Clinical Trial

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

Study acronym: HEADDSET+
Active, Not Recruiting
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-17; most recent amendment 2026-06-23.
Status change: Recruiting → Active, Not Recruiting 2026-06-23
Status change: Not Yet Recruiting → Recruiting 2025-04-21
Trial Details
NCT Number NCT06378463
Lead Sponsor University of Groningen
Collaborators: Stichting Cosis, Lentis Psychiatric Institute, GGZ Friesland
Conditions Severe Mental Illness
Enrollment 126 participants
Start Date 2024-05-06
Primary Completion 2027-05 (estimated)
Study Completion 2027-05 (estimated)
Updated on ClinicalTrials.gov 2026-06-26