Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme
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SUBMITTER: Dark F
PROVIDER: S-EPMC7526389 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundCognitive remediation (CR) is a psychological therapy, which improves cognitive and social functioning in people with schizophrenia. It is now being implemented within routine clinical services and mechanisms of change are being explored. We designed a new generation computerised CR programme, CIRCuiTS (Computerised Interactive Remediation of Cognition - a Training for Schizophrenia), to enhance strategic and metacognitive processing, with an integrated focus on the transfer of cognitive skills to daily living. This large trial tested its feasibility to be delivered in therapist-led and independent sessions, and its efficacy for improved cognitive and social functioning.MethodsA two arm single blind randomised superiority trial comparing CIRCuiTS plus treatment-as-usual (TAU) with TAU alone in 93 people with a diagnosis of schizophrenia. Cognitive, social functioning and symptom outcomes were assessed at pre- and post-therapy and 3 months later.Results85% adhered to CIRCuiTS, completing a median of 28 sessions. There were significant improvements in visual memory at post-treatment (p = 0.009) and follow-up (p = 0.001), and a trend for improvements in executive function at post-treatment (p = 0.056) in favour of the CIRCuiTS group. Community function was also differentially and significantly improved in the CIRCuiTS group at post-treatment (p = 0.003) but not follow-up, and was specifically predicted by improved executive functions.ConclusionsCIRCuiTS was beneficial for improving memory and social functioning. Improved executive functioning emerges as a consistent predictor of functional gains and should be considered an important CR target to achieve functional change. A larger-scale effectiveness trial of CIRCuiTS is now indicated.
| S-EPMC5647677 | biostudies-literature
Project description:BackgroundDecline 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.MethodsThis 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.FindingsBetween 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.InterpretationComputerised 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.FundingNational Institute on Aging.
| S-EPMC8437150 | biostudies-literature
Project description:Treatments for the cognitive impairments of schizophrenia are urgently needed. We developed and tested a 12-week, group-based, manualized, compensatory cognitive training intervention targeting prospective memory, attention, learning/memory, and executive functioning. The intervention focused on compensatory strategies, such as calendar use, self-talk, note taking, and a 6-step problem-solving method, and did not require computers.In a randomized controlled trial, 69 outpatients with DSM-IV primary psychotic disorders were assigned to receive standard pharmacotherapy alone or compensatory cognitive training + standard pharmacotherapy for 12 weeks. Assessments of neuropsychological performance and functional capacity (primary outcomes) and psychiatric symptom severity, quality of life, social skills performance, cognitive insight, and self-reported everyday functioning (secondary outcomes) were administered at baseline, posttreatment, and 3-month follow-up. Data were collected between September 2003 and August 2009.Hierarchical linear modeling analyses demonstrated significant compensatory cognitive training-associated effects on attention at follow-up (P = .049), verbal memory at posttreatment and follow-up (P values ? .039), and functional capacity (University of California, San Diego Performance-based Skills Assessment) at follow-up (P = .004). The compensatory cognitive training group also differentially improved in negative symptom severity at posttreatment and follow-up (P values ? .025) and subjective quality of life at follow-up (P = .002).Compensatory cognitive training, a low-tech, brief intervention, has the potential to improve not only cognitive performance but also functional skills, negative symptoms, and self-rated quality of life in people with psychosis.ClinicalTrials.gov identifier: NCT01521026.
| S-EPMC3593661 | biostudies-literature
Project description:The 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).Adolescents 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.The current trial protocol received a favourable ethical opinion from Leeds (West) Research and Ethics Committee. (Reference: 10/H1307/137).ISRCTN31219579.
| S-EPMC4216856 | biostudies-other
Project description:INTRODUCTION:Coronary artery bypass grafting (CABG) surgery is known to improve vascular function and cardiac-related mortality rates; however, it is associated with high rates of postoperative cognitive decline and delirium. Previous attempts to prevent post-CABG cognitive decline using pharmacological and surgical approaches have been largely unsuccessful. Cognitive prehabilitation and rehabilitation are a viable yet untested option for CABG patients. We aim to investigate the effects of preoperative cognitive training on delirium incidence, and preoperative and postoperative cognitive training on cognitive decline at 4 months post-CABG. METHODS AND ANALYSIS:This study is a randomised, single-blinded, controlled trial investigating the use of computerised cognitive training (CCT) both pre-CABG and post-CABG (intervention group) compared with usual care (control group) in older adults undergoing CABG in Adelaide, South Australia. Those in the intervention group will complete 1-2 weeks of CCT preoperatively (45-60?min sessions, 3.5 sessions/week) and 12 weeks of CCT postoperatively (commencing 1?month following surgery, 45-60?min sessions, 3 sessions/week). All participants will undergo cognitive testing preoperatively, over their hospital stay including delirium, and postoperatively for up to 1?year. The primary delirium outcome variable will be delirium incidence (presence vs absence); the primary cognitive decline variable will be at 4?months (significant decline vs no significant decline/improvement from baseline). Logistic regression modelling will be used, with age and gender as covariates. Secondary outcomes include cognitive decline from baseline to discharge, and at 6?months and 1?year post-CABG. ETHICS AND DISSEMINATION:Ethics approval was obtained from the Central Adelaide Local Health Network Human Research Ethics Committee (South Australia, Australia) and the University of South Australia Human Ethics Committee, with original approval obtained on 13 December 2017. It is anticipated that approximately two to four publications and multiple conference presentations (national and international) will result from this research. TRIAL REGISTRATION NUMBER:This clinical trial is registered with the Australian New Zealand Clinical Trials Registry and relates to the pre-results stage. Registration number: ACTRN12618000799257.
| S-EPMC7045123 | biostudies-literature
Project description:IntroductionPeople with mild cognitive impairment (MCI) are at increased risk of decreasing cognitive functioning. Computerised cognitive training (CCT) and nutrition have been shown to improve the cognitive capacities of people with MCI. For each variable, we developed two kinds of interventions specialised for people with MCI (CCT: 'individualised' CCT; nutrition: a whole-food, plant-based diet). Additionally, there are two kinds of active control measures (CCT: 'basic' CCT; nutrition: a healthy diet following the current guidelines of the German Nutrition Society). The aim of this study is to investigate the effects of the two interventions on cognition in people with MCI in a 2×2 randomised controlled trial with German participants.Methods and analysisParticipants will be community-dwelling individuals with a psychometric diagnosis of MCI based on the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination. With N=200, effects with an effect size of f≥0.24 (comparable to Cohen's d≥0.48) can be detected. Screening, baseline, t6 and t12 testing will be conducted via a videoconferencing assessment, telephone, and online survey. Participants will be randomly allocated to one of four groups and will receive a combination of CCT and online nutritional counselling. The CCT can be carried out independently at home on a computer, laptop, or tablet. Nutrition counselling includes 12 online group sessions every fortnight for 1.5 hours. The treatment phase is 6 months with follow-ups after six and 12 months after baseline.Ethics and disseminationAll procedures were approved by the Friedrich-Alexander-Universität Erlangen-Nürnberg Ethics Committee (Ref. 21-318-1-B). Written informed consent will be obtained from all participants. Results will be published in peer-reviewed scientific journals, conference presentations.Trial registration numberISRCTN10560738.
| S-EPMC9252202 | biostudies-literature
Project description:This study examined the efficacy of an integrative cognitive remediation program (REHACOP) in improving cognition and functional outcome in patients with schizophrenia. The program combines cognitive remediation, social cognitive intervention, and functional skills training. Few studies have attempted this approach. One hundred and eleven patients diagnosed with schizophrenia were randomly assigned to either the cognitive remediation group (REHACOP) or an active control group (occupational activities) for 4 months (three sessions per week, 90?min). Primary outcomes were change on general neurocognitive performance and social cognition, including theory of mind (ToM), emotion perception (EP), attributional style, and social perception (SP). Secondary outcomes included changes on clinical symptoms (Positive and Negative Syndrome Scale) and functional outcome (UCSD Performance-Based Skills Assessment and the Global Assessment of Functioning). The trial was registered with clinicaltrials.gov (NCT02796417). No baseline group differences were found. Significant differences were found in the mean change between the REHACOP group and control group in neurocognition ([Formula: see text]), SP ([Formula: see text]), ToM ([Formula: see text]), EP ([Formula: see text]), negative symptoms ([Formula: see text]), emotional distress ([Formula: see text]), Global Assessment of Functioning ([Formula: see text]), and UCSD Performance-Based Skills Assessment ([Formula: see text]). The combination of cognitive remediation, social cognitive intervention, and functional skills training demonstrated statistically significant and clinically meaningful changes in neurocognition, social cognition, negative, and functional disability.
| S-EPMC5102241 | biostudies-literature
Project description:Study questionHow effective is supported computerised cognitive behaviour therapy (cCBT) as an adjunct to usual primary care for adults with depression?MethodsThis was a pragmatic, multicentre, three arm, parallel randomised controlled trial with simple randomisation. Treatment allocation was not blinded. Participants were adults with symptoms of depression (score ≥ 10 on nine item patient health questionnaire, PHQ-9) who were randomised to receive a commercially produced cCBT programme ("Beating the Blues") or a free to use cCBT programme (MoodGYM) in addition to usual GP care. Participants were supported and encouraged to complete the programme via weekly telephone calls. Control participants were offered usual GP care, with no constraints on the range of treatments that could be accessed. The primary outcome was severity of depression assessed with the PHQ-9 at four months. Secondary outcomes included health related quality of life (measured by SF-36) and psychological wellbeing (measured by CORE-OM) at four, 12, and 24 months and depression at 12 and 24 months.Study answer and limitationsParticipants offered commercial or free to use cCBT experienced no additional improvement in depression compared with usual GP care at four months (odds ratio 1.19 (95% confidence interval 0.75 to 1.88) for Beating the Blues v usual GP care; 0.98 (0.62 to 1.56) for MoodGYM v usual GP care). There was no evidence of an overall difference between either programme compared with usual GP care (0.99 (0.57 to 1.70) and 0.68 (0.42 to 1.10), respectively) at any time point. Commercially provided cCBT conferred no additional benefit over free to use cCBT or usual GP care at any follow-up point. Uptake and use of cCBT was low, despite regular telephone support. Nearly a quarter of participants (24%) had dropped out by four months. The study did not have enough power to detect small differences so these cannot be ruled out. Findings cannot be generalised to cCBT offered with a much higher level of guidance and support.What this study addsSupported cCBT does not substantially improve depression outcomes compared with usual GP care alone. In this study, neither a commercially available nor free to use computerised CBT intervention was superior to usual GP care.Funding, competing interests, data sharingCommissioned and funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project No 06/43/05). The authors have no competing interests. Requests for patient level data will be considered by the REEACT trial management groupTrial registration Current Controlled Trials ISRCTN91947481.
| S-EPMC4641883 | biostudies-literature
Project description:IntroductionA broad range of mental disorders are now understood as aberrations of normal adolescent brain development. In both adolescents and adults, executive dysfunction has been implicated across a range of mental illnesses, and enhancing executive functioning may prove to be a useful prevention strategy for adolescents at risk for a range of psychopathology.Methods and analysisThis study will consist of a double-blind, randomised controlled trial with a 12-month follow-up period. Participants will consist of 200 people aged 16-24?years who are at risk for a range of mental disorders based on personality risk factors, but have not experienced a lifetime mental illness as determined by a structured diagnostic interview. Participants will be randomly allocated to either an intervention group who complete an online cognitive training programme specifically targeting executive functioning ability or a control group who complete an online cognitive training programme that has limited executive functioning training potential. Superiority of the executive functioning training programme compared with the control training programme will be assessed at baseline, post-training and at 3-month, 6-month and 12-month follow-up. All assessments will be conducted online. The primary outcome of the study will be general psychopathology as measured by the Strengths and Difficulties Questionnaire. Secondary outcomes will include executive functioning ability, day-to-day functioning and alcohol consumption. All analyses will be undertaken using mixed-model repeated measures analysis of variance with planned contrasts.Ethics and disseminationEthics approval has been obtained from the University of New South Wales Human Research Ethics Committee (HC15094). Results of the trial immediately post-treatment and at 12?months follow-up will be submitted for publication in peer-reviewed journals.Trial registration numberACTRN12616000127404; Pre-results.
| S-EPMC5623502 | biostudies-literature
Project description:Abstract Background Cognitive remediation (CR) and physical exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact on daily functionality is still limited. Physical exercise increases Brain Derived Neurotrophic Factor (BDNF) levels, promoting neuronal and cognitive plasticity, which can maximize the impact of CR. We are conducting a randomised controlled trial to determine the efficacy of an intensive program that combines CR and physical exercise on cognition and related outcomes for patients with schizophrenia. In addition, we investigate functional and structural brain effects of this intervention and its association to BDNF. Methods This study protocol describes a randomized controlled trial in which 74 patients are randomly assigned to either CR and physical exercise or CR and health promotion. The interventions are 12-week long and consist of three weekly sessions (90min of CR and 40min of either aerobic exercise or health promotion). To be included in the study, patients must be diagnosed with schizophrenia or schizoaffective disorder, aged 28–60 years, and do low physical activity, as measured by International Physical Activity Questionnaire, IPAQ. Exclusion Criteria for participation in the study are the presence of neurological or substance use disorders, IQ < 70 and somatic illnesses that contraindicate physical exercise. Healthy control participants (n=18) are screened for the presence of lifetime Axis I psychotic disorders and for the presence of a first-degree relative with schizophrenia. Primary outcome measures are cognitive performance, functional outcome, negative symptoms, BDNF levels and neuroimaging measures. Secondary outcome measures are quality of life and metabolic parameters. All measures are blindly assessed at baseline, at 3 months follow up and at 15 months follow up. This trial was approved by the Comité Ètic d’Investigació Clínica de l’Hospital del Mar (CEIC) 2015/6209/I Results This poster is a study protocol. We will correct data from now on. Discussion The results of this trial will provide valuable information about whether cognitive remediation efficacy for patients with schizophrenia can be enhanced by aerobic exercise-induced BDNF upregulation. TRIAL REGISTRATION The trial is registered at www.clinicaltrials.gov (NCT02864576)
| S-EPMC5887596 | biostudies-literature