional effects of individual Cognitive Stimulation Therapy. Total duration of treatment, including a two-week lead-in period is 12 weeks. The two-week lead-in period is provided to ensure the caregiver is confident in delivering the therapy in an effective and efficient manner.
Intervention type	Behavioural
Primary outcome measure(s)	1. Quality of life is measured using the Parkinson’s Disease Questionnaire-39 2. Cognitive functioning is measured using the Addenbrook’s Cognitive Examination - Revised Version
Key secondary outcome measure(s)	1. Apathy is measured using the Lille Apathy Rating Scale 2. Caregiver burden is measured using the Zarit Burden Interview
Completion date	31/10/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	186
Total final enrolment	76
Key inclusion criteria	Caregiver inclusion criteria: 1. Caregiver of a person with PD-MCI, PDD or DLB: Must live with or be carer for someone who has a diagnosis of PDMCI, PDD or DLB 2. Must be well enough to deliver 20 – 30 minute sessions of iCST, two or three times per week Patient inclusion criteria: 1. Must have received a diagnosis of probable PD-MCI, PDD or DLB. Diagnosis will be based on standard clinical diagnostic criteria (Emre et al, 2007; McKeith et al., 2005) determined by the referring clinician and verified by the lead applicant (IL). 2. Must be willing to participate in 20 – 30 minute sessions of iCST, two or three times per week 3. Must be well enough to participate in 20 – 30 minute sessions of iCST, two or three times per week 4. Must be stable on medication regime four weeks prior study entry
Key exclusion criteria	Caregiver exclusion criteria: 1. Not a caregiver for someone with PD-MCI, PDD or DLB 2. Cannot understand English or are non-literate 3. Severe physical illness 4. Diagnosis of dementia 5. The person being cared for meets the patient exclusion criteria Patient exclusion criteria: 1. Unwilling to participate in 20 – 30 minute sessions of iCST, two or three times per week 2. Not well enough to participate in 20 – 30 minute sessions of iCST, two or three times per week 3. Caregiver contact less than 3 time per week 4. No caregiver (or caregiver not willing) to deliver therapy and complete study assessments 5. Lives in residential care 6. Cannot understand English or are non-literate 7. Severe physical illness
Date of first enrolment	15/02/2016
Date of final enrolment	31/10/2017

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Manchester

Jean MacFarlane Building
Oxford Road
Manchester
M13 9PL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2019	05/06/2019	Yes	No
Results article		04/07/2019	26/04/2023	Yes	No
Protocol article	protocol	19/06/2017		Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

26/04/2023: Publication reference added.
05/06/2019: Publication reference and total final enrolment added.
18/10/2017: Internal review.
22/06/2017: Publication reference added.