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

Completed

Conditions: Severe Mental Illness
Psychiatric Disorders
10037176

Registration Number: NL-OMON50031

Lead Sponsor: entis (Groningen)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

Inclusion Criteria

Service users can be included if they meet the criteria for Severe MEntal
Illness (Delespaul et al., 2013):
- A psychiatric disorder that requires care/treatment (no symptomatic
remission);
- 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 or
older and sufficient mastery of Dutch language.

Exclusion Criteria

- Metal implants inside the skull or eye;
- Severe scalp skin lesions;
- A history of previous seizures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main objective of this pilot study is to investigate the effect of<br /><br>cognitive remediation training with CIRCuiTS on cognitive and daily functioning<br /><br>in a population of service users with severe mental illness that requires<br /><br>long-term intensive psychiatric treatment and support in a clinical setting.<br /><br>Also, the acceptability and feasibility of CIRCuiTS will be evaluated. CIRCuiTS<br /><br>is especially developed and tested for service users with schizophrenia. It is,<br /><br>until date, not investigated in service users with SMI that need long-term<br /><br>intensive psychiatric treatment in a clinical or sheltered setting. In the case<br /><br>of positive results, we aim to initiate a large multicenter randomized<br /><br>controlled trial, using CIRCuiTS. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>A secondary aim of this pilot study is to evaluate if mild non-invasive brain<br /><br>stimulation using transcranial Direct Current Stimulation (tDCS) in combination<br /><br>with CIRCuiTS has a superior effect on cognitive performance and daily<br /><br>functioning over CIRCuiTS alone. As neural plasticity may be reduced in service<br /><br>users with SMI, effects of cognitive training may not sustain. Applying tDCS to<br /><br>neural networks simultaneously with their engagement in cognitive tasks of<br /><br>CIRCuiTS, it is expected that plasticity of these networks will be increased,<br /><br>resulting in long lasting improvements in cognitive and daily functioning.<br /><br>Also, the acceptability and feasibility of this combined intervention will be<br /><br>evaluated. When tDCS appears to have an additive effect, it will be applied in<br /><br>combination with CIRCuiTS in a large multicenter randomized controlled trial. </p><br>