Dataset Information

Computerised cognitive remediation to enhance mobility in older adults: a single-blind, single-centre, randomised trial.

ABSTRACT:

Background

Decline in executive functions and related cognitive processes is associated with mobility decline, and these functions might be amenable to cognitive remediation. This study aimed to examine whether a computerised cognitive remediation programme would improve walking in adults aged 70 years and older.

Methods

This single-blind, randomised trial at one academic centre in the USA evaluated the efficacy of an 8-week computerised programme (also known as brain games) of progressive intensity and complexity to improve walking in older adults at high-risk for mobility disability. Inclusion criteria included being 70 years or older; ambulatory; and at high-risk for mobility disability, defined using a cutscore of nine or less (frail range) on the Short Physical Performance Battery and a walking speed of 100 cm/s or less. Individuals with dementia, acute or terminal medical illnesses, recent or planned surgery affecting mobility, mobility limitations solely due to musculoskeletal limitation or pain that prevented them from completing mobility tests, and those who were nursing home residents were excluded. Participants were block randomised (1:1; block size 12 and no stratification) to the intervention group or the control group (low complexity computer games and health education classes). Primary outcomes were change in walking speed at normal pace and walking while talking conditions assessed from baseline to 8 weeks post-intervention by investigators who were masked to group assignment. Groups were compared using the intention-to-treat principle with linear mixed models adjusted for confounders. This trial was registered with ClinicalTrails.gov, NCT02567227.

Findings

Between March 1, 2016, and March 12, 2020, 383 patients were enrolled and randomly assigned to the intervention or control group. After randomisation, 11 (3%) patients were diagnosed with dementia. 372 (97%; 271 [73%] women) were included in the intention-to-treat analysis. The mean age of participants was 77·0 years [SD 5·6]). 183 (49·2%) participants were Black and 62 (16·7%) were Hispanic. 314 (93%) of the target 338 completers had finished the intervention when the trial was terminated due to the COVID-19 pandemic. Although there were significant within-group improvements in both groups after the 8-week intervention, there was no significant difference in normal walking speed (-1·03 cm/s [SD 1·30]; 95% CI -3·60 to 1·54) and walking while talking conditions (0·59 cm/s [SD 1·61]; 95% CI -2·59 to 3·76) between the intervention and control groups. Similarly, within-group, but no between-group, differences were seen on executive function tests and physical function. There were no severe adverse events related to interventions.

Interpretation

Computerised cognitive remediation improved walking in adults aged 70 years and older at high-risk for mobility disability, but improvements were not significantly greater compared with an active control. Although our findings corroborate the within-group improvements on cognition and mobility reported in previous pilot clinical trials, future studies are required to determine the optimal dose, frequency, intensity, and content of computerised cognitive remediation programmes.

Funding

National Institute on Aging.

SUBMITTER: Verghese J

PROVIDER: S-EPMC8437150 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundCognitive impairments, including delirium, are common after coronary artery bypass grafting (CABG). Improving cognition pre- and post-operatively using computerised cognitive training (CCT) may be an effective approach to improve cognitive outcomes in CABG patients.ObjectivesInvestigate the effect of remotely supervised CCT on cognitive outcomes, including delirium, in older adults undergoing CABG surgery.MethodsThirty-six participants, were analysed in a single-blinded randomised controlled trial (CCT Intervention: n = 18, Control: n = 18). CCT was completed by the intervention group pre-operatively (every other day, 45-60-minute sessions until surgery) and post-operatively, beginning 1-month post-CABG (3 x 45-60-minute sessions/week for 12-weeks), while the control group maintained usual care plus weekly phone calls. Cognitive assessments were conducted pre- and post-operatively at multiple follow-ups (discharge, 4-months and 6-months). Post-operative delirium incidence was assessed daily until discharge. Cognitive change data were calculated at each follow-up for each cognitive test (Addenbrooke's Cognitive Examination III and CANTAB; z-scored).ResultsAdherence to the CCT intervention (completion of three pre-operative or 66% of post-operative sessions) was achieved in 68% of pre-CABG and 59% of post-CABG participants. There were no statistically significant effects of CCT on any cognitive outcome, including delirium incidence.ConclusionAdherence to the CCT program was comparatively higher than previous feasibility studies, possibly due to the level of supervision and support provided (blend of face-to-face and home-based training, with support phone calls). Implementing CCT interventions both pre- and post-operatively is feasible in those undergoing CABG. No statistically significant benefits from the CCT interventions were identified for delirium or cognitive function post-CABG, likely due to the sample size available (study recruitment greatly impacted by COVID-19). It also may be the case that multimodal intervention would be more effective.

Project description:ObjectivesTo evaluate the efficacy of therapist guided internet based cognitive behavioural therapy (CBT) programme for body dysmorphic disorder (BDD-NET) compared with online supportive therapy.DesignA 12 week single blind parallel group randomised controlled trial.SettingAcademic medical centre.Participants94 self referred adult outpatients with a diagnosis of body dysmorphic disorder and a modified Yale-Brown obsessive compulsive scale (BDD-YBOCS) score of ≥ 20. Concurrent psychotropic drug treatment was permitted if the dose had been stable for at least two months before enrolment and remained unchanged during the trial.InterventionsParticipants received either BDD-NET (n=47) or supportive therapy (n=47) delivered via the internet for 12 weeks.Main outcome measuresThe primary outcome was the BDD-YBOCS score after treatment and follow-up (three and six months from baseline) as evaluated by a masked assessor. Responder status was defined as a ≥ 30% reduction in symptoms on the scale. Secondary outcomes were measures of depression (MADRS-S), global functioning (GAF), clinical global improvement (CGI-I), and quality of life (EQ5D). The six month follow-up time and all outcomes other than BDD-YBOCS and MADRS-S at 3 months were not pre-specified in the registration at clinicaltrials.gov because of an administrative error but were included in the original trial protocol approved by the regional ethics committee before the start of the trial.ResultsBDD-NET was superior to supportive therapy and was associated with significant improvements in severity of symptoms of body dysmorphic disorder (BDD-YBOCS group difference -7.1 points, 95% confidence interval -9.8 to -4.4), depression (MADRS-S group difference -4.5 points, -7.5 to -1.4), and other secondary measures. At follow-up, 56% of those receiving BDD-NET were classed as responders, compared with 13% receiving supportive therapy. The number needed to treat was 2.34 (1.71 to 4.35). Self reported satisfaction was high.ConclusionsCBT can be delivered safely via the internet to patients with body dysmorphic disorder. BDD-NET has the potential to increase access to evidence based psychiatric care for this mental disorder, in line with NICE priority recommendations. It could be particularly useful in a stepped care approach, in which general practitioner or other mental health professionals can offer treatment to people with mild to moderate symptoms at low risk of suicide.Trial registration ClinicalTrials.gov ID: NCT02010619.

Project description:IntroductionThe 1 year prevalence of depression in adolescents is about 2%. Treatment with antidepressant medication is not recommended for initial treatment in young people due to concerns over high side effects, poor efficacy and addictive potential. Evidence suggests that cognitive behaviour therapy (CBT) is an effective treatment for depression and is currently one of the main treatment options recommended in adolescents. Given the affinity young people have with information technology they may be treated effectively, more widely and earlier in their illness evolution using computer-administered CBT (CCBT). Currently little is known about the clinical and resource implications of implementing CCBT within the National Health Service for adolescents with low mood/depression. We aim to establish the feasibility of running a fully powered randomised controlled trial (RCT).Methods and analysisAdolescents aged 12-18 with low mood/depression, (scoring ≥20 on the Mood and Feelings Questionnaire (MFQ)), will be approached to participate. Consenting participants will be randomised to either a CCBT programme (Stressbusters) or accessing selected websites providing information about low mood/depression. The primary outcome measure will be the Beck Depression Inventory (BDI). Participants will also complete generic health measures (EQ5D-Y, HUI2) and resource use questionnaires to examine the feasibility of cost-effectiveness analysis. Questionnaires will be completed at baseline, 4 and 12-month follow-ups. Progress and risk will be monitored via the MFQ administered at each treatment session. The acceptability of a CCBT programme to adolescents; and the willingness of clinicians to recruit participants and of participants to be randomised, recruitment rates, attrition rates and questionnaire completion rates will be collected for feasibility analysis. We will estimate 'numbers needed' to plan a fully powered RCT of clinical and cost-effectiveness.Ethics and disseminationThe current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).Trial registration numberISRCTN31219579.