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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50031

Enrollment

Registered

2019-02-11

Start date

2020-10-06

Completion date

Unknown

Last updated

2024-08-19

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

Conditions

Psychiatric Disorders Severe Mental Illness

Interventions

Cognitive remediation training will be given with CIRCuiTS. This program is built of computerized tasks that are mainly aimed at improving attention, memory and planning, by training in many differe

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

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. CIRCuiTS is especially developed and tested for service users with schizophrenia. It is, until date, not investigated in service users with SMI that need long-term intensive psychiatric treatment in a clinical or sheltered setting. In the case of positive results, we aim to initiate a large multicenter randomized controlled trial, using CIRCuiTS.	—

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. CIRCuiTS is especially developed and tested for service users with schizophrenia. It is, until date, not investigated in service users with SMI that need long-term intensive psychiatric treatment in a clinical or sheltered setting. In the case of positive results, we aim to initiate a large multicenter randomized controlled trial, using CIRCuiTS.

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Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)