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V. M. WESTERBERG
MASSEY UNIVERSITY
MATERS DEGREE
CLINICAL NEUROPSYCHOLOGY
2012
NEUROPSYCHOLOGICAL REHABILITATION MINDFULNESS THERAPY
MINDFULNESS ASSIGNMENT
1.- Title Pg. 3
2.- Abstract 3
3.- Background 3
3.1.- Research objectives 3
3.2.- Research question 4
3.3.- Situation and Justification 4
3.4.- Literature Review 6
4.- Design, Methodology, and Methods 7
4.1.- Operational definitions 7
4.2.- Participants 8
4.2.1.- Sample 8
4.2.1.a.- Inclusion Criteria 8
4.2.1.b.- Exclusion Criteria 8
4.3.- Informed Consent 8
4.4.- Assessment 8
4.5.- Data analysis 9
4.6.- Potential Risks to Participants 10
4.7.- Potential Benefits to Participants and Others 10
5.- Limitations 11
6.- Location of Study 11
7.- Ethics 12
8.- Significance of Research 12
9.- Research Timeline 12
10.- Research Budget 12
11.- References 13
12.- Appendices
Appendix I: Informed Consent template
Appendix II: Swedish Questionnaire 16
Appendix III: Data Safety and Monitoring Plan template
Appendix IV: Low Risk Notification template
Appendix V: Research timeline
Appendix VI: Research budget template
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NEUROPSYCHOLOGICAL REHABILITATION
SINGLE CASE EXPERIMENTAL DESIGN RESEARCH PROPOSAL
1.- TITLE
Mindfulness therapy vs. Computer-based cognitive therapy in a case of severe Traumatic Brain
Injury.
2.- ABSTRACT
The current work aims to shed light to whether Mindfulness Therapy (MT) is useful in cases of
TBI and, if so, whether it is better or not than computer-based cognitive therapy (CBCT) used as
the control condition. It also highlights the need to take an innovative approach to
neuropsychological rehabilitation keeping in mind that, sometimes, a lack of literature about the
topic, as in this case, reflects a lack of publication of results found to be not-significant. An
evaluation of the causes of TBI will be followed by a review of neuropsychological rehabilitation
(NPR) concepts, objectives, methodologies, and applications, to conclude with the evaluation of
Mindfulness Therapy (MT) and its potential benefits in TBI cases. The research design will be
based on Tate et al’s (2008) guidelines for single case experimental designs. The originality of
the study lies in two facts: The almost absence of MT research on TBI cases and the use of the
participant’s early neuropsychological intervention as an additional control condition. The
methodology and methods used are based on the scarce but robust MT research available, with
a focus on the latest technological developments and settings. The results favour the application
of MT late in the rehabilitation process of TBI, with marked improvement in psychological
(anxiety) and neuropsychological (mainly attentional) tests. Useful raw data and tables can be
found in the Appendices.
3.- BACKGROUND
3.1.- Research objectives
A review of the literature has shown a mild but steady growth in MT applications for a holistic
neuropsychological rehabilitation of cases of acquired brain injury like dementia,
cerebrovascular disorders, encephalitis and TBI. Because in today’s society technology is
changing how neuropsychological assessment and interventions are done (Thornton &
Carmody, 2008; Yuh et al. , 2008), it was made a key objective of this study to use computer
based neuropsychological tests and to do a comparison between TBI management with MT
(intervention) and with the participant’s previous computer-based cognitive training (CBCT) as
an additional control condition to the individual’s current baseline measurements.
3.1.1. General objectives
Explore the effects of MT on various psychological and neuropsychological variables.
Study the effect of computer-based cognitive training (CBCT) in various psychological
and neuropsychological variables.
Analyse the differences in the effects of MT and CBCT on the psychological and
neuropsychological variables assessed.
3.1.2. Specific objectives
Explore the effect of MT on measures of depression, anxiety and health.
Study the effect of MT on measures of full attention in activities of daily life (ADL).
Examine the effects of MT on measures of executive functioning.
Explore the influence of CBCT on measures of depression, anxiety and health.
Study the effects of CBCT on measures of full attention in activities of daily life.
Examine the effects of CBCT on measures of executive functioning.
Analyse the differences in the effects of MT and of CBCT in every one of the
psychological and neuropsychological variables assessed.
3.2. Research questions
Does Mindfulness Therapy (MT) improve the neuropsychological variables in an individual with
severe TBI based on pre-treatment (baseline) and post-treatment measures?
Was there a difference in the neuropsychological variable effects between the current
intervention, MT, and the previous one, Computer-based cognitive therapy (CBCT) in this case
of severe TBI?
3.3.- Situation and Justification
3.3.1.- Traumatic Brain Injury
Traumatic brain injury (TBI) is a form of Acquired Brain Injury (ABI), that is, injury caused by
damage to the brain not due to congenital reasons. ABI can result from “strokes, tumours,
toxins, degenerative diseases, brain haemorrhages” (Christchurch Memory Clinic, 2012, n.p.)
from a ruptured aneurysm or hypertension and from external trauma to the head. The most
common cause of TBI are motor vehicle accidents (MVA) in developed countries. In New
Zealand (NZ) the incidence and prevalence of MVA injuries (including drivers, passengers,
pedestrians, and cyclists) has risen despite media campaigns and road and vehicle safety
improvements from 10,962 in 2006 to 38,200 in 2010. (Te Ara, 2012). The male:female ratio of
TBI, regardless of ethnicity, is 4:1 and it fluctuates with age with two peaks: one during the 20’s
and another in late adulthood. The costs of MVA are many: loss of lives, loss of autonomy due to
physical and/or mental disability and loss of job, reduced quality of life, and medical, legal, and
property damage costs (Ministry of Transport, 2012).
TBI results in mental status impairment ranging from confusion and amnesia, to loss of
consciousness, vegetative state, and death (PubMed Health, 2012). Individuals with TBI show
variable neuropsychological outcomes that depend on factors like age, the severity of the
trauma, the causating mechanis, the type of brain damage, size and location of brain injury, the
subject’s premorbid characteristics, and severity of trauma (Leathem, 2012). The World Health
Organization (WHO) (2006) established a grading system for TBI based on the Glasgow Coma
Scale (GCS) which ranges from 3 (worst) to 15 (best):
• Mild TBI: Loss of consciousness (LOC) under 15 minutes and a post-resuscitation GCS of 14-
15.
• Moderate TBI: LOC over 15 minutes and GCS of 9-12.
• Severe TBI: LOC over 6 hours and GCS of 3-8.
The changes produced after a TBI are complex and persistent over time (Leathem, 2012). These
changes not only affect directly injured neurons, but also remote areas of the injury through
mechanisms such as the neuronal degeneration, neurochemical alterations, edema, increased
intracranial pressure, and vascular integrity disruption due to hemorrhage or ischemia (Zasler,
Katz, & Zafonte, 2007). TBI follows a generally improving trend over time follows a progressive
course which is faster between the third and sixth months after which improvement continues
slowly in subsequent years (Kreutzer, DeLuca, & Caplan, 2011).
Emotional disturbances and personality changes after a TBI are relevant factors responsible for
the social insertion limitations affected individuals face (Leathem, 2012). Regarding changes in
personality, these can range from a mild exacerbation of some previous features to a radical
change of premorbid personality. Personality changes are the main cause of complaint and
reason for consultation by TBI family members (Prowe, 2011). The most frequently reported
personality changes range from apathy to disinhibition, with characteristic irritability,
frustration intolerance and egocentric (childish) behaviour (Prowe, 2011; Kreutzer, DeLuca, &
Caplan, 2011). All these issues raise the need for a NPR approach of individuals with TBI from a
perspective that encompasses as many of the mentioned affected areas as possible.
3.3.2. Neuropsychological Rehabilitation (NPR)
NPR is best done from a holistic point of view, one that is not confined to just cognitive
stimulation, but one that also covers the emotional, family, social, occupational, and all other
cognitive-behavioural problems that affect individuals with TBI (Babbage, 2012; Ben-Yishay &
Diller, 2011). Therefore, the main objectives of a NPR programme should be: (1) to provide a
model that helps the individual and his family understand what happened, (2) to help the
individual cope with brain damage in his life providing training strategies and abilities to
recover and compensate for cognitive, behavioural and social deficits, (3) to promote realistic
goals and hope (Ben-Yishay & Diller, 2011).
NPR programmes must be individually designed and applied, even when patients’ data may be
considered together for research purposes. Such programmes should focus on the needs of each
person as detected during the neuropsychological assessment/s. The efficacy of NPR treatment
depends on its individualisation, precocity and intensity of intervention (Leathem, 2012;
Kreutzer, DeLuca, & Caplan, 2011).
Ever since their identification in 1946 by psychologist Oliver Zangwill and speech therapist
Edna Butfield, the following basic strategies are used in NPR programmes (Wilson, Gracey,
Evans, & Bateman,2009; Ben-Yishay & Diller, 2011; Kreutzer, DeLuca, & Caplan, 2011):
- Restoration: Stimulation and repeated exercise of the function altered so as to regain it, even
if partially, based on neuronal regeneration capacity (Wilson et al., 2009; Kreutzer, DeLuca, &
Caplan, 2011; Thornton & Carmody, 2008).
- Compensation: Use of techniques and external mechanisms to function effectively despite
impairment (Babbage, 2012; Thornton & Carmody, 2008). This approach promotes the
replacement of the function by means of functional reorganization. In other words, healthy
brain regions assume the function of the damaged ones (Wilson et al., 2009).
Unfortunately, the effects of these strategies are usually small and specific to the trained tasks,
with no generalization to other skills (Ben-Yishay & Diller, 2011; Wilson et al., 2009). One way
to enhance generalization is introducing further strategies like metacognitive training in which
the individual internalises a number of useful strategies to monitor and manage his behaviour
(Sohlberg & Mateer, 2001), external aids to reduce the involvement of the cognitive processes
affected in everyday activities through the use of tools like diaries, recorders, and alarms
(Babbage, 2012), and changing the environment to eliminate barriers and distractions.
3.3.2.1.- Mindfulness: A new approach to neuropsychological rehabilitation.
A disciple of Nobel prize laureate in Medicine, Salvador Luria, professor Jon Kabat-Zinn (2011)
of the University of Massachusetts created the Mindfulness-Based Stress Reduction (MBSR)
programme as a treatment form for chronically ill individuals in 1979. His later called
Mindfulness Therapy (MT) comes from third generation therapies (3GPT) that stem from
modern Clinical and Health Psychology (Hayes, 2004). In most of his latest case studies MT
addressed emotional problems like anxiety and depression, and psychological conditions like
post-traumatic stress disorder, pain management, and somatization problems (Kabat-Zinn,
2011). However, the growth in recent years of research applying this therapy has encouraged
some authors to consider MT as a potentially useful strategy in the treatment of a condition like
TBI that requires the training of full attention and concentration.
Mindfulness means consciousness or conscious-being (Kabat-Zinn, 2005). MT as described by
Kabat-Zinn is a Zen-based 3GPT perspective that opposes the hedonist approach to pain and
disability of modern Western therapies (Zabat-Zinn, 2005, 2011). MT promotes focused
attention and full awareness of the present moment in an uncritical manner. Ever since in 1982
Prof Zabat-Zinn published the first of a series of research studies about MBSR, which he later
called MT, about 51 patients with untreatable chronic pain, hardly a single year has passed
without there being new studies carried out and published about the health benefits of MT.
Chinen (1988) used MBSR to analyse the meaning of “understanding” diseases and patients
among medical doctors. Moore (1998) showed how MT was beneficial in the treatment of
different physical and psychological conditions. Connelly (1999) used MT to improve physicians
attention to tasks, reduce stress and promote a more humanistic patient care. From Shapiro
(2001), Williamson (2003), Cohen-Katz (2004) and Santorelli (2007) to the most recently
published articles by Rakel, Fortney, Sierpina, and Kreitzer (2011) and by Sauer, Lynch, Walach,
and Kohls (2011), evidence shows that the effectiveness of MT in the coadjuvant management of
pain, stress, suicidal behaviour, anxiety disorders, depression, bulimia, anorexia nervosa, and
some addictions.
In view of the literature, further research is needed to determine the mechanism through which
MT activates the brain, promotes positive affect, reduces negative experiences and promotes a
faster recovery.
With regard to MT for the management of TBI, very few studies have been published about the
topic and the results have been mixed. Whereas McMillan et al. (2002) carried out a well-
designed RCT for the management of attentional deficits in patients with TBI and found non-
significant results, Bedard et al. (2003) found MT helpful with overall cognitive rehabilitation
and locus of control, and so did Azulay, Smart, Mott, and Cicerone (2012) with quality of life and
self-efficacy.
Looking at the differences and similarities of effects of MT vs. CBCT, both approaches have been
shown effective in the improvement of attention deficits (Tang & Posner, 2009). However, there
is debate about which area of attention is trained by each intervention, if states or traits, a point
which will be discussed later in the results section. Another relevant issue is the phase of the
neuropsychological rehabilitation process at which each intervention should be applied. CBCT is
considered a strategy for the early stages of a restorative intervention (Thornton & Carmody,
2008; Yuh et al., 2008). By contrast, MT, although it could also be employed in the early stages,
because it is important that the patient have some level of awareness of the disease, application
at a later stage as a compensatory, metacognitive, strategy is preferable (Bedard et al., 2003;
Azulay, Smart, Mott, & Cicerone, 2012). These interventional considerations were considered
and applied in the current experiment.
4.- DESIGN, METHODOLOGY, AND METHODS
As mentioned previously, MT has been successfully applied not only in coping with various
psychosomatic problems, but also in the training of concentration and attention. As a
metacognitive strategy, MT has been effective in controlling and monitor TBI patient’s
behaviour, especially those who are in the final stages of NPR . It should be kept in mind that the
emotional, personality, and behavioural issues derived from TBI are essential when designing
the NPR process (Leathem, 2012).
5.2. DESIGN
Single-case experimental designs are patient-customised interventions that allow data to be
evaluated first individually, so that individual differences can be assessed, and then collectively,
therefore, improving the external validity of the experiment. In this case, an A-B-A design was
used. The procedure took place over a period of 4 months:
Month 1: Four blocks of two, 45-minute sessions, with a 1-hour break in between, once-a-week,
were used as baseline measurements (pre-test condition). Two researchers took turns in the
evaluation.
Month 2: Application of the intervention, MT, with 45-minute daily sessions over a period of 4
weeks. The data will be referred to as the treatment condition.
Month 4: Post-treatment evaluation was conducted 4 weeks after the last MT intervention to
assess the new baseline. The procedure is the same as the pre-test one.
The dependent variables are quantitative scores on the questionnaires, the scores obtained with
the battery of computerised tests for the evaluation of different executive components, and
weekly records. The independent variables are the A-B-A conditions.
5. METHOD
5.1. PARTICIPANTS
Inclusion criteria for consideration in the study were: Being over 18 years of age, having been
diagnosed with moderate to severe TBI, being in the final phase neuropsychological
rehabilitation, functional and anatomical integrity of upper limbs, have English as mother
tongue, and voluntary acceptance to participate in the research through the signature of
informed consent (see Appendix 1).
Exclusion criteria were: History of psychiatric or neurologic disorder, having consumed alcohol
or drugs in the 12 hours prior to the evaluation, and having sensory deficits (visual, acoustic,
tactile).
CASE STUDY
JS is a 28-year-old, right-handed, NZ Pakeha, single male, with incomplete secondary studies,
who suffered a traffic accident 20 months ago when he was in the company bus on his way to
work in the mine. He was diagnosed with severe TBI (initial GCS of 6), multiple fractures, and
his right foot had to be amputated on site. He remained in a coma for 72 hours and suffered PTA
for 7 days. The initial MRI examination showed bilateral frontotemporal hemorrhage (R > L),
diffuse subcortical petechiae, and mild cerebral edema. After being discharged from hospital
and a period of standard physical and computer-based cognitive rehabilitation, the patient went
to his GP complaining of considerable inability to maintain attention for more than a few
minutes, memory problems (forgets names or how to go back home), apathy, inactivity,
irritability and low mood. He is off work and his professional future is uncertain. His mood
fluctuates daily between anxiety and depression, but he never feels “normal” like in the past. He
no longer feels like going out at all. Before the accident he used to go out and drink “moderately”
on weekends (4 drinks / night). He stayed “dry” during weekdays as there was frequent random
alcohol testing at work. Now he says his alcohol consumption has increased to 3-5 beers a day,
most days. On physical examination, his visual, auditory, and somatosensory abilities are
preserved. He accepted being tested for alcohol for participation in this study and signed an
informed consent in the presence of his mother.
5.3. MATERIALS
Among the materials used are the informed consent, which was completed and signed by each
participant (see Annex 1), a PC with the computerised version of the tests below, and five
questionnaires printed on paper that evaluated psychological variables. Other materials used
were: computers for the application protocol and executive function for the projection of
PowerPoint presentations (in group Mindfulnes) Audiovisual materials Mindfulnes sessions,
tables and chairs for the same session; CD's and paper records, for the practice of exercises
Mindfulnes at home.
The computer-based baseline-assessment protocol was designed to systematically evaluate the
main components of executive functioning in a single session. It included well-validated test
batteries evaluating encoding , maintenance and updating of information in the working
memory; motor inhibition and inhibition of irrelevant stimuli, task and attention shifting and
task planning (Thornton & Carmody, 2008; Yuh et al., 2008). The assessment battery consisted
of the following tests in an order so that the more engaging tests are interspersed between more
difficult ones (Gammon, 2012):
1.-Sternberg short-term memory test: This test assesses the capacity to code and maintain
information in the working memory (REF). The task presents the subject a set of between 3 and
9 consonants for between 3 and 9 seconds on the first screen, and after a delay of 3 seconds, one
of those consonants is presented on a second screen. The participant has to identify if a given
consonant was presented or not on the first screen. The consonant remains fixed on the screen
until the subject gives the response. To select a response, the participant has to click on one of
the two symbols on the screen: The green tick sign for a “YES” response or the red “x” sign for a
“NO” response. Of the 56 test trials, 8 trials for each length of the row of consonants (from 3 to
9) are presented at random. The task consists of six practice trials and 56 trial tests. Of the 56
test trials, half of them (28) require an affirmative answer, whereas in the other half the
response is negative.
2.-Computerised version of the Tower of Hanoi: This task assesses planning and problem
solving processes (REF). It involves goal setting, mental rehearsal, implementation and
evaluation of the strategy chosen to achieve the goal based on the ultimate success or failure.
The test consists of a total of 10 trials. In each trial, the participant has to perform a series of
movements with the mouse to place the 4 coloured discs in the same position as in the model,
taking into account a set of rules, like, for example, that a larger disc cannot be placed on top of a
smaller one.
3.-N-back task: This task assesses working memory information-processing updates (REF). The
subject is presented with a series of stimuli and s/he must state which stimulus is exactly like
another presented “n” positions before. This protocol used a 2-back task (average difficulty).
That is, if a participant is presented the following sequence on the screen: K-P-M-B-M, s/he
should answer "YES" (pressing the "y" key) when the letter M appears for the second time,
whereas in the rest of consonants in the series the answer will be "NO" ( pressing "n").
4.-Number-letter pair task: This test evaluates the ability to change from one mental setting
(cognitive criterion) to another -an important aspect of executive functioning (REF). The
participant is presented with a number and a letter (e.g.: 3 G) in one of four quadrants of a table
in the centre of the screen. The explanation of the task specifies that when the number-letter
pair appears in one of the two upper quadrants, s/he will have to indicate whether the number
is odd or even, but if the number-letter pair appears in any of the two lower quadrants, s/he has
to indicate whether the letter is a vowel or a consonant. The task consists of three blocks of
trials. In the first one (12 practices and 36 tests), the number-letter pair is always presented in
one of the two upper quadrants. In the second block, the number-letter pair always appears in
the lower quadrants. And, in the third block the number-letter pairs may appear in any
quadrant. The third block consists of 128 trials and in half of them the participant has to switch
from one task to another. The cost-effect of changing tasks is calculated with the formula :
average reaction time (RT) in the third block minus average RT in blocks 1 and 2.
5.-Stroop Test: This test assesses the capacity to inhibit irrelevant responses for the required
task (REF). The participant has to name the colour in which the words appear on the screen.
These words, in the computerised version are shown one at a time in the centre of the screen.
To successfully complete this task, participants must attend the relevant dimension word
(colour), while ignoring or inhibiting the irrelevant dimension: the meaning of the word. The
Stroop interference effect is obtained comparing participants results in the incongruent
condition (e.g., the word PINK written in black) with the results obtained in the neutral
condition of meaningless stimuli (like a set of Xs).
6.-Go-NoGo task: These tests measure the capacity of the subject to inhibit motor functions
(REF). In this test, the subject has to inhibit a particular response, which had previously been
automated. The task begins with 12 practice trials and then 80 test trials. The time interval
between trials varies at random from 250 to 2000 ms. In each trial, the centre of the screen
shows a letter. The subject has to respond as fast as possible (pressing key "n") in those trials
which a letter different from say "T" is presented ("GO" trial). The participant should not
respond ("NoGo" trials) in those cases in which the letter "T" appears. There are 60 Go-trials
and 20 NoGo-trials.
7.-Computerized version of the Iowa Gambling Task (IGT): This test assesses the decision-
making process (REF). The task is a card game in which the subject has to lift a card every time
from four different decks (A, B, C, and D). With decks B and D varying amounts of points can be
gained, with an average gain of 60 points per letter, and varying amounts can be lost with an
average loss of 252 points (advantageous decisions). However, with decks A and C quantities
are won whose average is 115 points per card and an average loss of 68 points (no
advantageous decisions). The task ends once 100 cards have been turned. In each of the
experimental conditions of each task, the reaction time and error rates are automatically
recorded.
8.-Attention Network Test (ANT): The ANT evaluates three components of attention: attention,
orientation and executive control. This test is designed to try to measure in a short, single
experimental session the independent functioning of the three attentional networks as well as
the possible interactions between them (McLeod, 2009). This task can be applied to people of
different ages (adults, children) and to clinical and neuropsychological populations because it
does not require any specific knowledge and is not influenced by the cultural level of the
participant. As a speeded choice task, the ANT provides two measures of performance, response
time (RT)and error rate (ER), and the three network scores are calculable within each of these
measures The test is about observing and discriminating the direction of an arrow (target) that
is always flanked on both sides by other arrows (distractors) that point to the same direction
(congruent) or to the opposite direction (incongruent) as the target. This set of arrows appears
above or below a central fixation point and is preceded by a signal (an asterisc) that can appear
above or below the fixation point (in which case it offers 100% valid information about the
location of the arrows), in the centre of the visual field (non-informative centre signal
condition), or on both sides of the fixation point (non-informative double signal condition).
There are also some trials in which the arrows are not preceded by any signal.
McLeod, J.W. (2009). Psychometric Considerations of the Attention Network Test. 1Jan THESIS.
McMaster University. Retrieved from http://digitalcommons.mcmaster.ca/open_diss/
Finally, when comparing the RTs obtained in the different experimental conditions it is possible
to calculate 3 scores or numeric indices, which correspond to the networks of alert, orientation
and executive control. The alert network score is obtained by comparing the RT of the "no-
signal" and "dual signal" conditions. The punctuation-network corresponding to the orientation
is obtained comparing the RT signal conditions "central" and "signal space".
The executive network corresponding to the TOR by comparing the conditions "consistent" and
"inconsistent".
Five printed questionnaires were used to evaluate psychological variables. These
questionnaires were:
1.-Kentucky Inventory of Mindfulness Skills [KIMS] (Baer, Smith, & Allen, 2004), the Five Facet
Mindfulness Questionnaire (FFMQ, Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006). FFMQ is
selected by evaluating general tendency to proceed with mindfulness (mindfulness) in the day
to day, since it has proved to have promising psychometric characteristics and would be one of
the best instruments to measure mindfulness to date (May and O'Donovan, 2007), having been
created from the factor analysis of five questionnaires measuring mindfulness. Consists of 39
items with statements about the extent to which they served or not mindfulness various aspects
of daily life. For example: "As I walk I notice the sensations of my body to move." Is answered
with a Likert scale ranging from 1 ("never or rarely") to 5 ("very often or always"). The
punctuation Overall test score is obtained by adding up all Items (see Annex 1). Individuals who
are considered high in the construct which evaluates the test are those who get high scores,
while those with low levels of the construct supposedly should get low scores (Gregory, 2001).
2.-Mindful Attention-Awareness Scale (MAAS; Brown & Ryan, 2003). The reason to include
another questionnaire assessing mindfulness, is the fact that the MAAS seems to emphasize an
element of mindfulness related to the absence of it (mindlessness). This questionnaire is
composed entirely of Items inverse. Thus, Brown and Ryan (2003) demonstrated that direct and
indirect measures of conceptualization of mindfulness were conceptually and psychometrically
equivalent. However, they noticed that the sentences that reflected less mindfulness were easier
to recognize as true, especially for non-meditators, and therefore decided to work with indirect
measures. This latter issue is not trivial, especially considering that in the control group of the
study not meditated. The questionnaire consists of 15 items that are answered with a Likert
scale from 1 ("almost always") to 6 ("almost never"). Because they are posed in reverse, sum of
the scores is interpreted FFMQ same manner, ie, most punctuation greater mindfulness in daily
life activities and vice versa (see Annex 3).
3.-Health Questionnaire SF-36. It was developed in the early nineties in the United States, for
use in the Medical Outcomes Study [MOS]( Ware & Sherbourne, 1992). It grew out of an
extensive battery of questionnaires used in the MOS, which inclulan the 40 health concepts. For
its creation, was selected minimum number of concepts necessary for maintaining the validity
and operational characteristics of the initial test. The final questionnaire covers eight scales
representing health concepts most frequently used in major health questionnaires, as well as
the aspects related to the disease and treatment (physical function, role physical, bodily pain,
general health, vitality , social function, role emotional and mental health.). The generic scale
provides a profile of the health status and has proved a useful tool in the evaluation of the
quality of life related to La (HRQOL) in both general population La eat in specific subgroups. It
is also effective for comparing the load of a variety of diseases, La detect health benefits
produced by a wide range of different treatments and assess the state of health of individual
patients Ware, 2000). This instrument has good psychometric properties, which have been
evaluated in more than 400 articles Garratt, Schmidt, Mackintosh and Fitzpatrick, 2002), which
allow the comparison of results and make it one of the most promising tools in the field of the
HRQL .It consists of 36 items that assess both positive and negative states of health Ia. With
regard to the meaning of La punctuation: the higher, reflecting better health (see Annex 3).
4.-Beck’s Depression Inventory, BDI, (REF) is a classical instrument in assessment of depression
in patients with various health problems . For this study we used the Castilian version 1978 BDI
(Beck Depression Inventory, BDI, Beck, Rush, Shaw and Emery, 1979), validated by Sanz and
Vazquez (1998). The questionnaire consists of 21 items, each of which describes a specific
manifestation of depression , each statement reflects a symptom severity range from neutral to
maximum severity . The numerical values are 0 through 3 respectively. Once coupled
punctuation of all items, interpretation is upstream, the more punctuation more symptoms of
depression (see Appendix 5).
5.-State-Trait Anxiety Inventory [STAI] . It consists of two separate autovaluaciOn scales, which
are used to evaluate two different dimensions of anxiety : La State Anxiety and Trait Anxiety. It
consists of 40 items, which are subdivided into 20 items. For State Anxiety scale measuring
these describe how the subject generally feels (REF). In the measurement of Trait Anxiety,
another 20 statements describe how you feel on the subject at a given time. Subjects respond to
each of the statements of the questionnaire, assessing their responses on a four-point scale. The
four categorlas scale for State are: 1. Not at all, 2. Somewhat, 3. Pretty, 4. Much. And for the Trait
scale category are: 1. Almost never, 2. Sometimes 3. Frequently and 4. Almost always. Subscale
score is obtained both separately summing the 20 Items of each. These scores are interpreted
the same way as the Beck, meaning that increased punctuation smntomas more suggestive of
anxiety (see Appendix 6).
BDI and the STAI questionnaires were not used in this study with diagnostic purposes, but at a
functional level, to explore possible mejorlas after intervention.
Other materials used were: computers for the application protocol and executive function for
the projection of PowerPoint presentations (in group Mindfulness) Audiovisual materials
Mindfulnes sessions, mattresses, tables and chairs for the same session; CD's and paper records,
for the practice of exercises Mindfulnes at home, and finally, the program Award Prime
(Antequera, Daza, Guil, Juarez and Lopez-Crespo, 2009), for scheduling of training activities
computer-aided cognitive.
5.4. PROCEDURE
5.4.1. Assessment pre and post-test
1. Explanatory previous meeting.
Before pre-test assessment, a briefing was done in which they explained the objectives of and
division intervention groups randomly. Also briefly summarized in what was to consist each
intervention and the rotation that would occur after the first treatment, from each intervention
group another. Finally, procedla to the reading of informed consent, a document printed on
paper, distributed to each of them. This debla be signed before becoming part of AI research
(see Annex 1).
In next session, prior to intervention , we proceeded to assessment of executive functions and
psychological variables (see Materials for details). The same evaluation was performed IlevO
after intervention in the post-test.
2. Protocol executive functions.
Both previous briefing in next session protocol was applied executive functions and assessment
of psychological variables, which Ilevaron place in a computer room of the Center for Evaluation
and neuropsychological rehabilitation (CERNEP), of the University of Almerla, where I was
doing the Master's Degree in practicum lntervention in clinical psychological and social.
Administration protocol was 2 45-minute sessions, with a 1 hour break in between, but the
length can vary depending on the degree of involvement of the patient. Some of the tests were
impractical, or by psychological issues, such as the one low resistance to failure by the very well
sequelae of brain damage.
The tests were impractical in the tables with a line box for patient not performed.
3. Evaluation of the quality of life, mood and level of attention in her life target.
The administration of questionnaires assessing psychological variables transcurniO normally in
the same second session. The only exceptions were for smndrome patient with Balint, who had
to point out the lines where I was going, so you do not lose. Occasionally we had to clarify the
meaning of any item, especially those raised in reverse order, especially in the MAAS.
the approximate application of these questionnaires was 30-60 minutes.
5.4.2. mindfulness
First, it should be noted that this study used a shortened version of the four-week MBSR, since
the latter consists of eight weeks. For this reason, the distribution of exercises varies slightly
over the MBSR treatment, although the bulk of the activities and the content addressed are the
same. The only exception are Yoga exercises, which have been excluded from program by the
physical limitations of the patients (for more information on the 8-week program, see, Kabat-
Zinn, 2007).
The treatment used for this research was carried out over a month, with a weekly two-hour
session in a seminar Building Health Sciences University of Almerla . addition site session,
participants were handed a record for home and a CD with meditation exercises for which they
were engaged in their daily environment, after each session (see Annex 7).
It is very important to note that the distribution of the exercises throughout the sessions did not
like a recipe box, but placed in the context of theoretical explanations and tailored to the
individual circumstances of each patient. Furthermore, there are 3 sets a session, while others
are 4. This is because the duration of the exercises uneven, such as body scanning is applied in
about 45 minutes, but for sound meditation may be sufficient with 10, and extension different
explanation of the contents. With elfin to make a brief discussion on the treatment, a brief
description, first, all the exercises used throughout the sessions. Subsequently, detailing which
of these exercises were used in each session.
The exercises were carried out throughout the program:
'Exercise 1: Exercise passes.
is used to explore a mindfulness about the five senses.
- Exercise 2: Seated with sound.
We attend to sounds that occur around us without judgment, including then several songs to
listen without doing anything else.
, Exercise 3: Seated with breathing .
Once that has been practiced briefly breathing exercise (focus attention on breathing) adopts a
sitting upright posture WHILE pay attention to breathing and stomach.
Exercise 4: Body Scan
It scans the body with eyes closed, preferably lying, focusing attention to every part of the body
step by step, to observe the sensations that occur in each area.
Exercise 5: Meditate while you walk.
Walking is paying attention to body movements while performing this action.
Exercise 6: Exercise of emotions.
The five basic emotions will be explored in this order: anger, fear, shame, sadness, and joy.
Finishing the session experiencing joy is expected to leave a feeling of well-being in the
participant. The first four emotions are considered “negative” or undesirable. This exercise aims
to make the participant understand that all emotions are valid and serve a purpose, and that
identifying their presence and possible effects may help the individual with his judgement of a
given emotion in the different situations of daily life.
Emotions can trigger other emotions, masking at times, or can trigger the same emotion. The
primary emotion, is the one triggered by the event. The secondary emotion is triggered by the
primary emotion
The following are the subjects covered in each session:
• Session 1: presentation of the principles of mindfulness and starting from the practice.
Into the first session governing this therapy (see psychological and health were clear from the
outset for example, the difference between allowing performed as a class comment, discuss AI
session.
The basic concepts are explained simply and the benefits of neuropsychological level. Also
possible confusion with other therapies, relaxation and meditation. The sessions are not
lectures, but were interactive, and ask your questions at any time.
Practical exercises and meditation started from this session and were interspersed with
theoretical explanations. Those carried out in this session were:
Exercise 1: Exercise La passes.
Exercise 2: Seated with sound.
> Exercise 3: Seated with breathing Ia.
Exercise 4: Body Scan
Session 2: stress and its management in everyday Ia.
This session will address the content related to stress in everyday Ia: the difference between
acute and chronic stress, the impact on health, the importance of learning to respond rather
than react, etc..
Exercise 5: Meditate walking.
Exercise 3: Seated with breathing Ia. Exercise 4: Body Scan
• Session 3: Models of health and social relations as a source of stress and adaptive resolution.
This session highlights La importance of being attentive and connected to the messages we
send to whether the body is healthy or not.
It also explains the importance of La to La communication styles experience satisfactory social
relations.
Exercise 5: Meditate walking.
Ejerciclo 4: Body Scan.
Exercise 3: Seated with breathing Ia.
Session 4: Coping with the thoughts and emotions and close.
La stands influence the thoughts and emotions in our lives, offering an alternative model more
adaptive coping (La filosofla line with the Third Generation Therapies, see section 3).
Exercise 6: Exercise of emotions.
Exercise 2: Seated with sound
Exercise 5: Meditate walking.
Ejercicico 3: Sitting with breathing.
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6. RESULTS AND DISCUSSION
After post-test assessment Ia, we proceeded to analyze data with SPSS (version 20.0.0).
Because of this study being individualised to a person who suffered from TBI, that is, this being
the smalles sample possible, the emphasis will be put on equally on qualitative as on
correlational and “within-group” data. The most important descriptive data are highlighted in
the section on within-group data, regarding the statistical significance found.
6.1. Qualitative data.
A qualitative analysis -visual and of percentage rates - with the data obtained from the
questionnaires and from the scores on executive functioning tests. The data obtained in the
psychological questionnaires are presented in Table 8 and Table 9. Table 8 shows how the last
two MT sessions reflect an improvement in all the scores, from a poor initial performance. After
CBCT training (the “control” condition), there was no generalised improvements across
questionnaires. Looking at the number of sessions in which there was improvement, Table 9
shows that improvement was higher in the control group Mindfulness that they improved in the
questionnaires that assess mindfulness and LA subscale "Trait" STAI questionnaire . While
there were more people in the control group who improved Mindfulness Group LA subscale
"State" of the STAI questionnaire.
In the tables below, a cross indicates an improvement and a blank means a punctuation like the
pre-test. The orange shading indicates a favourable outcome for MT therapy and the blue
shading indicates a favourable outcome for the CBCT [control] condition.
6.3. Data analysis
The within-group analysis was performed by comparing related samples using Student-t. The
most relevant data are shown in Table 8 in the Trait subscale of the STAI questionnaire as
mentioned in the discussion of cualitative data. In the remaining questionnaires assessing
psychological variables differences were not statistically significant. However, the data were
analysed qualitatively in the previous section.
With regard to the STAI questionnaire, the changes in the scores for MT (from pre-to post) are
statistically, though marginally, significant (p = .058), whereas in the CBCT-control condition no
statistical significance was obtained. It should be kept in mind that the higher the STAI score,
the higher the anxiety. Therefore, a decrease in the score of any of the subscales, especially the
Trait one, is a positive outcome. As noted previously, MT focus on moment-to-moment attention
concentration, which initially requires considerable effort, over time becomes an automatic
habit that requires little effort. This transition reveals that what at first was a state, with
practice, it turned into a trait. The individual may experience anxiety from time to time, but
probably their perception of it varies and the way of dealing with it, which could directly
influence the way the STAI Trait subscale was answered.
This result shows how MT can help in circumstances where full attention is required or when
there are conflicting or complex cognitive tasks to perform. The results found in this study
contradict those found by McMilIan et al. (2002) with regard to their conclusion that MT cannot
modify cognitive variables, only psychological and health ones.
Conclusions:
In view of the results obtained, the following conclusions may be drawn:
MT has been shown useful in the management of a patient who sustained a severe TBI, not just
for the improvement obtained in the psychological measures, but also for that obtained in the
executive functioning ones.
Different cognitive processes may be involved in the MT and in the CBCT, as it appears that the
former promotes greater changes in attention whereas the latter does so on measures of
executive control.
With regard to generalisation –ecological validity- of the results to activities of daily life (ADL)
the data show that MT is a better option for this purpose than CBCT, as active awareness can be
done in any setting, not just in the laboratory. The idiosyncracy of MT means that a new habit,
or life philosophy, will be acquired, which may impact how the individual perceives internal
(bodily) and external (home, family, work, environmental) challenges, and how the individual
ultimately behaves.
Whereas CBCT is harder to generalise to everyday life, such training stimulates useful cognitive
processes of value for the individual.
If the order of interventions were inverted, in a future research, it would be interesting to see
the effect of each one separately, then combined, and then compared with the results obtained
in this work.
Further research may show whether the improvement brought about by MT are long-lasting or
not.
LIMITATIONS
Those of a single case study. Research using a larger sample would increase the power of the
study.
The participant did not always feel good and did not complete every test, which may have an
impact on the statistical significances found.
MT is an abbreviated form of the MBSR treatment. Full application of the latter may reveal a
substantial change in results.
CBCT was not practiced at home, whereas MT was. This circumstance raises the question of
what would have happened to the results of full attention if CBCT had been done at home. This
issue could be tackled in a future study.
4.3.- Informed Consent
Written informed consent (see template in Appendix I) will be obtained to participate in this
study from all participants, who with their signature, will allow the researchers to handle the
data and results obtained as per Massey University and the NZ Psychological Society Codes of
Ethics. In case of conflict, the higher standard of conduct will be observed.
4.6.- Potential Risks to Participants:
A template for a Data Safety and Monitoring Plan can be found in Appendix III. Appendix IV
contains Massey University’s Notification of Low Risk Research/Evaluation involving Human
Participants. Both forms are for the participants to sign. The following two identified potential
risks will be considered (Westerberg, 2012):
First: The participant may find that his answers to some questions may not be socially-
desirable, and, thus, feel uncomfortable . This issue was tackled by informing the participant of
his right not to answer any questions and of his right to withdraw from the study at any time
without consequences.
Second: There is a risk for the confidential information being accidentally released. This
contingency will be dealt with by de-identifying and codifying all data collected, which will be
kept in a locked file cabinet to which only the researchers will have access. With regard to
possible further confidentiality issues, the NZ Psychological Society Code of Ethics will be
observed (Evans, Rucklidge, & O’Driscoll, 2007).
4.7.- Potential Benefits to Participants and Others
The participant will benefit from being aware of his symptoms so that action can be taken to
prevent them from worsening. The participant will also benefit from knowing that his
contribution may help others in his situation. If this research is expanded and replicated
successfully, further funding may ensure that the intervention keeps being implemented.
Knowledge diffusion through presentations in congresses and lectures may capture the
attention and interest of researchers, institutions and the media, so that the public be aware of
how awareness can help the cognitive and executive functioning of individuals with (and
without) TBI.
5.- LIMITATIONS
Limitations of this study start by the potentially small sample gathered, meaning that
participant withdrawals can limit the validity of the results as well as the possibility for
generalisation. The aim is to recruit as many participants as possible to minimise these risks.
Another limitation is the choice of NZ-normed tests, which according to the developers, still
require further studies for further validation purposes. This is how science advances, taking
controlled risks, evaluating results and coming to conclusions. It is expected that the tests will
fare within the limits of acceptability described by the developers. It should not be expected that
every test used here will have the reliability and validity of highly researched tools like the
WAIS-V, although these will be within acceptable limits.
Under-reporting and under-diagnosing for reasons like professional and social desirability are
other potential limiting factors for getting a representative sample. Some individuals may
simply not want to know whether they have VOSN. The researcher has to be persuasive and
explain potential participants the wide range of advantages described in the Benefits section
above.
It has been shown that when p is set at 0.05 in multiple variables studies (>20), statistic
significance is not quite exact, a phenomenon called "multiple comparisons problem" (Coolican,
2009). This is usually solved using Bonferoni's procedure, provided that the tendencies found
are not in the direction of the differences. This issue should not be a problem in this case, as
only 9 tests are being applied.
The researcher is aware of the many unanswered questions regarding VOSN, like the possible
existence of a dose threshold level and interactions with commonly substances and medications.
No experiment can control for all the possible confounds, but every effort will be made to
identify and control possible confounds.
Finally, the provisional timeline provided in Appendix V does not take into account holiday
periods or semester breaks. This limitation would only delay the study some 2 to 3 weeks.
Consultation with the supervisor about holidays will fix this limitation.
6.- LOCATION OF STUDY
Should this research proposal be approved, the study will be conducted at Massey University
Psychology Clinic in Wellington.
7.- ETHICS
Communicating the results to participants will be done during the feedback interview. Because
the results may be used for further purposes like a presentation, a thesis, or a journal article, all
participants will have agreed to this possibility by signing the Informed Consent. The NZ
Psychological Society Code of Ethics (Evans, Rucklidge, & O’Driscoll, 2007) will be the reference
to follow throughout and beyond the duration of the experiment.
8.- SIGNIFICANCE OF RESEARCH
The relevance of this research proposal lies on the lack of recent studies about VOSN in New
Zealand. Of particular significance is the fact that this proposal aims to use NZ-normed tools
instead of the US-validated ones recommended by the NZ Department of Labour since 1992
(DOL, 1998). Validation of new, useful tools and studies rely on researchers taking controlled
risks and time to apply them, as in this case.
Additionally, this work proposes the novel idea of the need to develop an assessment and
diagnostic software for regular, early, fast detection of neurotoxicity due to occupational organic
solvent exposure that would lead to the production of large numbers of data to create a VOSN
longitudinal study in New Zealand.
9.- TIMELINE
A provisional timeline is described in Appendix V and implies full-time dedication for a
minimum of one year.
10.- BUDGET
Appendix VI contains the Research Proposal Budget Template to be filled out with the
assistance and input of the main supervisor, based on her experience.
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Appendices:
Informed consent
BDI http://www.ibogaine.desk.nl/graphics/3639b1c_23.pdf
STAI www.reginfo.gov/public/do/DownloadDocument?documentID
SF-36
Kentuky KIMS
MAAS
Registry of home exercises
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