Strategy Game Supporting Goal Management Training Intervention

Acquired Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621941
• Other study ID #: Karman Line GMT
• Secondary ID: Dutch Trial Regi
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: June 2023
• Source: Klimmendaal Revalidatiespecialisten
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 20, 2023
• Est. primary completion date: May 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Executive Dysfunction

Intervention

Behavioral:
• Game-Supported Goal Management Training
The investigational treatment is based on a compensatory strategy training named Goal Management Training (GMT). The investigational treatment will include GMT in combination with a compensatory strategy game which allows the patient to learn and apply the algorithm of GMT in a safe and controlled environment. This means that the multiple steps of the GMT will be learned during the treatment sessions under guidance of a therapist as well as in their own home environment by using the compensatory strategy game.
• Information Group
In the information group, patients are informed about non-specific consequences of acquired brain injury, aimed to increase patient's insight into their condition and with that improving functioning. The program consists of the following subjects: 1) cause of brain injury, 2) information processing and attention, 3) memory, 4) planning and performance, 5) fatigue, 6) changes in emotion and behavior and 7) processing and adjustments.

Locations

Country	Name	City	State
Netherlands	Klimmendaal Revalidatiespecialisten	Arnhem	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Klimmendaal Revalidatiespecialisten

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline performance on untrained IADL tasks immediately after the intervention	Standardized scale measuring performance of an untrained IADL task (int. al. the percent change in the number of correct steps) before (baseline) and after treatment (post treatment). The untrained IADL tasks will be divided into multiple steps using the GMT method. These steps will be assessed using four categories: 1) additional/unrelated; 2) absent/incomplete; 3) questionable/ineffective; 4) competent/correct, using task-specific assessment forms.	Baseline and immediately after the intervention
Secondary	Change from baseline Goal Attainment Scaling (GAS) on untrained task performance immediately after the intervention	Quantifying the subjective improvement on untrained task performance	Baseline and immediately after the intervention
Secondary	Change from baseline subjective strategy use immediately after the intervention	The subjective experience of strategy use in daily life and during the performance of IADL tasks, as measured by two short self-reported questionnaires.	Baseline and immediately after the intervention
Secondary	Change from baseline participation as measured by the USER-P immediately after the intervention	"Utrecht Scale for Evaluation of Rehabilitation - Participation" (USER-P)	Baseline and immediately after the intervention
Secondary	Change from baseline executive functioning as measured with the Zoo map test immediately after the intervention	Zoo map test	Baseline and immediately after the intervention
Secondary	Change from baseline executive functioning as measured with the modified six elements test immediately after the intervention	Modified six elements test	Baseline and immediately after the intervention
Secondary	Change from baseline executive functioning as measured with the Brixton immediately after the intervention	Brixton	Baseline and immediately after the intervention
Secondary	Change from baseline subjective cognitive complaints as measured with the Cognitive Failure Questionnaire (CFQ) immediately after the intervention	Cognitive Failure Questionnaire (CFQ)	Baseline and immediately after the intervention
Secondary	Change from baseline executive functioning as measured with the OxMET-NL immediately after the intervention	Oxford Multiple Errands Test - Dutch version (OxMET-NL)	Baseline and immediately after the intervention
Secondary	Change from baseline subjective executive complaints immediately after the intervention	Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A)	Baseline and immediately after the intervention
Secondary	Change from baseline Goal Attainment Scaling (GAS) on treatment goals immediately after the intervention	Quantifying the achievement of treatment goals, only measured in the game-supported GMT group.	Baseline and immediately after the intervention
Secondary	System Usability Scale (SUS) questionnaire	To evaluate the usability of the game-supported GMT treatment.	Immediately after the intervention
Secondary	Technological Acceptance Model (TAM) questionnaire	To evaluate the user-acceptance of the game-supported GMT treatment.	Immediately after the intervention

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