INTERVENTION COMPARATIVE EFFECTIVENESS FOR ADULT COGNITIVE TRAINING (ICE-ACT) (CLINICALTRIALS#:NCT03141281)
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ABSTRACT:
SUBMITTER: Yoon J
PROVIDER: S-EPMC6239819 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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Project description:Age-related perceptual and cognitive declines are associated with difficulties performing everyday tasks required to remain independent. Encouraging improvements in cognitive abilities have been shown for various short-term interventions but there is little evidence for direct impact on independence. This project compares the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance. Participants (N = 230, Mean age = 72) were randomly assigned to one of four training conditions: broad training using either (1) a web-based brain game suite, Brain HQ, or (2) a strategy video game, Rise of Nations, or to directed training for (3) Instrumental Activities of Daily Living (IADL) training using web-based programs for both driving and fraud avoidance training, or (4) to an active control condition of puzzle solving. Training took approximately 15-20 h for each intervention condition across four weeks. Before training began, participants received baseline ability tests of perception, attention, memory, cognition, and IADL, including a driving simulator test for hazard perception, and a financial fraud recognition test. They were tested again on these measures following training completion (post-test). A one-year follow-up from training completion is also scheduled. The baseline results support that randomization was successful across the intervention conditions. We discuss challenges and potential solutions for using technology-based interventions with older adults. We also discuss how the current trial addressed methodological limitations of previous intervention studies. TRIAL REGISTRATION NUMBER: NCT03141281.
| S-EPMC6485952 | biostudies-literature
Project description:BackgroundSchizophrenia and related disorders are highly disabling and create substantial burdens for families, communities, and health care systems. Although pharmacological treatments can often lessen the psychotic symptoms that are a hallmark of schizophrenia, they do not lessen the social and cognitive deficits that create the greatest impediments to community engagement and functional recovery. This study builds on prior research on psychosocial rehabilitation by comparing the effectiveness of two treatments demonstrated as efficacious in improving social and community functioning, Cognitive Enhancement Therapy (CET) and a version of Social Skills Training (HOPES/SST).MethodsThe study uses a randomized cluster design in which a pair of clinicians at community- and hospital-based mental service centers deliver either CET or HOPES to at least one group of 6-8 eligible clients for 12 months. Clinicians are trained and then supervised weekly, with ongoing process measurement of treatment fidelity, attendance, satisfaction, and retention, and use of other services. Measures administered at baseline and at 6 and 12 months while in treatment, and then at 18 and 24 months after treatment include social adjustment, quality of life, social skills, positive and negative symptoms, and neuro- and social cognition. We hypothesize that CET will be associated with greater improvements than SST in both the primary outcome of community functioning and the secondary outcomes of neuro- and social cognition and social skills. Secondarily, we hypothesize that more cognitive impairment at baseline and younger age will predict more benefit from CET compared to HOPES.DiscussionResource shortages endemic in mental health services and exacerbated by the pandemic highlight the importance of identifying the most effective approach to improving social and community functioning. We aim to improve understanding of the impact of two efficacious psychosocial treatments and to improve clinicians' ability to refer to both treatments the individuals who are most likely to benefit from them. We expect the result to be programmatic improvements that improve the magnitude and durability of gains in community functioning.Trial registrationClinicalTrial.gov NCT04321759 , registered March 25, 2020.
| S-EPMC9434502 | biostudies-literature
Project description:BackgroundAdults over age 65 represent the fastest growing population in the US. Decline in cognitive abilities is a hallmark of advanced age and is associated with loss of independence and dementia risk. There is a pressing need to develop effective interventions for slowing or reversing the cognitive aging process. While certain forms of cognitive training have shown promise in this area, effects only sometimes transfer to neuropsychological tests within or outside the trained domain. This paper describes a NIA-funded Phase III adaptive multisite randomized clinical trial, examining whether transcranial direct current stimulation (tDCS) of frontal cortices enhances neurocognitive outcomes achieved from cognitive training in older adults experiencing age-related cognitive decline: the Augmenting Cognitive Training in Older Adults study (ACT).MethodsACT will enroll 360 participants aged 65 to 89 with age-related cognitive decline, but not dementia. Participants will undergo cognitive training intervention or education training-control combined with tDCS or sham tDCS control. Cognitive training employs a suite of eight adaptive training tasks focused on attention/speed of processing and working memory from Posit Science BrainHQ. Training control involves exposure to educational nature/history videos and related content questions of the same interval/duration as the cognitive training. Participants are assessed at baseline, after training (12weeks), and 12-month follow-up on our primary outcome measure, NIH Toolbox Fluid Cognition Composite Score, as well as a comprehensive neurocognitive, functional, clinical and multimodal neuroimaging battery.SignificanceThe findings from this study have the potential to significantly enhance efforts to ameliorate cognitive aging and slow dementia.
| S-EPMC5803439 | biostudies-literature
Project description:BackgroundDeveloping non-pharmacological interventions with strong potential to prevent or delay the onset of Alzheimer's disease (AD) in high-risk populations is critical. Aerobic exercise and cognitive training are two promising interventions. Aerobic exercise increases aerobic fitness, which in turn improves brain structure and function, while cognitive training improves selective brain function intensively. Hence, combined aerobic exercise and cognitive training may have a synergistic effect on cognition by complementary strengthening of different neural functions. Few studies have tested the effects of such a combined intervention, and the findings have been discrepant, largely due to varying doses and formats of the interventions.Methods/designThe purpose of this single-blinded, 2 × 2 factorial phase II randomized controlled trial is to test the efficacy and synergistic effects of a 6-month combined cycling and speed of processing training intervention on cognition and relevant mechanisms (aerobic fitness, cortical thickness, and functional connectivity in the default mode network) in older adults with amnestic mild cognitive impairment. This trial will randomize 128 participants equally to four arms: cycling and speed of processing, cycling only, speed of processing only, or attention control for 6 months, and then follow them for another 12 months. Cognition and aerobic fitness will be assessed at baseline and at 3, 6, 12, and 18 months; cortical thickness and functional connectivity at baseline and at 6, 12, and 18 months; Alzheimer's disease (AD) conversion at 6, 12, and 18 months. The specific aims are to (1) determine the efficacy and synergistic effects of the combined intervention on cognition over 6 months, (2) examine the underlying mechanisms of the combined intervention, and (3) calculate the long-term effect sizes of the combined intervention on cognition and AD conversion. The analysis will use intention-to-treat and linear mixed-effects modeling.DiscussionThis trial will be among the first to test the synergistic effects on cognition and mechanisms (relevant to Alzheimer's-associated neurodegeneration) of a uniquely conceptualized and rigorously designed aerobic exercise and cognitive training intervention in older adults with mild cognitive impairment. It will advance Alzheimer's prevention research by providing precise effect-size estimates of the combined intervention.Trial registrationClinicalTrials.gov, NCT03313895 . Registered on 18 October 2017.
| S-EPMC6303946 | biostudies-literature
Project description:Autism is defined by persistent deficits in social communication and social interaction in multiple contexts as well as restricted and repetitive patterns of behavior. There are also reported difficulties in the dynamic activation and modification of cognitive processes in response to changes in tasks' demands. Such difficulties are believed to be due to poor flexible cognition. This research aimed to assess and intervene in cognitive flexibility in subjects with autism.Ten subjects diagnosed with autism by psychiatrists, aged 5 years to 13 years and 5 months, were assessed in non-verbal intelligence through Raven's Progressive Matrices in pretest. They were also assessed in cognitive flexibility through Wisconsin Card Sorting Test (WCST) and in patterns of social interactions, behaviors, and communication through Autism Diagnostic Interview-Revised (ADI-R). An intervention program of 14 to 21 sessions was established to enhance cognitive flexibility. In posttest, they were assessed in WCST and ADI-R.All measures of cognitive flexibility improved in posttest except for failure to maintain set. Among the measures improved in posttest, perseverative errors and responses improved in posttest with statistical significance as well as categories completed. Total scores on ADI-R were lower in posttest as well as scores on communication abilities.The qualitative improvement showed by the individuals of this research concerning cognitive flexibility and also patterns of restricted behavior, social interaction, and communication abilities suggests that individuals with autism can benefit from the development of strategies for the enhancement of cognitive flexibility. Nevertheless, more research is suggested with a larger sample among subjects on the autism spectrum.
| S-EPMC6974343 | biostudies-literature
Project description:IntroductionAlthough the Diabetes Prevention Program and other clinical trials demonstrated the efficacy of intensive lifestyle interventions (ILI) and metformin to prevent type 2 diabetes, no studies have tested their comparative effects in pragmatic settings. This study was designed to compare the real-world effectiveness of ILI, metformin, and standard care among Hispanic women (Latinas) with prediabetes.Study designRCT.Setting/participantsNinety-two Latinas, who had a mean hemoglobin A1c of 5.9%, BMI of 33.3 kg/m2, and waist circumference of 97.4 cm (38.3 inches), were recruited from an urban community and randomly assigned to ILI, metformin, or standard care using 1:1:1 allocation. Data were collected from 2013-2015 and analyzed in 2016.InterventionThe 12-month ILI was adapted from the Diabetes Prevention Program's ILI and delivered by community health workers (promotoras) over 24 sessions. Metformin participants received 850 mg twice daily. Those randomized to standard care continued their regular medical care.Main outcome measuresWeight and secondary outcomes (waist circumference, blood pressure, hemoglobin A1c, fasting plasma glucose, insulin, and lipids) were assessed at baseline and 12 months.ResultsILI participants demonstrated significantly greater mean weight loss (-4.0 kg, 5.0%) than metformin (-0.9 kg, 1.1%) and standard care participants (+0.8 kg, 0.9%) (p<0.001). The difference in weight loss between metformin and standard care was not significant. The ILI group experienced a greater reduction in waist circumference than standard care (p=0.001), and a marginal improvement in hemoglobin A1c compared with metformin and standard care (p=0.063).ConclusionsIn the first comparative effectiveness trial of diabetes prevention treatments, a 12-month ILI produced significantly greater weight loss than metformin and standard care among Latinas with prediabetes. These data suggest that ILI delivered by promotoras is an effective strategy for preventing diabetes in this high-risk group, which may be superior to metformin. Future pragmatic trials involving larger samples should examine differences in diabetes incidence associated with these treatments.
| S-EPMC5438762 | biostudies-literature
Project description:The current study examined the feasibility and acceptability of an integrated Cognitive-Behavioral Social Skills Training and Compensatory Cognitive Training (CBSST-CCT) intervention compared with Goal-Focused Supportive Contact (SC) in a pilot randomized controlled trial for people with schizophrenia with high negative symptom severity. The sample included 55 participants from five community settings; masters-level study clinicians delivered interventions on-site. Participants completed assessments of cognitive, functional, and psychiatric symptoms at baseline, mid-treatment, post-treatment (12.5 weeks), and 6-month follow-up. Enrollment goals were not initially met, necessitating the addition of a fifth site; however, all groups and assessments were completed on-site. Study procedures were acceptable, as evidenced by 100% enrollment and completion of baseline assessments following informed consent; however, over 1/3rd of participants dropped out. No modifications were necessary to the intervention procedures and CBSST-CCT fidelity ratings were acceptable. The intervention was deemed acceptable among participants who attended ≥1 session, as evidenced by similar attendance rates in CBSST-CCT compared to SC. Among CBSST-CCT participants, lower positive symptoms were significantly associated with better attendance. Overall, we found mixed evidence for the feasibility and acceptability of the CBSST-CCT protocol in people with schizophrenia with high negative symptoms. Challenges are highlighted and recommendations for future investigations are provided.
| S-EPMC7779756 | biostudies-literature
Project description:BackgroundVirtual reality (VR) technology has become increasingly used for assessment and intervention in the neuroscience field.ObjectiveWe aimed to investigate the effects of a VR Training System, named VRADA (VR Exercise App for Dementia and Alzheimer's Patients), on the cognitive functioning of older people with mild cognitive impairment (MCI).MethodsIn this intervention study, 122 older adults with MCI were randomly assigned to five groups (the VRADA group (n = 28), a bike group (n = 11), a physical exercise group (n = 24), a mixed group (physical and cognitive exercise) (n = 31), and a non-contact control group (n = 28). The VRADA group underwent 32 physical and cognitive training sessions, performed 2 or 3 times weekly for 12 weeks in the VR environment. All participants had detailed neuropsychological assessments before and after intervention.ResultsA series of linear regression models revealed that the VRADA group showed improvement or no deterioration in cognitive decline in global cognitive function (MMSE), verbal memory (Rey Auditory Verbal Learning Test and WAIS forward test), and executive functions, mental flexibility (Trail Making Test B).ConclusionsThis interventionstudy indicates that the VRADA system improves the cognitive function of elders with MCI.
| S-EPMC10789285 | biostudies-literature
Project description:Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands. However, this evidence also showed that not all children included in the intervention groups equally increased their performance levels, which could be related to individual and contextual variability. The present study aimed to explore the impact of a computerized cognitive training intervention with lab-based tasks in preschoolers from Unsatisfied Basic Needs (UBN) homes under the consideration of their baseline performance. In the context of a randomized controlled trial design, different interventions were administered to children according to their baseline performance in a variety of cognitive tasks (i.e., executive attention, inhibitory control, working memory, and planning demands). The results showed different patterns of impact on performance depending on the experimental group, supporting the importance of considering individual and contextual differences in the design of interventions aimed at optimizing executive functions in poverty-impacted sample populations in early stages of development.
| S-EPMC7215356 | biostudies-literature
Project description:Studies suggest that people suffering from chronic pain may have altered brain plasticity, along with altered functional connectivity between pain-processing brain regions. These may be related to decreased mood and cognitive performance. There is some debate as to whether physical activity combined with behavioral therapy (e.g. cognitive distraction, body scan) may counteract these changes. However, underlying neuronal mechanisms are unclear. The aim of the current pilot study with a 3-armed randomized controlled trial design was to examine the effects of sensorimotor training for nonspecific chronic low back pain on (1) cognitive performance; (2) fMRI activity co-fluctuations (functional connectivity) between pain-related brain regions; and (3) the relationship between functional connectivity and subjective variables (pain and depression). Six hundred and sixty two volunteers with non-specific chronic low back pain were randomly allocated to a unimodal (sensorimotor training), multidisciplinary (sensorimotor training and behavioral therapy) intervention, or to a control group within a multicenter study. A subsample of patients (n = 21) from one study center participated in the pilot study presented here. Measurements were at baseline, during (3 weeks, M2) and after intervention (12 weeks, M4 and 24 weeks, M5). Cognitive performance was measured by the Trail Making Test and functional connectivity by MRI. Pain perception and depression were assessed by the Von Korff questionnaire and the Hospital and Anxiety. Group differences were calculated by univariate and repeated ANOVA measures and Bayesian statistics; correlations by Pearson's r. Change and correlation of functional connection were analyzed within a pooled intervention group (uni-, multidisciplinary group). Results revealed that participants with increased pain intensity at baseline showed higher functional connectivity between pain-related brain areas used as ROIs in this study. Though small sample sizes limit generalization, cognitive performance increased in the multimodal group. Increased functional connectivity was observed in participants with increased pain ratings. Pain ratings and connectivity in pain-related brain regions decreased after the intervention. The results provide preliminary indication that intervention effects can potentially be achieved on the cognitive and neuronal level. The intervention may be suitable for therapy and prevention of non-specific chronic low back pain.
| S-EPMC9393784 | biostudies-literature