Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06378463

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Waiting Period

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

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

Follow-up

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

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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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