Improving daily functioning in severe mental illness with cognitive training and brain stimulation

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

This study is testing if a combination of brain exercises and a special type of brain stimulation can help people with severe mental illness improve their thinking skills and daily life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 126 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Groningen (other)
• Locations: 3 sites (Assen, Drenthe and 2 other locations)
• Trial ID: NCT06378463 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of combining cognitive remediation (CR) training with transcranial direct current stimulation (tDCS) to enhance cognitive functioning and daily living skills in individuals with severe mental illness (SMI). Participants will engage in cognitive exercises aimed at improving their thinking abilities while receiving either active or sham tDCS over a treatment period of 16-20 weeks. The trial is designed as a triple-blinded, randomized, sham-controlled, multi-center study, assessing outcomes at multiple time points to determine the impact of the interventions on personal goals and daily functioning. The study aims to address the cognitive deficits that hinder recovery in this population.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with severe mental illness who experience significant cognitive and daily living challenges.

Not a fit: Patients with a history of seizures, severe scalp lesions, or those who have previously received cognitive remediation training may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve daily functioning and quality of life for patients with severe mental illness.

How similar studies have performed: While cognitive remediation has been explored in other contexts, the combination with tDCS in this specific population is a novel approach.

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.

Where this trial is running

Assen, Drenthe and 2 other locations

• Cosis — Assen, Drenthe, Netherlands (RECRUITING)
• Lentis — Zuidlaren, Drenthe, Netherlands (RECRUITING)
• GGZ Friesland — Leeuwarden, Provincie Friesland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Lisette van der Meer, PhD — Department of Clinical and Developmental Neuropsychology
• Study coordinator: Lisette van der Meer, PhD

Conditions: Severe Mental Illness, Cognitive training, Cognitive functioning, Cognitive rehabilitation, Cognitive remediation, Functional recovery, Community recovery, Non-invasive brain stimulation