Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378463
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-04-17
Brief Title:
Cognitive Remediation and Transcranial Direct Current Stimulation in Severe Mental Illness SMI
Sponsor:
University of Groningen
Organization:
University of Groningen
Study Overview
Official Title:
Improving Outcome Through Improving Cognition in Severe Mental Illness Cognitive Remediation Training Combined With Transcranial Direct Current Stimulation a Randomized Sham-controlled Multi-center Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEADDSET
Brief Summary:
Seven per cent of patients suffering from severe mental illness SMI need long-term intensive treatment and support in a clinical setting or sheltered living These service users often experience problems on multiple domains such as persistent complaints as a result of medication resistance physical health problems and self-care psychosocial and cognitive dysfunctioning Cognitive remediation CR training is a type of training aimed at improving thinking abilities cognitive functioning and daily functioning However we dont yet know if CR training can also help people with SMI who need supported housing due to their severe cognitive and daily living problems In this project we are investigating whether we can improve daily functioning in this group by using a form of CR training that focuses on learning new cognitive skills and how to use these new skills in everyday life Additionally we are exploring whether combining CR training with mild brain stimulation transcranial Direct Current Stimulation can enhance the effects of CR training
Detailed Description:
A fundamental challenge for many people with severe mental illness SMI is dealing with the impact of cognitive impairments in daily life functioning A possible treatment approach is cognitive remediation training CR a training developed to target cognitive deficits with the ultimate aim to improve daily functioning Participants engage in cognitive exercises learn more about their own cognition and the use of cognitive strategies to compensate for deficits However in people with SMI abnormal synaptic plasticity is observed This might hinder newly learned cognitive skills to sustain and limit the benefits from CR For this reason people with SMI may benefit from the combination of CR with a method that may promote neural plasticity transcranial direct current stimulation tDCS
In a pragmatic triple-blinded randomized sham-controlled multi-center trial with a multiple baseline design we will investigate the effectiveness of combining CR and tDCS in helping participants reach personal goals minimizing problems in daily functioning and improving cognitive functioning 126 service users with SMI will receive 16-20 weeks of twice-weekly CR combined with active N63 or sham tDCS N63 We will perform functional cognitive and clinical outcome assessments at baseline after a 16-week waiting period post-treatment and 6-months post-treatment and compare the effects within-participants waiting period vs treatment period and between-participants CRactive tDCS vs CRsham tDCS This multi-center trial will evaluate whether CR on its own and whether CR in combination with tDCS can be a clinically relevant addition to further enhance recovery through enhancing service users goal attainment daily functioning and cognitive performance In case results of this trial confirm our hypotheses it may be recommended to include the combined information in the guidelines for SMI care and to implement the method in standardized care
In a pragmatic triple-blinded randomized sham-controlled multi-center trial with a multiple baseline design we will investigate the effectiveness of combining CR and tDCS in helping participants reach personal goals minimizing problems in daily functioning and improving cognitive functioning 126 service users with SMI will receive 16-20 weeks of twice-weekly CR combined with active N63 or sham tDCS N63 We will perform functional cognitive and clinical outcome assessments at baseline after a 16-week waiting period post-treatment and 6-months post-treatment and compare the effects within-participants waiting period vs treatment period and between-participants CRactive tDCS vs CRsham tDCS This multi-center trial will evaluate whether CR on its own and whether CR in combination with tDCS can be a clinically relevant addition to further enhance recovery through enhancing service users goal attainment daily functioning and cognitive performance In case results of this trial confirm our hypotheses it may be recommended to include the combined information in the guidelines for SMI care and to implement the method in standardized care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None