A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population

ProPersona

Status: Not yet enrolling

Conditions: Depressive Symptoms; Acquired Brain Injury; Anxiety; Executive Dysfunction

Treatments: Behavioral: Compensatory brain game supporting Goal Management Training intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06352346

Plan Game_ABI&Psychiatry

Details and patient eligibility

About

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 i.e. 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 (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 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.

Full description

Not provided

Enrollment: 4 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age: 18 - 75 years
• Non-progressive acquired brain injury
• Minimal time post-onset of 3 months
• Receive inpatient neuropsychiatric care at the time of inclusion
• Executive deficits (neuropsychological assessment)
• Reasonable amount of awareness in their deficits, at least to the extent that they are motivated and capable to learn new skills with respect to their executive performance.

Exclusion criteria

• Inability to speak/understand the Dutch language
• Severe psychiatric disorders such as psychosis, manic episode, severe disruptive behavior
• Neurodegenerative disorders (i.e. dementia, Huntington, Parkinson
• Substance abuse (active)
• Severe cognitive comorbidity (i.e. Korsakov)
• Aphasia
• Neglect
• Unable to look at a computer screen for 15 minutes
• Unable to operate a keyboard or computer mouse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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4 participants in 3 patient groups

No Intervention: Baseline phase (Phase A)

No Intervention group

Description:

o 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.

Experimental: Intervention phase (Phase B): Goal Management Training

Experimental group

Description:

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.

Treatment:

Behavioral: Compensatory brain game supporting Goal Management Training intervention

Follow-up period

No Intervention group

Description:

A follow-up period of six weeks takes place after phase B. During this follow-up period, patients receive no intervention.