Cognitive Stimulation Therapy (CST) for people with intellectual disabilities and dementia
| ISRCTN | ISRCTN88614460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88614460 |
| EudraCT/CTIS number | Nil Known |
| IRAS number | 306756 |
| Secondary identifying numbers | IRAS 306756, CPMS 52053 |
- Submission date
- 07/03/2022
- Registration date
- 15/03/2022
- Last edited
- 31/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
People with learning disabilities make up one percent of the population. Learning disabilities are often described as problems and difficulties with memory and attention that affect day-to-day life, normally appearing before the age of 18 years. Nowadays, people with these difficulties are living longer and therefore are at higher risk of developing dementia.
Cognitive Stimulation Therapy (CST) is the only recommended non-drug treatment by the NHS for people living with dementia. It is proven to improve quality of life as well as slowing down the loss of memory and attention problems. Sadly, people with an Intellectual Disability and dementia have been excluded from studies evaluating how effective it is. As the number of people with these difficulties is increasing it is important to evaluate whether it is also beneficial for this population.
Evidence from an exploratory study of an individually delivered programme by a family caregiver (as opposed to group) delivered CST indicated that people with an Intellectual Disability and dementia can engage with the proposed programme; however treatment delivery was challenging for carers. This suggested that group CST, which is delivered by a trained professional may be a more practical way of delivery.
This research seeks to find out if it will be possible to carry out an evaluation of group CST for this population using full randomised controlled trial.
Who can participate?
People who have been diagnosed with an Intellectual Disability and dementia.
What does the study involve?
We plan to carry out a study of 50 people across five NHS trusts in Greater London. We will allocate people to either group CST or treatment as usual. This will be done randomly by a computer, so everyone will have an equal chance of receiving CST or treatment as usual. Group CST will involve 14 CST sessions over 7 weeks delivered by trained staff, using a modified manual. Researchers will test participants before and after the group CST period, to see whether CST led to any changes compared to treatment as usual. We will also interview participants, their relatives and the staff running the groups, asking them about their experience of the groups.
What are the possible benefits and risks of participating?
The benefit in partaking is if people are in the treatment they could possibly gain benefit from the groups. IT may help in slowing down the progression of dementia. The social aspect of the groups may also be enjoyable and present an opportunity to meet others with the same diagnosis. The risk may be they may not enjoy the groups. People may also not enjoy the questionnaires before and after the groups.
Where is the study run from?
The main site of the study is North East London Foundation Trust (UK) and will be lead by our Research and Development department. However, the trial treatments and all involvement of the participants will be from within their local community learning disabilities teams.
When is the study starting and how long is it expected to run for?
March 2021 to February 2024
Who is funding the study?
The study is funded by the National Institute for Health Research (NIHR) and is under research for Patient Benefit (RfPB) (UK)
Who is the main contact?
Professor Aimee Spector, a.spector@ucl.ac.uk
Contact information
Public, Scientific, Principal Investigator
1-19 Torrington place
London
WC1E 7HB
United Kingdom
| Phone | +44 7958 993973 |
|---|---|
| a.spector@ucl.ac.uk |
Study information
| Study design | Multi centre interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | 41308 PIS Carer interview Information Sheet v1 02Dec2021.pdf |
| Scientific title | Cognitive Stimulation Therapy (CST) for people with intellectual disabilities and dementia, a feasibility, randomised controlled trial |
| Study acronym | CST IDD |
| Study hypothesis | To assess the feasibility and acceptability of a randomised controlled trial of group CST for people with ID and dementia compared to treatment as usual. The results of this study will inform the design of a future definitive RCT |
| Ethics approval(s) | Approved 07/02/2022, Essex Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 2071048227; essex.rec@hra.nhs.uk), ref: 21/EE/0247 |
| Condition | Dementia in people with intellectual disabilities |
| Intervention | Current intervention as of 17/03/2022: Fifty individuals with intellectual disabilities and dementia will be randomised to either the intervention group or control group (treatment as usual). Randomisation will occur after informed consent has been given and baseline assessments completed. Each arm will have 25 participants and be divided into 5 or more CST groups with up to 5 participants in each. All participants will be randomised using the computer program NWORTH. Half will be randomised into the Intervention arm and half into the Control/Treatment as usual arm. All participants will have a baseline assessment of cognitive ability, mood, quality of life and health questionnaires as well as a costs and receipt inventory to measure use of health services. The intervention arm will receive Cognitive Stimulation Therapy that has been adapted for people with Intellectual Disability. This is a psychosocial therapy group for people with dementia. It consists of activities aimed at exercising different types of cognitive abilities, as well as orientating group participants to place and time. The groups are run for 45 minutes twice a week for 7 weeks therefore group members receive 14 sessions in total. This group will also continue to receive any treatments from their health teams that they already receive including any anti-dementia medication. Following this intervention the assessments from baseline will be repeated within 2 weeks of completion of the groups. The control groups will have the treatment as usual from their health teams, they will receive the same baselines and will not attend the intervention. They will receive the follow-up assessments at the same time as the intervention groups, between 8-9 weeks later. Previous intervention: 50 individuals with intellectual disabilities and dementia will be randomised to either the intervention group or control group (treatment as usual). Randomisation will occur after informed consent has been given and baseline assessments completed. Each arm will have 25 participants and be divided into 5 or more CST groups with up to 5 participants in each. All participants will be randomised using the computer program NWORTH 50% into the Intervention arm and 50% into the Control/Treatment as usual arm. All participants will have a baseline assessment of cognitive ability, mood, quality of life and health questionnaires as well as a costs and receipt inventory to measure use of health services. The intervention arm will receive Cognitive Stimulation Therapy that has been adapted for people with learning disabilities. This is a psychosocial therapy group for people with dementia. It consists of activities aimed at exercising different types of cognitive abilities as well as orientating group participants to place and time. The groups are run for 45 minutes twice a week for 7 weeks therefore group members receive 14 sessions in total. This group will also continue to receive any treatments from their health teams that they already receive including any anti-dementia medication. Following this intervention the assessments from baseline will be repeated within 2 weeks of completion of the groups. The control groups will have the treatment as usual will receive the same baselines and will not attend the intervention, they will go on to receive all treatment they receive from their health teams. They will receive the follow-up assessments at the same time as the intervention groups, between 8-9 weeks later. |
| Intervention type | Behavioural |
| Primary outcome measure | Current primary outcome measures as of 14/03/2023: 1. Cognitive functioning measured using the Severe Impairment Battery (SIB) and Dementia in Learning Disabilities Questionnaire (DLD) at 2 weeks prior to the intervention and then followed up 2 weeks following the intervention 2. Adaptive functioning measured using The Dementia in Learning Disabilities Questionnaire (DLD) at 2 weeks prior to the intervention and 2 weeks following the intervention 3. Quality of life measured using the Quality of life in Alzheimer’s Dementia (QoL-AD) proxy questionnaire and the EQ-5L-5D quality of health questionnaires at 2 weeks prior to the intervention and two weeks following the intervention 4. Feasibility of collecting the cost-effectiveness measures measured using Clinical Service Receipt Inventory (CSRI) at 2 weeks prior to the intervention and two weeks following the intervention 5. A process evaluation will include qualitative interviews with participants, staff and carers to identify aspects of the intervention and study methods including adherence at the end of the intervention 6. Overall attendance amongst the CST group participants by recording the attendance of each participant in each group session. This will be given to the researchers following the intervention 7. Feasibility of recruitment measured using recruitment, eligibility rate, consent rate and retention data in study records at the end of the intervention 8. To assess the suitability of study outcome measures and determine the primary outcome measure for a future larger RCT measured using the data outcomes of the tools used at pre- and post-intervention 9. Acceptability and feasibility of CST measured using overall attendance data for the CST groups in study records, and fidelity measured using recordings of the groups at the end of the intervention Previous primary outcome measures: 1. Cognitive functioning measured using the Severe Impairment Battery (SIB) and Dementia in Learning Disabilities Questionnaire (DLD) at 2 weeks prior to the intervention and then followed up 2 weeks following the intervention. 2. Adaptive functioning measured using The Dementia in Learning Disabilities Questionnaire (DLD) at 2 weeks prior to the intervention and 2 weeks following the intervention. 3. Quality of life measured using the Quality of life in Alzheimer’s Dementia (QoL-AD) proxy questionnaire and the EQ-5L-5D quality of health questionnaires at 2 weeks prior to the intervention and two weeks following the intervention. 4. Feasibility of collecting the cost-effectiveness measures measured using Clinical Service Receipt Inventory (CSRI) at 2 weeks prior to the intervention and two weeks following the intervention. 5. A process evaluation will include qualitative interviews with participants, staff and carers to identify aspects of the intervention and study methods including adherence at the end of the intervention. 6. Overall attendance amongst the CST group participants by recording the attendance of each participant in each group session. This will be given to the researchers following the intervention. |
| Secondary outcome measures | The fidelity of delivery of the groups measured using: 1. Number of group CST sessions completed by each participant measured using the group attendance register at the end of the data collection. 2. Level of engagement in the sessions measured using CST participation forms developed alongside the CST manual recorded during the sessions collected after the interventions by the researchers. |
| Overall study start date | 24/03/2021 |
| Overall study end date | 29/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | Current participant inclusion criteria as of 14/03/2023: 1. Premorbid mild or moderate intellectual disabilities (based on clinical notes) 2. Aged 18 and over 3. Clinical diagnosis of mild or moderate dementia based on service records 4. Ability to provide informed consent or (if the participant lacks capacity) availability of a personal consultee who has agreed to participate in the study 5. Ability to communicate in English Previous participant inclusion criteria: 1. Mild or moderate Learning disabilities 2. ICD-10 diagnosis of mild or moderate dementia |
| Participant exclusion criteria | Current participant exclusion criteria as of 14/03/2023: 1. Significant visual or hearing impairment that may interfere with participation 2. Significant physical illness or disability, affecting the ability to attend groups 3. Significant behavioural problems that could affect participation (e.g. aggressive behaviour) Previous participant exclusion criteria: 1. Severe learning disabilities 2. Severe dementia 3. Visual or hearing impairment that prevents participation |
| Recruitment start date | 15/03/2022 |
| Recruitment end date | 31/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
157 Barley Lane
Ilford
IG3 8XJ
United Kingdom
Hornchurch
RM11 1XL
United Kingdom
London
E17 6QU
United Kingdom
Dagenham
RM8 3HR
United Kingdom
Ilford
IG6 1HZ
United Kingdom
Colindale
London
NW9 4EW
United Kingdom
London
N22 8HQ
United Kingdom
London
EN1 3SY
United Kingdom
St. Marks Road
London
W11 1RG
United Kingdom
London
W12 7FG
United Kingdom
London
NW8 8LW
United Kingdom
London
WC1H 9JE
United Kingdom
London
N5 1NS
United Kingdom
London
E15 4LY
United Kingdom
London
E1 4DG
United Kingdom
London
E8 1DY
United Kingdom
Eastway
Countess of Chester Health Park
Chester
CH2 1BQ
United Kingdom
Sponsor information
Hospital/treatment centre
1st Floor Maggie Lilley Suite
Goodmayes Hospital
157 Barley lane
Goodmayes
Ilford
London
IG3 8XJ
England
United Kingdom
| Phone | +44 300 555 1200 Ext: 64485 |
|---|---|
| fiona.horton@nelft.nhs.uk | |
| Website | http://www.nelft.nhs.uk/ |
"ROR" |
https://ror.org/023e5m798 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 28/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Peer reviewed papers: We will follow the approach from other research studies sponsored at NELFT and follow the publication policy agreed with the Study Steering Group and a systematic plan, including authorship. Methodology papers including those describing the development of methodology and the protocol are likely to be targeted at major online free to access publications (e.g. Trials, BMC Geriatrics, BMC Health Services Research). Major papers including the results of qualitative and quantitative results from the feasibility study and cost effectiveness will be targeted high impact journals. 2. Other and PPI publications: Articles will be produced for relevant professional and educational journals (e.g. Health Services Journal, Generations, Signpost) and newsletters for lay readers including those for carers and the voluntary sector (e.g. Age UK newsletter) and websites. 3. Conference presentations: We will submit abstracts for major conferences and present locally (e.g. NELFT R&D conference). We will specifically target conferences relevant to policy and commissioning services for dementia and ID services. This approach has been very successful in other research studies delivered at the involved Trust where a number of researchers have received acclaim for the quality of their presentations. 4. Dissemination of study progress through the current NELFT R&D social media channels of Facebook and twitter accounts. We will aim to translate the research findings into the NHS and wider healthcare community in order to provide improvements in service delivery, patient health and/or wellbeing by: a) Raised awareness of the co-morbidity of dementia amongst people with Intellectual Disabilities. There is currently a referrals pathway that has been created at NELFT in order to develop and improve services for people with ID who develop dementia. We will link at all times with these pathways leads. We hope this trial will raise awareness of the importance of screening for dementia amongst people with ID and offer hope to those who live with these two comorbidities. b) Dissemination and policy change. NELFT and part of the applicant team has been involved in the past in a successful trial influencing NICE guidelines and we have been extremely effective in disseminating the tested intervention Cognitive Stimulation Therapy (CST) for dementia. If the study results are positive, we would follow asimilar dissemination route with the aim of influencing public health guidance for people with ID policy and practice, e.g. NICE, and commissioning guidance. We expect that in just over three years, this proposed trial could lead to changes in the way ID services offers support for people with ID and dementia is organised with opportunities for national implementation. The applicants' networks and the key drivers to influence policy means there could be extensive implementation of the intervention by ID services across the UK and influence guidelines for the treatment of dementia in people with ID. |
| IPD sharing plan | Current IPD sharing statement as of 14/03/2023: The datasets generated during and/or analysed during the current study are/will be available upon request from Aimee Spector Professor of Clinical Psychology of Aging, a.spector@ucl.ac.uk and Dr Afia Ali, Consultant Psychiatrist East London Foundation NHS Trust, afia.ali4@nhs.net. All IPD collected during the trial, can be shared after de-identification. All data in the study is anonymised and no personally identifiable data is used in the publication or analysis of the data in this trial. Data will be available beginning 3 months and ending 5 years following article publication. This information will be available to Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose. The availability is limited to this because we do not have ethical approval and consent from participants to use the data for secondary analysis. Previous IPD sharing statement: The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Carer version version 1 |
02/12/2021 | 08/03/2022 | No | Yes |
| Participant information sheet | Nominated consultee version version 2 |
21/01/2022 | 08/03/2022 | No | Yes |
| Participant information sheet | Personal consultee version version 3 |
21/01/2022 | 08/03/2022 | No | Yes |
| Participant information sheet | Service user version version 3 |
21/01/2022 | 08/03/2022 | No | Yes |
| Protocol file | version 8 | 15/12/2021 | 08/03/2022 | No | No |
| Protocol article | 28/04/2023 | 02/05/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- 41308 PIS Carer interview Information Sheet v1 02Dec2021.pdf
- Carer version
- 41308 PIS information sheet service user CSTIDD trial v3 21Jan2022.pdf
- Service user version
- 41308 PIS Nominated consultee Information Sheet CSTIDD v2 21Jan2022.pdf
- Nominated consultee version
- 41308 PIS Personal Consultee Information Sheet CSTIDD v3 21Jan2022.pdf
- Personal consultee version
- 41308 CST-IDD protocol v8 15Dec2021.pdf
Editorial Notes
31/03/2025: Contact details updated.
10/10/2023: The study participating centres Harrow Learning Disabilities Centre, Brent Learning Disabilities Team, Hillingdon Community Learning disabilities Team were removed.
05/07/2023: The recruitment end date has been changed from 01/07/2023 to 31/10/2023.
02/05/2023: Publication reference added.
14/03/2023: The following changes have been made to the study record:
1. The primary outcome measures have been changed.
2. The overall trial end date has been changed from 15/07/2023 to 29/02/2024 and the plain English summary has been updated accordingly.
3. The participant inclusion criteria have been changed.
4. The participant exclusion criteria have been changed.
5. Trial participating centre Centre for Autism, Neurodevelopmental Disorders, and Intellectual Disability (CANDDID) was added.
6. The individual participant data (IPD) sharing statement and summary have been changed.
01/04/2022: Internal review.
17/03/2022: The following changes have been made:
1. The public title has been changed from "Cognitive Stimulation Therapy (CST) for people with learning disabilities" to "Cognitive Stimulation Therapy (CST) for people with intellectual disabilities and dementia".
2. The scientific title has been changed from "Cognitive Stimulation Therapy (CST) for people with intellectual disabilities, a mixed methods feasibility trial" to "Cognitive Stimulation Therapy (CST) for people with intellectual disabilities and dementia, a feasibility, randomised controlled trial".
3. The intervention has been updated.
4. The plain English summary has been updated.
08/03/2022: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
