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Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

ABSTRACT: BACKGROUND:Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder. METHODS:An estimated sixty patients will be enrolled in the study. Participants will be randomised to one of two conditions: CRT with treatment as usual (TAU), or TAU. CRT will consist of 42 individual sessions and 14 group sessions. The primary outcome measure for this study is change in cognitive functioning using the MATRICS Consensus Cognitive Battery (MCCB). Secondary outcomes include change in social and occupational functioning, disorganised symptoms, negative symptoms, violence, participation in psychosocial treatment and recovery. In addition to these effectiveness measures, we will examine patient satisfaction. DISCUSSION:Cognitive difficulties experienced by schizophrenia spectrum patients are associated with general functioning, ability to benefit from psychosocial interventions and quality of life. Research into the treatment of cognitive difficulties within a forensic setting is therefore an important priority. The results of the proposed study will help answer the question whether cognitive remediation improves functional outcomes in forensic mental health patients with schizophrenia or schizoaffective disorder. Forensic mental health patients are detained for the dual purpose of receiving treatment and for public protection. There can be conflict between these two roles perhaps causing forensic services to have an increased length of stay compared to general psychiatric admissions. Ultimately a focus on emphasising cognition and general functioning over symptoms may decrease tension between the core responsibilities of forensic mental health services. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT02360813. Trial registered Feb 4th 2015 and last updated May 1(st) 2015.

SUBMITTER: O'Reilly K

PROVIDER: S-EPMC4711170 | biostudies-literature | 2016 Jan

REPOSITORIES: biostudies-literature

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Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

O'Reilly Ken K Donohoe Gary G O'Sullivan Danny D Coyle Ciaran C Mullaney Ronan R O'Connell Paul P Maddock Catherine C Nulty Andrea A O'Flynn Padraic P O'Connell Carina C Kennedy Harry G HG

BMC psychiatry 20160113

<h4>Background</h4>Evidence is accumulating that cognitive remediation therapy (CRT) is an effective intervention for patients with schizophrenia or schizoaffective disorder. To date there has been no randomised controlled trial (RCT) cohort study of cognitive remediation within a forensic hospital. The goal of this study is to examine the effectiveness of a trial of cognitive remediation for forensic mental health patients with schizophrenia or schizoaffective disorder.<h4>Methods</h4>An estima ...[more]

PMID: 26759167

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Project description:Abstract Background Cognitive remediation (CR) is an evidence-based behavioral intervention for cognitive impairment in schizophrenia. Although the effectiveness of CR is well stablished, its effects are modest, especially in terms of functional outcome. There is an emerging literature suggesting that adding aerobic exercise to CR may exert synergistic effects. Despite these promising reports, the extent to which aerobic exercise in combination with CRT can improve cognitive and daily functioning in multiepisode schizophrenia and schizoaffective disorder remains unclear. Methods This is a single-blinded, randomized clinical trial (NCT02864576) with two different groups: 1) patients with multiepisode schizophrenia or schizoaffective disorder receiving 3-month Aerobic exercise plus CR treatment (three weekly sessions, 40min of Aerobic exercise and 90min of CR), and 2) patients with multiepisode schizophrenia or schizoaffective disorder receiving Healthy lifestyle promotion plus CR treatment (three weekly sessions, 40min of Healthy lifestyle promotion and 90min of CR). Primary outcome measures were the MATRICS Consensus Cognitive Battery (MCCB) and the Global Assessment of Functioning (GAF), which were assessed (among others) at baseline and immediately after treatment. For the present work, the sample included in the analysis were 34 patients for whom cognitive data were available. Treatment effects on neurocognition and functional outcome were analyzed by applying the multivariate general linear model (GLM) repeated measures. Results After treatment, both groups exhibited a significant improvement in MCCB visual learning memory (F=14.298, p= 0.001), working memory (F=6.626, p= 0.015) and speed of processing (F=16.344, p= 0.001) domains. However, no significant benefits were evidenced for problem solving (F=2.143, p= 0.153), verbal learning memory (F= 0.321, p= 0.575) and attention/vigilance (F=0.740, p= 0.397) domains. Functional outcome, as measured by the GAF, was more improved in the Aerobic exercise plus CR group than in the Healthy lifestyle promotion plus CR group (F=4.248, p= 0.047). Discussion Our preliminary findings indicate that combining aerobic exercise with cognitive remediation may promote a large impact on functional outcome in patients with multiepisode schizophrenia or schizoaffective disorder.

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)

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Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

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Study protocol: a randomised controlled trial of cognitive remediation for a national cohort of forensic mental health patients with schizophrenia or schizoaffective disorder.

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