NCT03962426

Efficacy of Social Cognitive Training (SCT) in Recent-onset Psychosis

Elucidating the Efficacy and Response to Social Cognitive Training (SCT) in Recent Onset Psychosis (ROP)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

Participants with recent onset psychosis (ROP) experience delusions, hallucinations, and impairment in social, cognitive and emotional functioning. Although symptoms often improve following pharmacological intervention, the marked cognitive deficits, that often precede the onset of symptoms, continue to persist despite current treatment methods. Computerized neurocognitive interventions (NCI) are a promising therapeutic approach in participants with chronic schizophrenia and individuals at risk for psychosis. Specifically, focus has shifted to social cognitive training (SCT) as treating social cognition have been shown to provide improvements not only in general cognitive deficits but is also related to improvements in functional outcome (occupational and social). NCIs include non-invasive computerized tasks that are done on a tablet. This intervention can be conducted in a clinical setting, as well as out of the comfort of one's home. Additionally, research has shown that NCIs have the potential to elicit neuroplastic effects on the brain. The purpose of this study is to explore the efficacy of a 10-hour SCT in improving the primary outcome measure, global cognition, and secondary outcome measure, global functioning, in ROP participants. It is hypothesized that participants receiving the intervention will show gains in global cognition, as well as the subdomains of social cognition, processing speed, and working memory. Additionally, participants undergoing active intervention are expected to show gains in functional connectivity primarily between the prefrontal cortex and amygdala and other brain areas, that are engaged in social cognition. Furthermore, machine learning approach will be used(support vector classification) to investigate how the decision scores of the resting state classifier, indicating health vs. disease proneness, change in response to the training. In this randomized controlled trial, participants with a ROP receive a 4-6-week treatment with 10 hours of SCT, with 30-minute sessions 4-5 times per week or treatment as usual (TAU) control condition. Baseline and follow-up (6 weeks after the baseline assessment) assessments include clinical diagnostic and symptom assessment, standard neuropsychological testing, and structural and functional imaging. The already recruited part of the ROP sample counts 27 participants in SCT and 27 in the TAU arm. The power analysis recommends to recruit at least 6 more participants in both study arms. For the purpose of machine learning part of the analysis an independent psychosis (ROP)-healthy population (HC) classifier will be used, which takes the data from the naturalistic multi-center european study, Personalized Prognostic Tools for Early Psychosis Management, in order to be able to track the decision scores of the intervention SCT sample without risk of overfitting.

Conditions

• Psychosis

Interventions

Type	Name	Description
DEVICE	SocialVille Social Cognitive Training	SocialVille exercises in this study include 4 exercises: * Recognition: a speeded face matching task * Face to Face: a speeded facial emotion matching task * Gaze Match: a speeded gaze matching task * Face Poke: a continuous performance task with facial expressions

Timeline

• Start date: 2016-05-01
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2019-05-24
• Last updated: 2020-01-10

Locations

1 site across 1 country: Germany