The primary objective is to examine the efficacy of a strategy-game supported TPM intervention for the treatment of slowed IPS of patients with acquired brain injury (ABI) in the chronic phase (>3months post-onset) focusing on a generalization of…
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Brief title
Condition
- Other condition
Synonym
Health condition
niet-aangeboren hersenletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is strategy-use measured by an experimental task that
investigates the application of cognitive strategies in an online meeting (int.
al. the percentage change of the number of correct strategies). Participants
perform the task before and after treatment (two counterbalanced parallel
versions).
Secondary outcome
Our secondary objectives are to investigate the subjective experience of
treatment outcomes and strategy-use in daily life. This will be measured by GAS
(Goal Attainment Scaling) and by a questionnaire with questions about
strategy-use in daily life (Vragenlijst Omgaan met Tijdsdruk). Moreover,
questionnaires and neuropsychological tests will be administered.
Background summary
Brain-injured patients referred for outpatient rehabilitation experience
difficulties with processing and retaining information due to slowed
information processing speed (IPS), or mental slowness. Patients may experience
externally observed slowness, such as slow performance on neuropsychological
tasks, as well as problems with information processing in daily life in which
events proceed at a rate they cannot control. Time Pressure Management (TPM)
training is a successful treatment for these problems. The treatment allows
patients to determine during which moments of a situation they experience time
pressure and learn strategies to compensate for their slowed speed of
information processing. However, there is only a limited amount of time during
each session to learn and train these strategies with the cognitive trainer.
Our research tries to fill this gap by introducing treatment-supporting
strategy games that are personalised to the needs and level of the patient,
give more insight in their progression and allow the patient to practice the
strategies at home in a safe and controlled environment. Until now, however,
brain games have only focused on function training rather than learning
compensatory strategies, with no or limited generalisation of improvement for a
patients daily life. We hypothesise that the game-supported Time Pressure
Management (TPM) training will contribute to a more effective generalisation of
compensatory strategies to untrained tasks and thereby contributing to the
improvement of strategy-use for slowed information processing speed (IPS) in
daily life.
Study objective
The primary objective is to examine the efficacy of a strategy-game supported
TPM intervention for the treatment of slowed IPS of patients with acquired
brain injury (ABI) in the chronic phase (>3months post-onset) focusing on a
generalization of strategy-use in an untrained experimental task. Our secondary
objectives are to investigate the subjective experience of treatment outcomes
and strategy-use in daily life.
Study design
The study will be a double blind randomised controlled trial in which the
efficacy of the game-supported TPM training (8 weeks) will be compared with an
active control group (8 week CogniPlus training).
Intervention
The investigational treatment is based on the standard TPM training, part of
the cognitive rehabilitation intervention at Klimmendaal rehabilitation center
that is used for ABI patients with slowed IPS. The investigational treatment
will combine the TPM training with a cognitive strategy game targeting slowed
IPS. Both the training as well as the game aim to teach cognitive strategies
for situations in which the patient experiences time pressure and thereby give
possibilities for the patient to alleviate problems related to slowed IPS. The
training is given by the therapist and the game will be played at home. The
active control group will follow the SPEED module of the CogniPlus training in
the guidance of the therapist at the rehabilitation center. This module is
aimed to improve the speed of information processing and does not teach the
patient strategies on dealing with slowed information processing in daily life.
Both types of intervention consist of 8 sessions (max 60 minutes) and will be
given once a week.
Study burden and risks
All tests and methods that are used are non-invasive and not stressful for the
patient. All tests and tasks will be widely-used validated and reliable
paper-pencil or computerized tasks. The participant can work in his/her work
pace, and if desired additional breaks will be taken. Treatment is also
non-invasive and scarcely stressful: a therapist will always be present and
assess the patient*s burden and eventually take appropriate measures such as
inserting a resting break. The treatment-supporting game will be played at home
for one hour per week. Again, the participant can work in his/her own pace,
take breaks during and between the levels and can stop playing the game at any
moment (e.g. if the participant gets tired).
Heijenoordseweg 5
Arnhem 6813 GG
NL
Heijenoordseweg 5
Arnhem 6813 GG
NL
Listed location countries
Age
Inclusion criteria
Age: 18-70
Non-progressive acquired brain injury
Minimal time post-onset of 3 months
Outpatient rehabilitation
Living independently at home
Slowed information processing speed (assessment by MSQ, score >= 13)
Exclusion criteria
Inability to speak/understand the Dutch language
Severe psychiatric problems (history)
Neurogenerative disorders
Substance abuse
Severe cognitive comorbidity (eg dementia)
Unable to look at a computer screen for more than 15 minutes
Unable to operate a keyboard and/or a computer mouse
No access to a smartphone, and laptop or tablet
Aphasia
Neglect
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL74818.091.20 |
OMON | NL-OMON22586 |