NCT06378463 Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)
| NCT ID | NCT06378463 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Groningen |
| Condition | Severe Mental Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-05-06 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2024-05-06 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * A psychiatric disorder that requires care/treatment (no remission of positive, negative and cognitive symptoms); * Severe disabilities in social and/or societal functioning (no functional remission); * Disabilities are the result of a psychiatric disorder; * Disabilities are structural (at least several years); * Coordinated professional care is necessary to realize a treatment plan; * Adults between the age of 18 and 65; * Sufficient written and oral mastery of the Dutch language. Exclusion Criteria: * Having previously received CIRCuiTS; * Metal implants inside the skull or eye; * Severe scalp skin lesions; * A history of previous seizures; * Alcohol or drug abuse.
Contact & Investigator
Lisette van der Meer, PhD
PRINCIPAL INVESTIGATOR
Department of Clinical and Developmental Neuropsychology
Frequently Asked Questions
Who can join the NCT06378463 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Severe Mental Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06378463 currently recruiting?
Yes, NCT06378463 is actively recruiting participants. Contact the research team at l.van.der.meer@rug.nl for enrollment information.
Where is the NCT06378463 trial being conducted?
This trial is being conducted at Assen, Netherlands, Zuidlaren, Netherlands, Leeuwarden, Netherlands.
Who is sponsoring the NCT06378463 clinical trial?
NCT06378463 is sponsored by University of Groningen. The principal investigator is Lisette van der Meer, PhD at Department of Clinical and Developmental Neuropsychology. The trial plans to enroll 126 participants.