Testing a new brain training treatment (called ‘SMART’) for people with mild cognitive impairment
| ISRCTN | ISRCTN29378862 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29378862 |
| IRAS number | 311736 |
| Secondary identifying numbers | CPMS 54220, IRAS 311736 |
- Submission date
- 05/01/2023
- Registration date
- 25/01/2023
- Last edited
- 25/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Mild cognitive impairment (MCI) is a condition where people experience memory and thinking problems. There is a need for treatments to address these problems and improve quality of life. A new ‘brain training’ treatment has been developed to help people with MCI who have problems with thinking skills. This study aims to test whether this training (known as the SMART programme) is acceptable to people with MCI. It will also assess whether we can do a larger study to test whether SMART improves thinking skills in people with MCI.
Who can participate?
People who have been diagnosed with MCI and are experiencing problems with their thinking skills
What does the study involve?
Participants will be asked to do some tests of thinking skills and fill in some forms about their problems with thinking, mood, and health. Participants will then be put into three groups by chance:
Group 1: Receives the online SMART treatment in addition to their usual care (often informational support). SMART treatment involves doing a series of puzzles. These puzzles are designed to train key skills that support thinking and new learning.
Group 2: Receives a different online brain training treatment in addition to their usual care. This brain training treatment involves doing a series of puzzle games that have shown promise in previous research.
Group 3: Receives usual care alone.
Three and six months later, participants again complete the tests and forms that they did before treatment. Researchers will also interview some patients about how they found the study and the treatment received.
What are the possible benefits and risks of participating?
The researchers cannot promise the study will help individual participants but the information they get from this study will help them to decide whether they should develop the SMART programme for future use by people with MCI. Those taking part in this study may ultimately help to improve treatment options for people with MCI.
Participating will take time and may therefore be inconvenient. The SMART programme may be challenging and difficult to understand at first. Participants can stop at any time if they do not wish to continue.
Where is the study run from?
University of Lincoln (UK)
When is the study starting and how long is it expected to run for?
December 2021 to May 2024
Who is funding the study?
National Institute of Health Research (NIHR) Research for Patient Benefit Programme (UK)
Who is the main contact?
Dr Nima Golijani-Moghaddam, smartstudy@lincoln.ac.uk
Contact information
Scientific
University of Lincoln
School of Psychology
Sarah Swift Building
Lincoln
LN5 7AT
United Kingdom
| Phone | +44 (0)1522837733 |
|---|---|
| nmoghaddam@lincoln.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Psychological & Behavioural |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Strengthening Mental Abilities with Relational Training (SMART) for Mild Cognitive Impairment (MCI): a feasibility trial |
| Study acronym | SMART MCI |
| Study hypothesis | Primarily, the aim of this study is to assess the acceptability and feasibility of the SMART programme as a prospective intervention for improving cognitive functioning in people with MCI. Specifically, the study will assess: 1. Acceptability and feasibility of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures 2. Participant recruitment and retention rates 3. Signal of efficacy |
| Ethics approval(s) | Approved 29/11/2022, North West - Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048306; gmeast.rec@hra.nhs.uk), ref: 22/NW/0335 |
| Condition | Mild cognitive impairment |
| Intervention | Participants will be individually randomised at baseline (after consent) in unequal proportions to one of three groups (2:1:1 ratio) using block randomisation (block size 4). Randomisation will be computer generated via the electronic trial database in Castor EDC (Castor Electronic Data Capture, available at: https://castoredc.com). Group 1: SMART training programme Participants in the intervention (SMART training) group will be asked to use the online training programme for 12 weeks and encouraged to use it for at least one 30-minute session per week (recommended minimum) and up to three 30-minute sessions per week (recommended maximum). They will receive phone/video calls from a researcher to support their use of the programme (weekly or as needed). Participants in this group will also receive treatment as usual (described under Group 3, below). Group 2: Active control training Participants in the active control group (other brain training) will be asked to use the online training for 12 weeks and encouraged to use it for at least one 30-minute session per week (recommended minimum) and up to three 30-minute sessions per week (recommended maximum). They will receive phone/video calls from a researcher to support their use of the programme (weekly or as needed). Participants in this group will also receive treatment as usual (described under Group 3, below). Group 3: Treatment as usual Participants in this arm will receive treatment as usual (TAU). Content of TAU for MCI is often informational support (potentially including a one-to-one appointment with an Alzheimer’s Society support worker) but there is no standardised model of MCI follow-up or access to cognitive stimulation therapies. Thus, over the 12-week intervention period, participants are likely to receive no more than one appointment with a support worker or clinician (lasting up to 60 minutes). |
| Intervention type | Behavioural |
| Primary outcome measure | The primary outcome measures in this study relate to the acceptability and feasibility of both the SMART intervention and applied research methods. Primary outcome measures include: 1. Intervention drop-out rate is measured as the proportion of participants in the intervention condition who drop out (complete <6 sessions) over the 3-month intervention period 2. Completion rate for outcome measures is measured as the proportion of missing response data over the 6-month data collection period 3. Recruitment and retention rates are measured in terms of the total number of cases recruited over a 10-month period (as a proportion of eligible referrals) and the proportion retained at 3-month follow-up |
| Secondary outcome measures | The exploratory outcomes are related to the signal of efficacy and indicative estimation of intervention effects (effect sizes and 95% CIs) for the following outcome measures: Primary outcome measures for exploratory estimation of effects: 1. Subjective cognitive functioning measured using the Quick Dementia Rating System (QDRS) at baseline, 3 months, and 6 months 2. Objective cognitive performance (attention, language, visuospatial/constructional abilities, and immediate and delayed memory) is measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at baseline, 3 months, and 6 months 3. Objective cognitive performance (executive functioning) is measured using the Wisconsin Card Sorting Test (WCST) at baseline, 3 months, and 6 months Secondary outcome measures for exploratory estimation of effects: 1. Anxiety is measured using the Generalized Anxiety Disorder Scale-7 (GAD-7) at baseline, 3 months, and 6 months 2. Depression is measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 3 months, and 6 months 3. Participant-identified cognitive problems are measured using the Personal Questionnaire (PQ) at baseline, 3 months, and 6 months 4. Health-related quality of life is measured using the EQ-5D-5L at baseline, 3 months, and 6 months 5. Cognitive impairment-specific health-related quality of life is measured using the Quality of Life in Alzheimer’s Disease (QoL-AD) at baseline, 3 months, and 6 months 6. Capability wellbeing is measured using the ICECAP-A at baseline, 3 months, and 6 months |
| Overall study start date | 01/12/2021 |
| Overall study end date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 89 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 20; UK Sample Size: 20 |
| Participant inclusion criteria | 1. Existing diagnosis of MCI or meets screening criteria for MCI (Quick Dementia Rating System score ≥1.5 and Montreal Cognitive Assessment score ≤26) 2. Age 18-89 years (to meet the standardisation criteria of psychometric assessments) 3. Able to read and speak English to the standard necessary for completing assessment and intervention procedures 4. Able and willing to access a computer/tablet/smartphone with an internet connection throughout the study 5. Able and willing to give informed consent |
| Participant exclusion criteria | 1. Currently receiving cognitive rehabilitation 2. Previously received SMART training 3. Vision or hearing problems precluding completion of procedures 4. Unable to give informed consent 5. Diagnosis of dementia |
| Recruitment start date | 08/12/2022 |
| Recruitment end date | 30/09/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Witham Court
Fen Lane
North Hykeham
Lincoln
LN6 8UZ
United Kingdom
Sponsor information
University/education
Bridge House
Brayford Pool
Lincoln
LN6 7TS
England
United Kingdom
| Phone | +44 (0)1522853490 |
|---|---|
| sponsor@lincoln.ac.uk | |
| Website | http://www.lincoln.ac.uk/home/ |
"ROR" |
https://ror.org/03yeq9x20 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | 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? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
05/01/2023: Trial's existence confirmed by the NIHR.
