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RECRUITING
NCT06378463
NA

Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)

Sponsor: University of Groningen

View on ClinicalTrials.gov

Summary

Seven per cent of patients suffering from severe mental illness (SMI) need long-term intensive treatment and support in a clinical setting or sheltered living. These service users often experience problems on multiple domains, such as persistent complaints as a result of medication resistance, physical health problems and self-care, psychosocial and cognitive dysfunctioning. Cognitive remediation (CR) training is a type of training aimed at improving thinking abilities (cognitive functioning) and daily functioning. However, we don't yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems. In this project, we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life. Additionally, we are exploring whether combining CR training with mild brain stimulation (transcranial Direct Current Stimulation) can enhance the effects of CR training.

Official title: Improving Outcome Through Improving Cognition in Severe Mental Illness: Cognitive Remediation Training Combined With Transcranial Direct Current Stimulation, a Randomized, Sham-controlled, Multi-center Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2024-05-06

Completion Date

2027-04

Last Updated

2025-05-20

Healthy Volunteers

No

Interventions

OTHER

Cognitive remediation + active tDCS

The cognitive remediation program "Computerised Interactive Remediation of Cognition - a Training for Schizophrenia" (CIRCuiTS) improves cognitive and metacognitive skills and strategies and is specifically aimed at the generalization of newly learnt skills to daily life. This method also offers the possibility to personalize the training program based on individual goals and cognitive functioning of the service user. Transcranial Direct Current Stimulation is used to promote neural plasticity, which applies a small electrical current over the cortex. This can alter the excitability of neurons, such that it increases or decreases spontaneous network activity. When applied to fronto-parietal neural networks simultaneously with their engagement in cognitive tasks of CIRCuiTS, it is expected that plasticity of these networks will be modulated, resulting in improvements in cognitive functioning. In this condition, participants will receive active brain stimulation.

OTHER

Cognitive remediation + sham tDCS

The cognitive remediation program "Computerised Interactive Remediation of Cognition - a Training for Schizophrenia" (CIRCuiTS) improves cognitive and metacognitive skills and strategies and is specifically aimed at the generalization of newly learnt skills to daily life. This method also offers the possibility to personalize the training program based on individual goals and cognitive functioning of the service user. Transcranial Direct Current Stimulation is used to promote neural plasticity, which applies a small electrical current over the cortex. This can alter the excitability of neurons, such that it increases or decreases spontaneous network activity. When applied to fronto-parietal neural networks simultaneously with their engagement in cognitive tasks of CIRCuiTS, it is expected that plasticity of these networks will be modulated, resulting in improvements in cognitive functioning. In this condition, participants will receive sham brain stimulation.

Locations (3)

Cosis

Assen, Drenthe, Netherlands

Lentis

Zuidlaren, Drenthe, Netherlands

GGZ Friesland

Leeuwarden, Provincie Friesland, Netherlands