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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20040

Enrollment

Registered

2019-08-12

Start date

2019-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Mental Illness

Interventions

Cognitive training with CIRCuiTS, in combination with (active/placebo) tDCS

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactLeonie Bais

Lentis Mental Health Care

l.bais@lentis.nl+31630153163

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)