To evaluate the efficacy of GMT in which errorless learning is integrated, this approach will be compared with conventional GMT treatment in which an errorful approach is used. This comparison will be investigated in a double blind randomized controlled trial that is registered at the Dutch Trial Register (No. NTR3567). The Medical Review Ethics Committee region Arnhem-Nijmegen approved the study (No. NL38019.091.11).
Participants and setting
The study population consists of brain-damaged patients referred for outpatient cognitive rehabilitation. Participants eligible for the study must have executive disorders due to acquired brain injury (ABI) of non-progressive nature (i.e. traumatic brain injury, stroke) in the chronic phase of the illness. Executive deficits will be assessed by an extensive neuropsychological examination.
1. Non-progressive acquired brain injury;
2. Minimal post-onset time of 3 months;
3. Being in outpatient rehabilitation;
4. Having executive deficits, as established by neuropsychological examination;
5. Living independently at home;
6. Age: 18–70 years at onset.
1. Inability to speak/understand the Dutch language;
2. Severe premorbid psychiatric problems;
3. Neurodegenerative disorders;
4. Substance abuse;
5. Severe cognitive comorbidity.
Patients will be recruited from the Rehabilitation Medical Centre Groot Klimmendaal in Arnhem, the Netherlands and the outpatient rehabilitation clinic for brain injured patients and the department of Neurorehabilitation of the Sint Maartenskliniek in Nijmegen, the Netherlands. In the course of 18 months 64 participants will be recruited.
A flowchart of the study design is presented in Figure
. An extensive neuropsychological assessment will be performed as part of the selection procedure. Participants are eligible for the study if they have executive impairments, objectified by neuropsychological examination. As executive functioning is a multifarious concept, the neuropsychological assessment is designed to cover five of its main aspects. To assess response generation
] the Category Fluency test (CFT) and the Letter Fluency test (LFT) will be administered. Planning will be measured with an altered version of the Modified Six Elements Test and the Zoo Map test (subtest of BADS)
]. The Go/No-go task from the computerized TAP 2.1
] will be used to examine response inhibition. Working memory will be assessed with Letter-Number Sequencing (LNS; subtest of the WAIS III)
] and task switching with the Brixton Spatial Anticipation test
]. Specifically, the criteria for having executive disorders and to be included in the study are either a standard score of 1.5 standard deviation (SD) below the normative mean on at least two of the seven executive tests or a standard score between 1 and 1.5 SD below the normative mean on at least four of those seven tests. Moreover, to obtain a complete cognitive profile of the participants, the Rivermead Behavioural Memory Test-Third Edition (RBMT III)
] will be administered to assess episodic memory and the alertness subtest of the TAP 2.1
] will be used as a measure for attention and concentration. The National Adult Reading Test (Dutch version) (NART) will be given to estimate premorbid IQ. All neuropsychological tests will be administered by a neuropsychologist or a trained assistant.
After fulfilling the inclusion criteria and obtaining the signed informed consents, participants will be randomly assigned to GMT with an errorless learning approach (experimental treatment) or to conventional GMT (treatment as usual) using trial and error learning.
Both treatment arms will comprise eight one-hour individual sessions, administered twice a week by trained therapists. An overview of the content of the training sessions is shown in Table
. Sessions 1–4 will take place at the participating centers. Sessions 5–8 will take place at the participants’ home or in the work environment, depending on the treatment goals. The first two sessions of GMT will be identical for both conditions. In the first session participants will be informed about GMT in general and about cognitive dysfunction, more specifically about executive dysfunction after acquired brain injury. In the second session each participant will choose two individual treatment goals. These treatment goals must be (i)ADL tasks and the participant has to experience difficulties performing the chosen tasks. Learning the correct execution of these (i)ADL tasks will be the main aim during the rest of the training sessions. Acceptable treatment goals are those which can be subdivided into multiple steps and should be defined in accordance with the SMART method (Specific, Measurable, Attainable, Reasonable, Timely)
]. After the second session a baseline assessment will take place. The execution of both treatment goals will be filmed, so that it can be evaluated later by assessors who are blind for allocation. After the baseline assessment participants will undergo training sessions 3–8 in the errorless learning condition or in the trial and error condition.
Content of GMT sessions for both treatment arms
GMT-errorless learning condition
The experimental treatment consists of GMT with an errorless learning approach, i.e., both the acquisition and application of GMT will be taught using error controlling methods. This implies active guidance from a therapist to prevent the occurrence of errors or guessing. Therefore, errorless learning techniques, such as verbal instructions, modeling and cue cards will be used, as well as written instructions of the chosen (i)ADL tasks. After the two tasks have been subdivided into multiple steps and have been rehearsed verbally during sessions 3 and 4, the actual execution of these steps is practiced in sessions 5 and 6 of the treatment. In these sessions cues will be faded after successful execution of the steps (i.e., without hesitation or errors). In sessions 7 and 8 the patient will be taught to check after each task step if the action was performed correctly and if it has led to the planned (subordinate) goals. ‘Checking’ is part of the final stage of the GMT algorithm and therefore both treatment goals will be fully integrated into the GMT algorithm and errorless execution of both complex tasks according to the GMT algorithm will be practiced.
GMT-trial and error learning condition
In the conventional GMT errors are allowed to occur. Patients will learn to use the GMT algorithm and the performance of the tasks using trial and error learning. In this condition the therapist is not required to prevent errors during the application of the GMT strategy, but he/she only provides feedback in response to errors (i.e. afterwards). Also, therapists will not provide clues as how to solve problems and will not actively prompt or guide the execution of tasks. After having chosen two (i)ADL tasks in sessions 1 and 2, session 3 consists of a general description of the GMT algorithm by the therapist. In sessions 4 and 5 the participant is asked to define the task steps and- complete the GMT schemes for both treatment goals. The therapist will not help in defining the task steps and the main aim is to motivate the participant to complete the schemes. If errors occur, the therapist will not intervene, and the participant will have to detect these during the training. In sessions 6 and 7 the actual performance of the (i)ADL tasks will be practised, again using the above described trial and error approach. The participant will be motivated to actively practice performance and to seek solutions in the case of problems. Session 8 is again devoted to the execution of the tasks and to eventually improve the execution of task steps or the previous completed GMT schemes.
The primary objective of this investigation is to examine the efficacy of a combined errorless learning and GMT intervention for the treatment of executive problems in patients with acquired brain injury (ABI). These patients are in the chronic phase of their illness and the study will focus on individually chosen complex daily tasks ((i)ADL), such as cleaning a bathroom, processing mail or preparing a meal. The hypothesis is that brain-injured patients will (re)learn performance of (i)ADL tasks more efficiently if an errorless learning method is used. That is, more task steps will be performed correctly and in the right sequence and less irrelevant and missing steps will be present. Consequently, more goals and sub goals will be attained by applying errorless learning in GMT.
An overview of the outcome measures is given in Table
. The main outcome will be (i)ADL task performance. Performance of each task step will be scored on a 3-point scale: 0) absence/incomplete
: the task step is missing or incomplete; 1) questionable/ineffective
: the task step is not correctly performed or not set in the correct sequence; 2) competent/correct
: the task step is successfully performed and set in the correct sequence. Observed total scores will be converted into percentage scores to allow statistical comparison of data from different (i)ADL tasks, and comparison between groups. A similar scale was used in previous research
] to assess (i)ADL task performance in patients with Alzheimer’s dementia. Task execution will be filmed and evaluation by using the scale will take place afterwards by an assessor who is not involved in the actual treatment to secure the blind nature of the design.
Recruitment- and outcome variables
A secondary outcome measure will be goal attainment using Goal Attainment Scaling (GAS)
]. GAS is an individualized method to evaluate the extent to which individual treatment goals are achieved by defining several levels of outcomes (‘as expected’, (much) more than expected, (much) less than expected). GAS is scored in a standardized way to allow statistical comparisons between individual treatment goals and is widely used in rehabilitation
]. During session 2, GAS schemes for both treatment goals will be completed by the trainer in cooperation with the participant. During the post-treatment measurement, two GAS scores will be obtained, one by the patient and one by the trainer.
Additional study parameters
Questionnaires will be administered to measure several aspects of executive functioning. The Dysexecutive Questionnaire (DEX)
], both the patient and the proxy version, will be used for the assessment of dysexecutive behaviour. Self-reported executive functioning will be measured using the Dutch version of the Executive Function Index (EFI-NL)
]. The Executive Observation Scale (EOS) (based on Pollens
]), completed by a proxy, will be used as an observation measure for executive function. The Cognitive Failures Questionnaire (CFQ)
] will assess self-reported subjective cognitive complaints in general. Quality of life will be determined using the RAND 36-item Short Form Health Survey (RAND-36)
After the second session, in which two individual treatment goals ((i)ADL tasks) are established and the GAS schemes are completed by the trainer in cooperation with the participant, the baseline measurement will take place. During this assessment execution of both treatment goals will be filmed to secure the blind nature of the design. The recorded performance will be assessed by an independent research assistant using the standardized scale to guarantee blinding of condition.
After treatment, (i)ADL task performance will be assessed again by filming and scoring task performance. The previous completed GAS schemes will be scored by participant and by trainer to evaluate goal attainment. The questionnaires and neuropsychological assessment, using parallel versions of the same tests, will be administered after treatment as well, to control for nonspecific recovery. The data gathered with the questionnaires and the neuropsychological tests provide measures for change in insight, executive complaints, subjective and objective executive functioning for moderator analyses, to examine possible determinants for treatment success.
Determination of the sample size for this study is based on data from a RCT examining the effects of a structured 6-week Goal Management Training
]. In each group 32 participants are required to detect an effect size of d=
.6 with a power
.80 and α.
05. These estimated sample sizes are comparable with other studies evaluating the efficacy of different types of GMT
Randomization and blinding
Allocation of participants to either condition will be established using a computer generated block randomization procedure (block size n
4) without stratification. The written information to inform patients about the study only mentions that two types of GMT will be compared. To achieve participant blinding, no information will be given about specific differences between the two conditions. Assessor blinding will be achieved by filming the (i)ADL task performance of the participants. All hints of treatment condition will be avoided and performance will be scored by research assistants who are not involved in delivering GMT.
All data will be analyzed with IBM SPSS 19. The normality of all variables will be checked and corrected for, if necessary. The performance on the neuropsychological tests will be compared with normative data and corrected for age and education. Descriptive statistics of relevant variables will be obtained and compared for the two treatment arms using analysis of variance.
To evaluate the efficacy of GMT-errorless learning compared to conventional GMT with trial and error learning, pre- and post training data will be analyzed using a 2
2 repeated measure analysis of variance (General Linear Model) with treatment condition (GMT-errorless learning and conventional GMT) as between-subject factor and measurement (pre- and post-treatment) as within-subject factor. The dependent variable will be the standardized scale score (quantitative). The same analysis will be done for the secondary outcome measure, the GAS scores. Appropriate post-hoc tests will be performed and effect sizes (partial eta-squared) will be computed. Moreover, correlations will be computed between moderator variables (questionnaires and neuropsychological tests) and treatment effects (difference score: post treatment minus baseline).
The background variables of the participants in both treatment conditions are expected to be comparable (age, education level, estimation IQ) because of the randomization procedure. In case of significant differences, appropriate statistical adjustment for confounding variables will be performed (ANCOVA). All statistical tests will be two-tailed, alpha set at 0.05.