Clinical trial NCT06352346: A Single-case Design to Investigate a Compensatory Brain Game Supporting Goal Management Training Intervention in a Psychiatric Brain Injury Population
Official title: Evaluation of a Compensatory Brain Game Supporting Goal Management Training Intervention Targeting Executive Function in Acquired Brain Injury Patients With Depressive and/or Anxiety Symptoms: a Single-case Experimental Design
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Depressive Symptoms
Anxiety
Executive Dysfunction
Keywords: Goal Management Training
Compensatory Strategy Training
Serious Gaming
Lead sponsor: ProPersona
Sponsor class: OTHER
First posted: 2024-04-08
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 6 weeks. 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. 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.

Detailed description: Not provided

Eligibility criteria: 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

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 (36 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 (6 weeks)
measure: Change in performance on treatment goals as measured with the Goal Attainment Scale (GAS)
timeFrame: pre-intervention, immediately following intervention and at six weeks follow-up
measure: Change in performance on two trained IADL task (treatment goals)
timeFrame: pre-intervention, immediately following intervention and at six 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 six 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 six weeks follow-up
measure: Change in subjective experience of strategy use in daily life
timeFrame: pre-intervention, immediately following intervention and at six weeks follow-up
measure: Change in subjectively experienced psychological symptoms such as depressive, anxiety and stress symptoms.
timeFrame: pre-intervention, immediately following intervention and at six weeks follow-up
Other outcomes:
Locations:
city: Wolfheze
country: Netherlands
facility: ProPersona
state: Gelderland
Study officials:
References:
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