The aim of this study is to investigate the feasibility of a computer-based cognitive training (working memory training) in a relative old and cognitive impaired population of MCI patients. We will examine the effect of this cognitive training on…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Mild dementia/Mild cognitive impairment (MCI)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility
Feasibility will be evaluated on the basis of (a) age, (b) patient*s
abilities/capacity (daily investment, duration and difficulty level of the
tasks and questionnaires), and (c) weakly (or daily) telephonic conservations
between the researchers and the patient or his/her partner/caregiver. In
addition, the (possible) lack of computer skills and the necessity of an
involved partner/caregiver are also important factors to consider in regard to
the feasibility
Accomplishment of the WMT, excluded subjects and dropouts
The number of participants that accomplish the whole WMT (25 days), the number
of excluded subjects (e.g. by the researchers) and the number of dropouts will
be recorded.
The researchers will try to contact withdrawn subjects, in order to clarify,
whether his or her reasons were related to experimental set up. Subjects are
not obligated to give the reason why he or she has stopped with the experiment.
These outcome measurements can give us crucial information about the applied
intervention and the investigated population
Secondary outcome
WM capacity
WM capacity will be measured with using the same tasks that will be used during
the WMT. However, the assessment versions of the three tasks will end when
participants are unable to reproduce a sequence of two consecutive trials. The
outcome measure for each task will be the length of the longest sequences that
participants correctly reproduce on two consecutive trials. See section 3 for
detailed information about the WM tasks.
WM (equal, but not trained task)
The Backward letter span will be used to function as a control WM task. This
means that this task is equal to the other WM tasks, but that it not will be
trained. During this backward letter spa task, a sequence of letters will be
presented on the computer screen. Participants have to reproduce this sequence
in reversed order, using either the computer mouse or the letter keys on the
keyboard. This task is added to the present study to see whether the
participants show an improved WM performance on only the trained WM tasks or on
all WM tasks (including the not trained task). By this way, we can chart the
(generalization) effect of WMT.
Consequences of WM deficits in everyday life.
The Working Memory Questionnaire (WMQ) is a self-administered scale, addressing
three dimensions of WM: short-term storage, attention, and executive control.
The WMQ assess the consequences of WM deficits in everyday life (Vallat-Azouvi,
Pradat-Diehl & Azvouvi, 2012). The WMQ consist of 30 items and each question
will be rated on a five-point Likert-type scale, ranging from 0 (*no problem at
all*) to 4 (*very severe problem in everyday life*). Examples of items are:
**Do you find it difficult to remember the name of a person who has just been
introduced to you?** and Do you feel that fatigue excessively reduces your
concentration?**. This questionnaire is added in the present study to monitor
the everyday WM problems of our participants.
Executive functioning (non-equal task)
A computerized version of the Stroop task (Stroop, 1935) will be used to
measure information processing speed and susceptibility to interfere.
Participants have to respond in the first block as fast as possible to four
coloured (blue, red, green and yellow) words (**Blue**, **Red**, **Green** and
**Yellow**) by using the number keys on the keyboard. During the second block,
participants have to respond to the colour (blue, red, green and yellow) of the
words (distracters) by using the number keys on the keyboard. This task is
included in the present study to chart the executive functioning performance of
the participants at pre-test, post-test and follow-up and primarily to see
whether executive functioning will improve after WMT.
Cognitive failures
The Cognitive Failure Questionnaire (CFQ; Broadbent et al., 1982; Ponds et al.,
2006) is a self-report questionnaire which consists of 25 items measuring the
frequency of everyday cognitive failures. Each item is rated for frequency in
the past 6 months on a four point scale, ranging from *0* (never) to *4* (very
often). The maximum score is 100. Examples of items are: ** Forgetting
appointments** and ** Forgetting people*s names**. This questionnaire is
included in the present study to monitor the cognitive failures of our
participants at pre-test, post-test and follow-up.
Sense of control
Mastery, or *the feeling as the extent to which a person perceives himself or
herself to be in control of events and ongoing situations* is considered as a
psychosocial resource when coping with stressful life events. A high sense of
mastery is expected to reduce psychological distress and increase well being.
The Mastery-questionnaire (Pearlin, 1978) is used to measure this level of
control that people experience. The Mastery scale consist of seven items scored
on a 5-point scale from **totally agree** (1) to **totally disagree** (5).
Examples of items are: ** Some of my problems I can't seem to solve at all**
and ** Sometimes I feel like a play ball of life**. This questionnaire is
included to the present study to see whether WM effects are independent of
control. One interesting question is for example whether participants with the
lowest improvement in WM performance also have a low level of control.
Self-efficacy
Self-efficacy is defined as the belief that one is capable of performing in a
certain manner to attain certain goals. The Dutch General Self-efficacy Scale
(GSE) consists of 10 statements on a 4-point scale from **totally
incorrect** (1) to **totally correct**. The GSE is designed to assess
optimistic self-beliefs to cope with a variety of difficult demands in life
(Teeuw, Schwarzer & Jerusalem, 1994). An example of an item is: **Whatever
happens, I will manage**. This questionnaire is included in the present study
to monitor the self-beliefs and goals of our participants at pre-test,
post-test and follow-up
Psychological states
The Symptom Check List 90 (SCL-90) will be used as a screening measure of
general psychiatric symptomatology (Buckelew et al. 1988). Patients are asked
to rate the severity of their experiences with each symptom over the past week
on a 5-point scale ranging from 0 (not at all) to 4 (extremely). Examples of
items (or symptoms) are: **Headache** and **Thinking about death or dying**.
This questionnaire is included in the present study to monitor the psychiatric
symptomatology of our participants at pre-test, post-test and follow-up. In
addition, it will also be used to measure the progress and outcome of our
(neuro) psychological intervention.
Background summary
Mild cognitive impairment (MCI) is a condition in which a person and their
environment experience reduced cognitive functioning at a faster rate than is
expected from normal aging. Because the problems do not interfere with daily
activities, the person does not meet criteria for dementia. Research has shown
that individuals with MCI have an increased risk of developing Alzheimer*s
disease (AD) over the next few years. MCI is often found to be a transitional
stage between normal aging and dementia. For this reason, the present study
will investigate whether working memory training can strengthen working memory
and executive control in MCI patients, which may prevent them from further
cognitive decline leading to dementia.
Study objective
The aim of this study is to investigate the feasibility of a computer-based
cognitive training (working memory training) in a relative old and cognitive
impaired population of MCI patients. We will examine the effect of this
cognitive training on working memory performance and executive functioning in a
small clinical sample of MCI patients. We are especially interested whether
this improvement of working memory performance is related to an improvement of
other (non-trained) cognitive/executive functions and cognitive functioning in
daily living.
Study design
We will use a non-blind observational intervention study. The participants will
receive WMT for 25 consecutive days besides the care as usual. Before
(pre-test) and after training (post-test) we will measure WM performance and
executive functioning. After 3 months, a follow-up measurement will take place.
Intervention
The WMT used in the present study is based on the same tasks used in the study
of Houben, Wiers and Jansen (2011). Their WMT was based on the ideas, tasks and
studies of Klingberg and associates (e.g. 2002). The daily exercises are
designed to train both the visuo-spatial and verbal WM. The participants will
perform their WMT program via the Internet on a personal computer (PC). The WMT
includes 20-40 minutes of intense training per day. Participants will follow
the WMT at their own home for 25 consecutive days. (See section 7.3: Study
procedures for further information about the several sessions of the WMT)
Participants will be trained during the WMT on three kinds of WM tests: the
visuospatial WM span task, the backwards digit span task, and the letter span
task (based on Klingberg, Forssberg & Westerberg, 2002).
•Visuospatial WM task: during this task, a certain number of squares in a 4x4
grid changed in colour on the computer screen. Participants have to reproduce
this sequence by clicking on the squares that have changed colour in the
correct order using the computer mouse.
•Backward digit span: during this task, a sequence of numbers will be presented
on the computer screen. Participants have to reproduce this sequence in
reversed order, using either the computer mouse or the number keys on the
keyboard.
•Letter span task: during this task, a sequence of letters will be presented on
the computer screen in a circle. One of the positions in this circle is to be
indicated and participants have to reproduce the corresponding letter using the
keyboard.
Participants must follow 30 trials of each of the three WM tasks. This means
that they have to solve on a daily basis 90 WM exercises for 25 consecutive
days. The difficulty level of all three WM tasks will be automatically adjusted
on a trial-by-trial basis. The training is adaptive; WM load is increased
according to each individual*s performance levels. Initially, each task
involved sequences of three items. The length of the sequences will increase
and decrease according to participants* performance. When participants
correctly reproduce the sequences on two consecutive trials, one item will be
added to the sequence on the next trial. When participants are not able to
correctly reproduce the sequences on two consecutive trials, the sequence in
the next trial will contain one item fewer. This automatic adjustment makes the
training easier or more difficult. Every participant trains on his/her optimal
WM capacity.
Study burden and risks
The risk of participating in this study are considered minimal. The working
memory training and questionnaires are non-invasive
and scarecely stressful, When taken into consideration that the participants
have to be mental competent to give informed consent and the risks of
participating in this study are minimal, we feel that the burden of
approximately 40 minutes for 25 consecutive days are justified, in order to
gain more insight in the relationship between working memory and mild cognitive
impairment/mild dementia.
Dr. P. Debeyelaan 25
Maastricht 6229 HX
NL
Dr. P. Debeyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
MCI: diagnosed according to the criteria of the DSM IV-R (American Psychiatric Association, 2000);Age over 18 years;A minimum of 4 years of formal schooling and no history of mental retardation;Native Dutch speaker;Mental competency to give informed consent. Mental competency as defined by the Dutch law (WGBO: Wet of Geneeskundige Behandel Overeenkomst) is determined by the medical specialist (psychiatrist, neurologist).;Participants must have access (preferable at their own home) to a computer with an internet connection. ;Participants must have some experience with computers (preferable with Windows and Internet Explorer).;A partner/caregiver who is willing to help/assist the participant with the daily computerized training.
Exclusion criteria
History of acquired brain injury (e.g. cerebral contusion, cerebrovascular accident)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
Other | Nederlands Trial Register (TC = 3476) |
CCMO | NL41179.068.12 |