Clinical trial NCT05621941: Strategy Game Supporting Goal Management Training Intervention
Official title: A Strategy Game Supporting Goal Management Training Intervention for the Treatment of Executive Problems After Acquired Brain Injury: a Randomized Controlled Pilot Study for Usability and Preliminary Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acquired Brain Injury
Executive Dysfunction
Neuropsychological Rehabilitation
Lead sponsor: Klimmendaal Revalidatiespecialisten
Sponsor class: NETWORK
First posted: 2022-11-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many brain-injured patients referred for outpatient rehabilitation have difficulties with planning, problems solving, and reasoning. These difficulties can be characterized as executive deficits, which can vary from relatively mild to rather severe. Executive deficits lead to real-life everyday disorganization and difficulties in instrumental activities of daily living (IADL tasks). Goal Management Training (GMT) is a successful treatment for executive deficits and helps to structure activities in daily life. 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. Patients are taught compensatory strategies not to strengthen the executive functions, but to enable them to minimize disabilities and participation problems and to function more independently in daily life. The currently implemented GMT treatment in the Netherlands is aimed at relearning two specific tasks. However, to adopt the GMT strategy and ensure maximal profitability for patients, they have to learn to use the algorithm in different situations and tasks, which requires 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, and because of their machine learning algorithms which tailors the game to the level of the individual player. 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 no transfer to improvements in daily life functioning. The present study fills a gap in the literature by investigating a new developed treatment that incorporates GMT and a treatment supporting strategy game in a pilot sample of brain injured patients. The primary objective of this pilot study is to obtain an efficacy estimate and investigate the feasibility of GMT with a new game that incorporates strategy training in improving executive functions in a pilot sample of brain-injured patients. This study investigates usability and acceptability of our new developed GMT treatment to brain-injured patients in the chronic phase (\>3 months post-onset), and obtains an efficacy estimate, focusing on transfer of treatment effects to untrained (instrumental) activities of daily living. Chronic brain-injured patients will be allocated to the game-supported GMT treatment or to an information group using block randomization. It will be an assessor blind study in which researchers responsible for assessing or analyzing data will be blind for the received treatment.


Eligibility criteria: Inclusion Criteria:

* Any type of acquired brain injury of non-progressive nature in the past, being more than three months post injury.
* A Clinically meaningful score of executive complaints on the BRIEF-A.
* Aged between 18 and 70 years
* Referred for outpatient rehabilitation
* Living independently at home

Exclusion Criteria:

* Inability to speak/ understand the Dutch language
* Co-morbidity that might affect outcome (e.g. neurodegenerative disorders, aphasia, neglect, and major psychiatric illness)
* Substance abuse
* No access to a smartphone, laptop or tablet
* Unable to look at a computer screen for 15 minutes
* Being unable to operate a keyboard or computer mouse

Primary outcomes:
measure: Change from baseline performance on untrained IADL tasks immediately after the intervention
timeFrame: Baseline and immediately after the intervention
Secondary outcomes:
measure: Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline subjective strategy use immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline participation as measured by the USER-P immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline executive functioning as measured with the Brixton immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline subjective executive complaints immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention
timeFrame: Baseline and immediately after the intervention
measure: System Usability Scale (SUS) questionnaire
timeFrame: Immediately after the intervention
measure: Technological Acceptance Model (TAM) questionnaire
timeFrame: Immediately after the intervention
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Klimmendaal Revalidatiespecialisten
state: Gelderland
Study officials:
References: