Evaluation of a Compensatory Brain Game Supporting Goal Management Training Targeting Executive Function After Acquired Brain Injury Using Single-case Experimental Design Methodology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The target behavior (i.e. performance on an untrained shopping task) will be measured repeatedly, on a minimum of six occasions in each phase where possible, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). Repeated measures of target behavior will be assessed via the OxMET-NL task and is scored automatically: no assessor input is required to either save or score the main outcome data. The secondary outcome measure(s) are scored by an outcome assessor who is blind to the order in which the secondary outcome measure(s) were taken.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •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
Arms & Interventions
Baseline phase (Phase A)
At the start of the study, all participants are assigned to the baseline phase (phase A). During phase A, patients do not receive interventions related to executive function problems. The start of the intervention phase (phase B) is determined randomly for each participant, given the restriction that phase A should last for at least three weeks (21 days) and at most five weeks (30 days). This means that phase B can start on any day between the 21th and the 30th days, resulting in a total of 10 possible assignments. So, in the first three weeks, all participants are in phase A. The duration of phase A will thus be different for each subject. Phase A acts as a control and is therefore compared with phase B.
Intervention phase (Phase B): Goal Management Training
During the intervention phase (phase B), all included participants will have 6 sessions of Goal Management Training (GMT; twice per week) in which two individual chosen IADL-tasks will be subdivided into multiple steps under guidance of a therapist using the GMT method. In addition participants play the compensatory brain game in which they are challenged to apply the learned GMT strategy in an imaginary and safe environment.
Intervention: Intervention during phase B: Compensatory brain game supporting Goal Management Training intervention (Behavioral)
Follow-up period
A follow-up period of three weeks takes place after phase B. During this follow-up period, patients receive no intervention.
Outcomes
Primary Outcomes
Change in performance on the Oxford Multiple Errands Test- Dutch version (OxMET-NL) from phase A to phase B
Time Frame: 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)
The target behavior will be assessed repeatedly, on a minimum of six occasions in phase A and B, in accordance with the recommendations of the What Works Clearinghouse and RoBiNT criteria (Tate et al., 2013). The OxMET-NL task is a computer-tablet based version of the Multiple Errands Test and is scored automatically. The task requires patients to buy six items and to answer two questions.
Secondary Outcomes
- Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)(pre-intervention, immediately following intervention and at three weeks follow-up)
- Change in strategy use during the performance of trained and untrained IADL tasks(pre-intervention, immediately following intervention and at three weeks follow-up)
- Change on the Visual Analogue Scale (VAS) from phase A to phase B to follow-up(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))
- Change in subjective experience of strategy use in daily life(pre-intervention, immediately following intervention and at three weeks follow-up)
- Change in performance on two trained IADL task (treatment goals)(pre-intervention, immediately following intervention and at three weeks follow-up)
- Change in everyday difficulties in activities/participation as measured on the Daily Living Questionnaire (DLQ-R-NL)(pre-intervention, immediately following intervention and at three weeks follow-up)