Clinical trial NCT05737238: A Single-case Design to Investigate a Compensatory Strategy Game Supporting Goal Management Training
Official title: Evaluation of a Compensatory Brain Game Supporting Goal Management Training Targeting Executive Function After Acquired Brain Injury Using Single-case Experimental Design Methodology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acquired Brain Injury
Executive Dysfunction
Goal Management Training
Compensatory Strategy Training
Serious Gaming
Lead sponsor: Klimmendaal Revalidatiespecialisten
Sponsor class: NETWORK
First posted: 2023-02-21
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized Single-case Experimental Design (SCED) with a follow-up period of 1 month. Participants will be first assigned to a baseline phase (phase A). The start of the treatment phase (phase B) is determined randomly for each participant, given the restriction that the baseline phase (phase A) should last for at least three weeks (21 days) and at most five weeks (30 days). This means that the treatment phase can start on any day between the 21th and the 30th days. So, in the first three weeks, all participants are in the baseline condition. The duration of baseline will thus be different for each subject. Nonspecific effects, such as linear trends, retesting or non-specific recovery, can be controlled by this approach, since expected changes in level of performance due to treatment should parallel this stepwise onset of therapy procedure.

Phase A acts as a control and is therefore compared with phase B.
Primary purpose: TREATMENT

Brief summary: The main cognitive complaint in brain-injured patients is often the everyday disorganization caused by executive function (EF) deficits. In order to minimize the everyday disorganization, effective EF interventions are required. Interventions which incorporate 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 incorporates compensatory strategies is Goal Management Training (GMT). 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 a comprehensive, time-consuming and thus labour-intensive treatment. 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 (i.e. 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 home-based 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, to improve goal achievement, their executive function performance during goal-related tasks, and their executive performance during an ecological valid shopping task. The study will be a multiple-baseline across individuals single-case experimental design (SCED). The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have executive deficits due to Acquired Brain Injury (ABI) of nonprogressive nature (i.e. TBI, stroke), with a minimum time post-onset of 3 months. Age has to be between 18 and 75 and participants have to live independently at home. Executive deficits will be assessed by extensive neuropsychological examination. Participants will be recruited from the outpatient clinic and the department of neurorehabilitation of Klimmendaal and Vogellanden. Four participants will be recruited.


Eligibility criteria: Inclusion Criteria:

* Age: 18 - 75 years
* Non-progressive acquired brain injury
* Minimal time post-onset of 3 months
* Outpatient rehabilitation
* Living independently at home
* Executive deficits (as determined on a neuropsychological assessment)

Exclusion Criteria:

* Inability to speak/understand the Dutch language
* Severe psychiatric problems (history)
* Neurodegenerative disorders
* Substance abuse
* Severe cognitive comorbidity (i.e. dementia)
* Aphasia
* Neglect
* No access to a smartphone, and laptop or tablet
* Unable to look at a computer screen for 15 minutes
* Unable to operate a keyboard or computer mouse

Primary outcomes:
measure: Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
timeFrame: The target behavior (i.e. performance on the OxMET-NL) will be measured repeatedly, two times a week, for the duration of phase A (3 to 5 weeks) and phase B (3 weeks)
Secondary outcomes:
measure: Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up
timeFrame: The VAS will be assessed repeatedly, two times a week, for the duration of phase A (3 to 5 weeks), phase B (3 weeks) and follow-up (3 weeks)
measure: Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
timeFrame: pre-intervention, immediately following intervention and at three weeks follow-up
measure: Change in performance on two trained IADL task (treatment goals)
timeFrame: pre-intervention, immediately following intervention and at three weeks follow-up
measure: Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)
timeFrame: pre-intervention, immediately following intervention and at three weeks follow-up
measure: Change in strategy use during the performance of trained and untrained IADL tasks
timeFrame: pre-intervention, immediately following intervention and at three weeks follow-up
measure: Change in subjective experience of strategy use in daily life
timeFrame: pre-intervention, immediately following intervention and at three weeks follow-up
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Klimmendaal Revalidatiespecialisten
state: Gelderland
Study officials:
affiliation: Donders Institute for Brain, Cognition and Behaviour
name: Elise Verhoog, MSc
role: PRINCIPAL_INVESTIGATOR
References: