Improving outcome through improving cognition in Severe Mental Illness: Cognitive Remediation Training combined with transcranial Direct Current Stimulation, a pilot study.

Conditions: Severe Mental Illness

Registration Number: NL-OMON20040

Lead Sponsor: This study is funded by Stichting tot Steun VCVGZ.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

Service users can be included if they meet the criteria for SMI (Delespaul et al., 2013):
- 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.
Each participant in the study should sign informed consent, and only those who are fully capable of making their own decision regarding participation in the study will be included. Additional criteria for inclusion are an age of 18 years or older and sufficient mastery of Dutch language.

Exclusion Criteria

Service users will be excluded from tDCS if they have:
- Metal implants inside the skull or eye;
- Severe scalp skin lesions;
- A history of previous seizures.
- Alcohol or drug abuse;
- Pregnancy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main objective of this pilot study is to investigate the effect of cognitive remediation training with CIRCuiTS on cognitive and daily functioning in a population of service users with severe mental illness that requires long-term intensive psychiatric treatment and support in a clinical setting. Also, the acceptability and feasibility of CIRCuiTS will be evaluated.

Secondary Outcome Measures

Name	Time	Method
A secondary aim of this pilot study is to evaluate if mild non-invasive brain stimulation using prefrontal transcranial Direct Current Stimulation (tDCS) in combination with CIRCuiTS has a superior effect on cognitive performance and daily functioning over CIRCuiTS + sham tDCS.