Mild cognitive impairment Mental and Behavioural Disorders
Conditions
Interventions
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 com
Sponsors
University of Lincoln
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed