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Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

ABSTRACT: BACKGROUND:Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits. Despite the functional significance of the social cognition deficits affecting many aspects of daily living, such as social relationships, occupational status, and independent living, there is still no effective treatment option for these deficits, which is applied as standard of care. To address this need, we developed a novel, internet-based training program that targets social cognition deficits in schizophrenia (SocialVille). Preliminary studies demonstrate the feasibility and initial efficacy of Socialville in schizophrenia patients (Nahum et al., 2014). The purpose of the current trial (referred to as the TReatment of Social cognition in Schizophrenia Trial or TRuSST) is to compare SocialVille to an active control training condition, include a larger sample of patients, and assess both social cognitive functioning, and functional outcomes. METHODS/DESIGN:We will employ a multi-site, longitudinal, blinded, randomized controlled trial (RCT) design with a target sample of 128 patients with schizophrenia. Patients will perform, at their home or in clinic, 40 sessions of either the SocialVille training program or an active control computer game condition. Each session will last for 40-45 minutes/day, performed 3-5 days a week, over 10-12 weeks, totaling to 30 hours of training. Patients will be assessed on a battery of social cognitive, social functioning and functional outcomes immediately before training, mid-way through training (after 20 training sessions) and at the completion of the 40 training sessions. DISCUSSION:The strengths of this protocol are that it tests an innovative, internet-based treatment that targets fundamental social cognitive deficits in schizophrenia, employs a highly sensitive and extensive battery of functional outcome measures, and incorporates a large sample size in an RCT design. TRIAL REGISTRATION:ClinicalTrials.gov NCT02246426 Registered 16 September 2014.

SUBMITTER: Rose A

PROVIDER: S-EPMC4489025 | biostudies-literature | 2015 Jul

REPOSITORIES: biostudies-literature

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Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

Rose Annika A Vinogradov Sophia S Fisher Melissa M Green Michael F MF Ventura Joseph J Hooker Christine C Merzenich Michael M Nahum Mor M

BMC psychiatry 20150703

<h4>Background</h4>Schizophrenia is a severe and chronic medical condition, characterized by positive and negative symptoms, as well as pervasive social cognitive deficits. Despite the functional significance of the social cognition deficits affecting many aspects of daily living, such as social relationships, occupational status, and independent living, there is still no effective treatment option for these deficits, which is applied as standard of care. To address this need, we developed a nov ...[more]

PMID: 26138715

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Project description:BACKGROUND:Schizophrenia leads to profound disability in everyday functioning (e.g., difficulty finding and maintaining employment, housing, and personal relationships). Medications can effectively reduce positive symptoms (e.g., hallucinations and delusions), but they do not meaningfully improve daily life functioning. Psychosocial evidence-based practices (EBPs) improve functioning, but these EBPs are not available to most people with schizophrenia. The field must close the research and service delivery gap by adapting EBPs for schizophrenia to facilitate widespread implementation in community settings. Our hybrid effectiveness and implementation study represents an initiative to bridge this divide. In this study we will test whether an existing EBP (i.e., Cognitive Behavioral Social Skills Training (CBSST)) modified to work in practice settings (i.e., Assertive Community Treatment (ACT) teams) commonly available to persons with schizophrenia results in better consumer outcomes. We will also identify key factors relevant to developing future CBSST implementation strategies. METHODS/DESIGN:For the effectiveness study component, persons with schizophrenia will be recruited from existing publicly funded ACT teams operating in community settings. Participants will be randomized to one of the 2 treatments (ACT alone or ACT + Adapted CBSST) and followed longitudinally for 18 months with assessments every 18 weeks after baseline (5 in total). The primary outcome domain is psychosocial functioning (e.g., everyday living skills and activities related to employment, education, and housing) as measured by self-report, testing, and observation. Additional outcome domains of interest include mediators of change in functioning, symptoms, and quality of services. Primary analyses will be conducted using linear mixed-effects models for continuous data. The implementation study component consists of a structured, mixed qualitative-quantitative methodology (i.e., Concept Mapping) to characterize and assess the implementation experience from multiple stakeholder perspectives in order to inform future implementation initiatives. DISCUSSION:Adapting CBSST to fit into the ACT service delivery context found throughout the United States creates an opportunity to substantially increase the number of persons with schizophrenia who could have access to and benefit from EBPs. As part of the implementation learning process training materials and treatment workbooks have been revised to promote easier use of CBSST in the context of brief community-based ACT visits. TRIAL REGISTRATION:ClinicalTrials.gov NCT02254733 . Date of registration: 25 April 2014.

Project description:BackgroundThe number of people with cognitive deficits and diseases, such as stroke, dementia, or attention-deficit/hyperactivity disorder, is rising due to an aging, or in the case of attention-deficit/hyperactivity disorder, a growing population. Neurofeedback training using brain-computer interfaces is emerging as a means of easy-to-use and noninvasive cognitive training and rehabilitation. A novel application of neurofeedback training using a P300-based brain-computer interface has previously shown potential to improve attention in healthy adults.ObjectiveThis study aims to accelerate attention training using iterative learning control to optimize the task difficulty in an adaptive P300 speller task. Furthermore, we hope to replicate the results of a previous study using a P300 speller for attention training, as a benchmark comparison. In addition, the effectiveness of personalizing the task difficulty during training will be compared to a nonpersonalized task difficulty adaptation.MethodsIn this single-blind, parallel, 3-arm randomized controlled trial, 45 healthy adults will be recruited and randomly assigned to the experimental group or 1 of 2 control groups. This study involves a single training session, where participants receive neurofeedback training through a P300 speller task. During this training, the task's difficulty is progressively increased, which makes it more difficult for the participants to maintain their performance. This encourages the participants to improve their focus. Task difficulty is either adapted based on the participants' performance (in the experimental group and control group 1) or chosen randomly (in control group 2). Changes in brain patterns before and after training will be analyzed to study the effectiveness of the different approaches. Participants will complete a random dot motion task before and after the training so that any transfer effects of the training to other cognitive tasks can be evaluated. Questionnaires will be used to estimate the participants' fatigue and compare the perceived workload of the training between groups.ResultsThis study has been approved by the Maynooth University Ethics Committee (BSRESC-2022-2474456) and is registered on ClinicalTrials.gov (NCT05576649). Participant recruitment and data collection began in October 2022, and we expect to publish the results in 2023.ConclusionsThis study aims to accelerate attention training using iterative learning control in an adaptive P300 speller task, making it a more attractive training option for individuals with cognitive deficits due to its ease of use and speed. The successful replication of the results from the previous study, which used a P300 speller for attention training, would provide further evidence to support the effectiveness of this training tool.Trial registrationClinicalTrials.gov NCT05576649; https://clinicaltrials.gov/ct2/show/NCT05576649.International registered report identifier (irrid)DERR1-10.2196/46135.

Project description:BackgroundProblems in social functioning (e.g., unemployment, social isolation), are common in people with a psychotic disorder. Social cognition is a treatment target to improve social functioning, as it is a proximal predictor of social functioning. Social Cognition Training (SCT) improves social cognition, but may not generalize (enduringly) to social functioning, perhaps due to insufficient opportunity to practice in daily-life social situations. Using virtual reality (VR) for SCT could address this problem, as VR is customizable, accessible, and interactive. We will test the effect of a VR SCT, 'DiSCoVR', on social cognition and social functioning in a randomized controlled trial (RCT).MethodsIn total 100 people with a psychotic disorder and deficits in social cognition will be recruited for this multicenter randomized controlled trial (RCT). Participants will be randomized to VR SCT (DiSCoVR) or VR relaxation training (VRelax; active control). DiSCoVR is a 16-session individual SCT, consisting of three modules: 1) emotion perception (recognizing facial emotions in a virtual shopping street); 2) social perception and theory of mind (observing social interactions between virtual characters and assessing their behavior, emotions and thoughts); and 3) application of higher-order social cognition in social interaction (role-playing personalized situations in VR). People receiving VRelax complete sixteen individual sessions, in which they receive psycho-education about stress, identify personal stressors, learn relaxation techniques, and explore relaxing immersive virtual environments. Assessments will be performed at baseline, post-treatment, and 3-month follow-up. Primary outcomes are emotion perception (Ekman 60 Faces), social perception and theory of mind (The Awareness of Social Inference Test). Secondary outcomes include social functioning (Personal and Social Performance Scale), experiences and social interactions in daily life (experience sampling of emotions, social participation and subjective experience of social situations), psychiatric symptoms (e.g., depression, perceived stress, anxiety, positive and negative symptoms) and self-esteem.DiscussionTo our knowledge, this will be the first RCT testing the efficacy of VR SCT. It will also investigate generalization to daily life social situations, the durability of treatment effects, and moderators and mediators of treatment success.Trial registrationOn December 5, 2017, this trial was registered prospectively in the Dutch Trial Register as NTR6863 .

Project description:Individuals with schizophrenia have functionally significant deficits in automatic and controlled social cognition, but no currently available pharmacologic treatments reduce these deficits. The neuropeptide oxytocin has multiple prosocial effects when administered intranasally in humans and there is growing interest in its therapeutic potential in schizophrenia.We administered 40 IU of oxytocin and saline placebo intranasally to 29 male subjects with schizophrenia and 31 age-matched, healthy controls in a randomized, double-blind, placebo-controlled, cross-over study. Social cognition was assessed with The Awareness of Social Inference Test (TASIT) and the Reading the Mind in the Eyes Test (RMET). We examined the effects of oxytocin administration on automatic social cognition (the ability to rapidly interpret and understand emotional cues from the voice, face, and body); controlled social cognition (the ability to comprehend indirectly expressed emotions, thoughts, and intentions through complex deliberations over longer time periods); and a control task (the ability to comprehend truthful dialog and perform general task procedures) in individuals with and without schizophrenia using mixed factorial analysis of variance models.Patients with schizophrenia showed significant impairments in automatic and controlled social cognition compared to healthy controls, and administration of oxytocin significantly improved their controlled, but not automatic, social cognition, F(1, 58)=8.75; p=0.004. Conversely, oxytocin administration had limited effects on social cognition in healthy participants. Patients and controls performed equally well and there were no effects of oxytocin administration on the control task.Intact social cognitive abilities are associated with better functional outcomes in individuals with schizophrenia. Our data highlight the potentially complex effects of oxytocin on some but not all aspects of social cognition, and support the exploration of intranasal oxytocin as a potential adjunct treatment to improve controlled social cognition in schizophrenia.

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Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

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Randomized controlled trial of computer-based treatment of social cognition in schizophrenia: the TRuSST trial protocol.

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