Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352346
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-29
Brief Title:
A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population
Sponsor:
ProPersona
Organization:
ProPersona
Study Overview
Official Title:
Evaluation of a Compensatory Brain Game Supporting Goal Management Training Intervention Targeting Executive Function in Acquired Brain Injury Patients With Depressive andor Anxiety Symptoms a Single-case Experimental Design
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:
None
Brief Summary:
The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by Executive Function EF deficits EF deficits are often seen in patients with psychiatric disorders ie depression or anxiety In order to minimize everyday disorganization effective EF interventions are required Interventions using compensatory strategies have the potential to enable patients to minimize disabilities minimize participation problems and to function more independently in daily life A well-known evidence-based intervention that uses compensatory strategies is Goal Management Training GMT a training that has been found to alleviate depressive symptoms in a depressed population GMT entails learning and applying an algorithm in which a daily task is subdivided into multiple steps to handle executive difficulties of planning and problem solving To adopt the GMT strategy and ensure maximal profitability for patients they have to learn to use the algorithm in different situations and tasks Therefore GMT is comprehensive time-consuming and thus labour-intensive Along with this brain games become increasingly attractive as an add-on intervention most notably in an effort to develop home-based personalized care Until now however the rationale behind brain games is based on what can be considered the restorative approach ie strengthening of executive problems rather than practicing compensatory strategies with little or no transfer to improvements in daily life functioning This study therefore aims to assess the potential of a newly developed Brain Game based on compensatory strategies as an add-on to GMT to develop a shortened and partly self-paced GMT intervention The primary objective of this study is to assess whether the use of a compensatory brain game supported GMT treatment could be of interest in people with EF deficits after ABI that also suffer from depression or anxiety to improve goal achievement their executive function performance during goal-related tasks and their executive performance during an ecological valid shopping task Also we assess whether psychological symptoms alleviate following the GMT intervention and at 6-weeks follow-up The study will be a multiple-baseline across individuals single-case experimental design SCED The study population consists of brain-injured patients between 18 and 75 years old that receive in-patient mental neuropsychiatric healthcare Participants eligible for the study must have EF deficits due to nonprogressive Acquired Brain Injury ABI minumum time post-onset of 3 months and depressive or anxiety symptoms EF deficits will be assessed by extensive neuropsychological examination Participants will be recruited from an inpatient clinic In the course of one and a half year four participants will be recruited
Detailed Description:
Not provided
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