The experimental treatment (game-supported TPM training) will contribute to a more effective generalisation of compensatory strategies to untrained tasks as compared to the active control group (CogniPlus training).
ID
Source
Brief title
Condition
- Structural brain disorders
Health condition
Acquired brain injury (ABI)
Research involving
Sponsors and support
Intervention
- Other intervention
Outcome measures
Primary outcome
The primary outcome measure is an objective assessment of strategy-use in an untrained experimental task (Online Meeting Task) measures before (T0) and post-treatment (T1).
Secondary outcome
The secondary outcome is a standardised measuring scale to evaluate to what extent three individual treatment goals are achieved (Goal Attainment Scale) before (T0) and post-treatment (T1). Moreover, a neuropsychological test battery and questionnaires will be administered to assess information processing speed and other aspects of cognitive functioning at baseline (T0). Questionnaires and part of the neuropsychological tests will be repeated post-treatment (T1) to control for potential nonspecific recovery. A follow-up measurement (T2) is obtained that includes several questionnaires three months after treatment.
Background summary
Rationale: 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 support the learning process of the patient, give more insight into their progression and allow the patient to practice the strategies at home in a safe and controlled environment. Until now brain games have only focused on function training rather than learning compensatory strategies, with no or limited generalization of improvement for a patients daily life. Our hypothesis is that the game-supported Time Pressure Management (TPM) training will contribute to 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. 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 (>6months post-onset) focusing on a generalisation of strategy-use in an untrained experimental task. Our secondary objective is examining the subjective experience of participating patients as measured by GAS (Goal Attainment Scale). Study design: The study will be a 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). Study population: The study population consists of patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must experience problems with slowed IPS due to acquired brain injury (ABI) of nonprogressive nature (i.e. TBI, stroke) with a minimal time post-onset of 6 months. Age has to be between 18 and 70 and participants have to live independently at home. Slowed IPS will be assessed by the Mental Slowness Questionnaire (MSQ). Participants will be recruited from the outpatient clinic and the department of neurorehabilitation of Klimmendaal rehabilitation centre. In the course of 3 years 60 participants will be recruited. Intervention: The investigational treatment is based on the standard TPM training (see Introduction and Rationale), part of the cognitive rehabilitation intervention at Klimmendaal rehabilitation centre 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 CogniPlus training in guidance of the therapist at the rehabilitation centre. This training is aimed to improve the speed of information processing and does not teach the patient strategies for 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. Main study parameters/endpoints: 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). A secondary parameter of the study is Goal Attainment Scaling (GAS). Moreover, questionnaires and neuropsychological tests will be administered. All measurements will be administered at baseline and post-treatment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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 at his/her work pace, and if desired additional breaks will be taken. Treatment is also non-invasive and scarcely stressful: a therapist will measure such as inserting a resting break during training. The treatment-supporting game will be played at home for one hour per week. Again, the participant can work at 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).
Study objective
The experimental treatment (game-supported TPM training) will contribute to a more effective generalisation of compensatory strategies to untrained tasks as compared to the active control group (CogniPlus training).
Study design
T0 (baseline), T1 (post-treatment), T2 (3-month follow-up)
Intervention
game-supported cognitive training
Amy Abelmann
0682885469
a.abelmann@donders.ru.nl
Amy Abelmann
0682885469
a.abelmann@donders.ru.nl
Age
Inclusion criteria
Non-progressive acquired brain injury,
Minimal time post-onset of 3 months,
Outpatient rehabilitation,
Living independently at home,
Slowed information processing speed (as indicated by MSQ score higher than 13)
Exclusion criteria
Inability to speak/understand the Dutch language,
Severe psychiatric problems (history),
Neurogenerative disorders,
Substance abuse,
Severe cognitive comorbidity,
Unable to look at a computer screen and/or operating a keyboard and/or operating a computer mouse,
Aphasia,
Neglect
Design
Recruitment
IPD sharing statement
Plan description
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9437 |
CCMO | NL74818.091.20 |
OMON | NL-OMON51933 |