scholarly journals Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Frances Dark ◽  
Ellie Newman ◽  
Victoria Gore-Jones ◽  
Veronica De Monte ◽  
Marta I. Garrido ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Cognitive Training ◽  
Controlled Trial ◽  
Schizophrenia Spectrum Disorders ◽  
Cognitive Interventions ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders ◽  
Randomised Controlled

Abstract Background Compensation and adaptation therapies have been developed to improve community functioning via improving neurocognitive abilities in people with schizophrenia. Various modes of delivering compensation and adaptation therapies have been found to be effective. The aim of this trial is to compare two different cognitive interventions, Compensatory Cognitive Training (CCT) and Computerised Interactive Remediation of Cognition–Training for Schizophrenia (CIRCuiTS). The trial also aims to identify if mismatch negativity (MMN) can predict an individual’s response to the compensation and adaptation programmes. Methods This study will use a randomised, controlled trial of two cognitive interventions to compare the impact of these programmes on measures of neurocognition and function. One hundred clinically stable patients aged between 18 and 65 years with a diagnosis of a schizophrenia spectrum disorder will be recruited. Participants will be randomised to either the CCT or the CIRCuiTS therapy groups. The outcome measures are neurocognition (BACS), subjective sense of cognitive impairment (SSTICS), social functioning (SFS), and MMN (measured by EEG) in people with schizophrenia spectrum disorders. Discussion This trial will determine whether different approaches to addressing the cognitive deficits found in schizophrenia spectrum disorders are of comparable benefit using the outcome measures chosen. This has implications for services where cost and lack of computer technology limit the implementation and dissemination of interventions to address cognitive impairment in routine practice. The trial will contribute to the emerging evidence of MMN as a predictor of response to cognitive interventions. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000161224. Registered on 2 February 2018. Protocol version: 4.0, 18 June 2018.

Computerised Cognitive Training for Older Persons With Mild Cognitive Impairment: A Pilot Study Using a Randomised Controlled Trial Design

2011 ◽  
Vol 12 (3) ◽  
pp. 187-199 ◽  
Author(s):  
Maurice Finn ◽  
Skye McDonald
Keyword(s):  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Cognitive Training ◽  
Visual Memory ◽  
Controlled Trial ◽  
Future Research ◽  
Neuropsychological Measures ◽  
Memory Functioning ◽  
Randomised Controlled

AbstractThe results of a pilot randomised controlled trial of computerised cognitive training in older adults with mild cognitive impairment (MCI) are reported. Participants (N = 25) were randomised into either the treatment or waitlist training groups. Sixteen participants completed the 30-session computerised cognitive training program using exercises that target a range of cognitive functions including attention, processing speed, visual memory and executive functions. It was hypothesised that participants would improve with practice on the trained tasks, that the benefits of training would generalise to nontrained neuropsychological measures, and that training would result in improved perceptions of memory and memory functioning when compared with waitlist controls. Results indicated that participants were able to improve their performance across a range of tasks with training. There was some evidence of generalisation of training to a measure of visual sustained attention. There were no significant effects of training on self-reported everyday memory functioning or mood. The results are discussed along with suggestions for future research.

scholarly journals A Systematic Review of Non-pharmacological Strategies to Reduce the Risk of Violence in Patients With Schizophrenia Spectrum Disorders in Forensic Settings

2021 ◽  
Vol 12 ◽  
Author(s):  
Rudolf Slamanig ◽  
Andreas Reisegger ◽  
Hildegard Winkler ◽  
Giovanni de Girolamo ◽  
Giuseppe Carrà ◽  
...  
Keyword(s):  
Systematic Review ◽  
Outcome Measures ◽  
Behavioral Treatment ◽  
Controlled Trial ◽  
Schizophrenia Spectrum Disorders ◽  
Sample Sizes ◽  
Pharmacological Interventions ◽  
Randomized Controlled ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders

Background: The purpose of this systematic review is to systematically investigate which non-pharmacological interventions are effective in reducing violence risk among patients with schizophrenia spectrum disorders (SSD) in forensic settings.Methods: Six electronic data bases were searched. Two researchers independently screened 6,003 abstracts resulting in 143 potential papers. These were analyzed in detail by two independent researchers yielding 10 articles that could be used.Results: Of the 10 articles, four were non-randomized controlled trials, three were pre-post studies without controls, and one was observational. Only two studies applied a randomized controlled trial design. Cognitive behavioral treatment programs were investigated in three studies. A broad range of other interventions were studied. Often outcome measures were specific to each study and sample sizes were small. Frequently, important methodological information was missing from the papers. It was not possible to carry out a meta-analysis due to the heterogeneity of the study designs and outcome measures.Conclusion: Because of methodological limitations it is difficult to draw firm conclusions about the effectiveness of non-pharmacological interventions to reduce the risk of violence in patents with SSD in forensic psychiatry settings. Studies applying better methods in terms of study design, sample sizes and outcome measures are urgently needed.

scholarly journals S41. RANDOMISED CONTROLLED TRIAL OF METACOGNITIVE TRAINING COMPARED WITH PSYCHOEDUCATION IN PATIENTS WITH SCHIZOPHRENIA SPECTRUM DISORDERS: EFFECTS ON INSIGHT

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S47-S48
Author(s):  
Javier-David Lopez-Morinigo ◽  
Adela Sánchez Escribano-Martínez ◽  
Verónica González Ruiz-Ruano ◽  
Laura Mata-Iturralde ◽  
Sergio Sánchez-Alonso ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Schizophrenia Spectrum Disorders ◽  
Metacognitive Training ◽  
Cognitive Insight ◽  
Schizophrenia Spectrum ◽  
Spectrum Disorders ◽  
Randomised Controlled

Abstract Background Insight in schizophrenia spectrum disorders (SSD) has been linked with positive outcomes. However, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight in SSD has led to speculation that metacognitive training (MCT) may improve insight and clinical outcomes in SSD. Methods Design: Single-center, assessor-blind, parallel-group, randomised controlled trial (RCT). Sample: Participants are recruited from the outpatient clinic of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) over June-December 2019. Inclusion criteria: i) age: 18–64 years, both inclusive, at the study inception; ii) diagnosis: SSD based on the Mini International Neuropsychiatric Interview (Sheehan et al., 1998) and iii) IQ>70 according to the Wechsler Adults Intelligence Scale-IV (Wechsler, 1981). Those with organic and drugs-induced psychosis, poor level of Spanish and/or lack of cooperativeness are excluded. Intervention: Participants are randomised to receive eight weekly group sessions of MCT or group psychoeducation (PSE) and they will be assessed at: T0) at baseline; T1) after treatment and T2) at 1-year follow-up, although follow-up data are not available yet. Co-primary outcome measures: clinical and cognitive insight dimensions, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) (Kemp & David, 1997), and the Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004), respectively. Secondary outcome measures: i)Symptom severity-Positive and Negative Syndrome Scale (Kay et al., 1987); ii)Functioning-General Assessment of Functioning (Endicott et al., 1976), World Health Organization Disability Scale (WHO, 2012) and Satisfaction Life Domains Scale (Carlson et al., 2009), and only at follow-up (T2) iii)Suicidal Behaviour and iv) Hospitalizations. Power calculations: To reach a power of β=80% and detect a between-group difference of two points on the SAI-E total scores, which is considered to be clinically meaningful -effect size of 0.33-, the estimated sample size at the end of the study is n=126. Statistics: Student’s T-test and Mann-Whitney U tests were used as appropriate to compare between-group differences before- and after-treatment, i.e., the changes from baseline to post-treatment scores. The protocol of the study is registered at ClinicalTrials.gov (NCT04104347). Results n=49 subjects have been assessed at baseline so far (26 males, age: 47.0±10.2 years, diagnosis of schizophrenia -F20-ICD10-, n=36, 73.5%). Fifteen individuals (MCT: n=8; controls: n=7) have completed the treatment and the post-treatment assessment (T1). ‘After-treatment-T1 - baseline-T0’ scores difference means/medians between-group differences (MCT vs. PSE) were: SAI-E total insight 1.00 vs. -2.00, p=0.050; SAI-E illness awareness 0.62±2.20 vs. -0.43±1.62, p=0.316; SAI-E symptom relabelling 0.37±3.38 vs. -1.86±2.34, p=0.167; SAI-E treatment compliance 0.00 vs. 0.00, p>0.05,ns; BCIS self-reflectiveness 0.50±3.78 vs. -1.43±2.22, p=0.259, BCIS self-certainty 1.62±2.97 vs. 0.00±2.44, p=0.298 and BCIS Composite Index -1.13±5.62 vs. -2.17±3.49, p=0.698. Discussion This is the first RCT testing the effect of group MCT on insight (as primary outcome) in a sample of unselected patients with SSD in comparison with psychoeducation. Two main findings emerged from the results. First, MCT appears to improve clinical and cognitive insight in SSD. Second, MCT was shown to be superior to PSE in changing insight. Whether the above MCT-related insight improvement is maintained at longer-term and whether this has an impact on clinical and social outcomes are yet to be established, which will be properly looked at in this trial.

scholarly journals Feasibility of 3-month melatonin supplementation for brain oxidative stress and sleep in mild cognitive impairment: protocol for a randomised, placebo-controlled study

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041500
Author(s):  
Zoe Menczel Schrire ◽  
Craig L Phillips ◽  
Shantel L Duffy ◽  
Nathaniel S Marshall ◽  
Loren Mowszowski ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Blood Pressure ◽  
Cognitive Impairment ◽  
Mild Cognitive Impairment ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Controlled Study ◽  
Brain Oxidative Stress ◽  
Randomised Controlled

IntroductionMelatonin has multiple proposed therapeutic benefits including antioxidant properties, synchronisation of the circadian system and lowering of blood pressure. In this protocol, we outline a randomised controlled trial to assess the feasibility, acceptability and tolerability of higher dose (25 mg) melatonin to target brain oxidative stress and sleep disturbance in older adults with mild cognitive impairment (MCI).Methods and analysisThe study design is a randomised double-blind, placebo-controlled, parallel group trial. Forty individuals with MCI will be recruited from the Healthy Brain Ageing Clinic, University of Sydney and from the community, and randomised to receive either 25 mg oral melatonin or placebo nightly for 12 weeks. The primary outcomes are feasibility of recruitment, acceptability of intervention and adherence to trial medication at 12 weeks. Secondary outcomes will include the effect of melatonin on brain oxidative stress as measured by magnetic resonance spectroscopy, blood pressure, blood biomarkers, mood, cognition and sleep. Outcomes will be collected at 6 and 12 weeks. The results of this feasibility trial will inform a future conclusive randomised controlled trial to specifically test the efficacy of melatonin on modifiable risk factors of dementia, as well as cognition and brain function. This will be the first trial to investigate the effect of melatonin in the population with MCI in this way, with the future aim of using this approach to reduce progression to dementia.Ethics and disseminationThis protocol has been approved by the Sydney Local Health District Ethics Committee (X18-0077). This randomised controlled trial will be conducted in compliance with the protocol published in the registry, the International Conference for Harmonisation on Good Clinical Practice and all other applicable regulatory requirements. The findings of the trial will be disseminated via conferences, publications and media, as applicable. Participants will be informed of results of the study at the conclusion of the trial. Eligible authors will include investigators who are involved in the conception and design of the study, the conduct of the trial, the analysis of the results, and reporting and presentation of study findings.Trial registration numberAustralian and New Zealand Clinical Trials Registry (ANZCTRN 12619000876190).Protocol versionV.8 15 October 2020.

scholarly journals Effectiveness of custom-made foot orthoses in patients with systemic lupus erythaematosus: protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042627
Author(s):  
María Reina-Bueno ◽  
María del Carmen Vázquez-Bautista ◽  
Inmaculada C Palomo-Toucedo ◽  
Gabriel Domínguez-Maldonado ◽  
José Manuel Castillo-López ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Foot Orthoses ◽  
Systemic Lupus ◽  
Custom Made ◽  
Randomised Controlled

IntroductionSystemic lupus erythaematosus (SLE) is a chronic autoimmune disease of heterogeneous involvement. The disease may affect feet with a high prevalence of symptoms such as, for example, pain, forefoot and rearfoot deformities, and biomechanics dysfunctions. Custom-made foot orthoses (CMFO) have been previously reported to be effective in patients with other rheumatic diseases. However, as far as the authors know, there exist no studies about their effectiveness in SLE. This study aims at determining the effect of CMFO versus placebo flat cushioning insoles on pain, foot functionality, fatigue and quality of life in patients with SLE.Methods and analysisA randomised controlled trial would compare the effects of (1) CMFO and group B, which received a placebo, flat cushioning insoles, for 3 months. The main outcome measures are foot pain, foot functionality and foot-related disability. The secondary outcome measures are fatigue and quality of life.Ethics and disseminationThe study has been approved by the Portal de Ética de la Investigación Biomédica de Andalucía ethical committee 1494-N-19. The results will be disseminated regardless of the magnitude or direction of effect.Trial registartion numberClinicaltrials.gov identifier NCT04098055.

scholarly journals Postcard intervention for repeat self-harm: randomised controlled trial

2010 ◽  
Vol 197 (1) ◽  
pp. 55-60 ◽  
Author(s):  
Annette L. Beautrais ◽  
Sheree J. Gibb ◽  
Alan Faulkner ◽  
David M. Fergusson ◽  
Roger T. Mulder
Keyword(s):  
Emergency Department ◽  
New Zealand ◽  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Suicidal Behaviour ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Emergency Department Presentation ◽  
Self Harm ◽  
Randomised Controlled

BackgroundSelf-harm and suicidal behaviour are common reasons for emergency department presentation. Those who present with self-harm have an elevated risk of further suicidal behaviour and death.AimsTo examine whether a postcard intervention reduces self-harm re-presentations in individuals presenting to the emergency department.MethodRandomised controlled trial conducted in Christchurch, New Zealand. The intervention consisted of six postcards mailed during the 12 months following an index emergency department attendance for self-harm. Outcome measures were the proportion of participants re-presenting with self-harm and the number of re-presentations for self-harm in the 12 months following the initial presentation.ResultsAfter adjustment for prior self-harm, there were no significant differences between the control and intervention groups in the proportion of participants re-presenting with self-harm or in the total number of re-presentations for self-harm.ConclusionsThe postcard intervention did not reduce further self-harm. Together with previous results this finding suggests that the postcard intervention may be effective only for selected subgroups.

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