Actively Recruiting
Improving Outcome Through Improving Cognition in Severe Mental Illness: Cognitive Remediation Training Combined With Transcranial Direct Current Stimulation
Led by University of Groningen · Updated on 2025-05-20
126
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Groningen
Lead Sponsor
S
Stichting Cosis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 65 with severe mental illness (SMI) who face long-term challenges in daily functioning due to cognitive impairments and other disabilities. The study aims to evaluate if cognitive remediation (CR) training, which helps improve thinking and daily skills, can benefit those who need supported housing. It also explores whether combining CR training with mild brain stimulation called transcranial Direct Current Stimulation (tDCS) can enhance these effects. Participants will receive 16 to 20 weeks of twice-weekly CR training, which focuses on learning new cognitive skills and applying them in daily life. They will be randomly assigned to receive either active tDCS, which delivers a small electrical current to promote brain plasticity, or sham tDCS without therapeutic effect. The active tDCS is applied for 20 minutes with specific electrode placement, while the sham procedure mimics the experience without ongoing stimulation. Throughout the study, participants will undergo assessments before treatment, after a 16-week waiting period, post-treatment, and six months later. These include questionnaires on daily living skills, goal achievement, social functioning, and various cognitive tests. The study also uses an app to monitor activities and may include interviews about participants' experiences. The research team will compare changes within individuals over time and between the two groups to understand the potential benefits and safety of these treatments.
CONDITIONS
Brief Title
Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness (SMI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A psychiatric disorder that requires care or treatment without remission of symptoms
- Severe disabilities in social or societal functioning without functional remission
- Disabilities caused by a psychiatric disorder and present for several years
- Need for coordinated professional care to follow a treatment plan
- Adults aged 18 to 65 years
- Sufficient written and spoken Dutch language skills
You will not qualify if you...
- Previous participation in the CIRCuiTS cognitive remediation program
- Presence of metal implants inside the skull or eye
- Severe scalp skin lesions
- History of seizures
- Alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants undergo a 16-week waiting period before starting treatment, during which baseline assessments are conducted.
Assessments at baseline and pre-treatment
Duration - 16 to 20 weeks
Participants receive cognitive remediation training combined with either active or sham transcranial direct current stimulation, twice weekly.
Twice-weekly sessions for 16 to 20 weeks
Duration - 6 months
Participants are assessed 6 months after completing treatment to evaluate long-term effects.
Post-treatment and 6-month follow-up assessments
Trial Site Locations
Total: 3 locations
1
Cosis
Assen, Drenthe, Netherlands, 9400 AE
Actively Recruiting
2
Lentis
Zuidlaren, Drenthe, Netherlands, 9470 AC
Actively Recruiting
3
GGZ Friesland
Leeuwarden, Provincie Friesland, Netherlands, 8932 PA
Actively Recruiting
Research Team
L
Lisette van der Meer, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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