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Pilot evaluation of a mindfulness-based
intervention to improve quality of life among
individuals who sustained traumatic brain
injuries
MICHEL BE
´
DARD{{*, MELISSA FELTEAU{,
DWIGHT MAZMANIAN{, KARILYN FEDYK}, RUPERT KLEIN{,
JULIE RICHARDSON}, WILLIAM PARKINSON} and
MARY-BETH MINTHORN-BIGGS{
{ Lakehead Psychiatric Hospital, Ontario, Canada
{ Lakehead University, Ontario, Canada
} Canadian Paraplegic Association, Lakehead University, Ontario, Canada
} McMaster University, Lakehead University, Ontario, Canada
Accepted for publication: January 2003
Abstract
Primary objective: To examine the potential efficacy of a
mindfulness-based stress reduction approach to improve
quality of life in individuals who have suffered traumatic
brain injuries.
Research design: Pre-post design with drop-outs as controls.
Methods and procedures: We recruited individuals with mild to
moderate brain injuries, at least 1 year post-injury. We
measured their quality of life, psychological status, and
function. Results of 10 participants who completed the
programme were compared to three drop-outs with complete
data.
Experimental intervention: The intervention was delivered in
12-weekly group sessions. The intervention relied on insight
meditation, breathing exercises, guided visualization, and
group discussion. We aimed to encourage a new way of
thinking about disability and life to bring a sense of
acceptance, allowing participants to move beyond limiting
beliefs.
Main outcomes and results: The treatment group mean quality
of life (SF-36) improved by 15.40 (SD = 9.08) compared to
7 1.67 (SD = 16.65; p = 0.036) for controls. Improvements on
the cognitive-affective domain of the Beck Depression
Inventory II (BDI-II) were reported (p = 0.029), while changes
in the overall BDI-II (p = 0.059) and the Positive Symptom
Distress Inventory of the SCL-90R (p = 0.054) approached
statistical significance.
Conclusions: The intervention was simple, and improved
quality of life after other treatment avenues for these
participants were exhausted.
Introduction
At least 25% of individuals with traumatic brain inju-
ries (TBI) will have a residual impairment;
1
this propor-
tion climbs to as much as 67% for individuals with
major TBI.
2
Subtle residual deficits are evident even in
individuals where good recovery was believed to have
taken place.
3, 4
Residual deficits in executive functions,
memory and learning are well-documented.
5–7
At least
50% of individuals who experienced TBI reported
chronic pain, mostly in the form of headaches.
8
Among
a consecutive set of patients referred for neuropsycholo-
gical assessment, patients with TBI reported approxi-
mately twice as much pain and sleep problems than
general neurological patients.
9
Reduced independence
in activities of daily living and poor vocational
outcomes have also been reported.
7, 10 – 15
Brain injuries may lead to behavioural problems,
alcohol and drug use, and criminal behaviour.
16
A great-
er proportion of individuals with TBI is found in
psychiatric hospitals compared to general hospitals
and non- psychiatric medical clinics.
17
Individuals with
* Author for correspondence; Department of Psychology,
Lakehead University, 955 Oliver Road, Thunder Bay, Ontario,
P7B 5E1, Canada; e-mail: michel.bedard@lakeheadu.ca
DISABILITY AND REHABILITATION, 2003; VOL. 25, NO. 13, 722–731
Disability and Rehabilitation ISSN 0963–8288 print/ISSN 1464–5165 online
#
2003 Taylor & Francis Ltd
http://www.tandf.co.uk/journals
DOI: 10.1080/0963828031000090489
TBI may be at risk of depression.
18, 19
This risk may be
related to a sense of learned helplessness that develops
in some individuals.
20
Others may have post-traumatic
stress syndrome, and many feel lonely.
21
Compared to
people with spinal cord injuries, and non-disabled
controls, individuals with TBI reported more unmet
needs,
22
and reported changes in,
23
and often a loss of
‘self’.
24
The ultimate index of a successful rehabilitation is the
extent to which individuals with TBI resume their pre-
injury lifestyle and activities. This goal is often not
met, even when considering only individuals with mild
trauma. Two main explanations can be proposed. First,
recovery has reached a ceiling; individuals with TBI are
not expected to improve beyond the level achieved with
current interventions. Second, individuals with TBI have
a recovery potential that exceeds what current interven-
tions can offer. That is, individuals with TBI may benefit
from the added value of adjunct interventions to current
ones.
The first explanation, that recovery has reached a
plateau, is unsatisfactory. Recovery across individuals
is very variable, with some recovering fully and others
recovering poorly; we have few explanations for this
variability.
21
Further, the plateau explanation is defea-
tist; it offers little hope and detracts imaginative pursuits
of novel approaches. On the other hand, the possibility
that further progress can be achieved is theoret ically
plausible. Given that recovery varies across individuals,
and that the human brain is probably more plastic than
traditionally believed,
25
it is plausible that better
outcomes are possible for individuals whose recovery
lags behind others with sim ilar conditions.
Rehabilitation following TBI is typically classified
into one of three stages: acute, sub-acute, and post-
acute.
26
However, whereas physical, cognitive and beha-
vioural problems are usually addressed in TBI rehabili-
tation, psychological and emotional problems are rarely
targeted.
21
Yet, these problems may pose a greater threat
to successful rehabilitation than physical problems.
27
Many individuals with TBI lack awareness into their
situation in the initial stages of the post-injury period,
effectively reducing motivation.
21
Emotional function
often deteriorates as individuals with TBI become aware
of their limitations,
28
suggesting that improvement of
psychological and emotional function may translate into
better outcomes. Consistently, others showed associa-
tions between improvement in affect and self-awareness,
and goal attainment.
29
Our desire to test a novel intervention stems from the
realization that rehabilitation is a complex multi-factor-
ial process.
30
Holistic approaches integrating awareness,
self-concept, self-efficacy, and emotional issues are
crucial to rehabilitation and reintegration of individuals
with TBI.
31
Improvement in these domains and self-
esteem may allow the injured persons to find more
meaning in their lives.
21
Group therapy and peer support groups focusing on
these issues are increasing in popularity. Inherent in
these groups is a focus on healthy intera ctions with
others and reductions in isolation, the development of
self-help and social skills, and reassurance and optimism
about the future.
32, 33
The ultimate goal is for the indivi-
dual to attain his/her personal goals.
21
Although the
evidence regarding the efficacy of consumer-run peer
support groups is recent and preliminary, the feasibility,
and desirability of this type of intervention for a variety
of illnesses is documented.
32, 34
Further, group therapy
incorporating mindfulness meditation provided substan-
tial benefits to individuals experiencing chronic pain,
anxiety, dermatological conditions, and cancer.
35 – 41
Improvements were evident after follow-up s of up to 3
years.
37, 39, 40
The primary short-term objective of the study was to
determine the potential effectivene ss of a mindfulness-
based group-support intervention for individuals who
suffered mild/moderate TBI. We hypothesized the inter-
vention would improve quality of life, decrease depres-
sion symptoms, and increase the sense of control
experienced over their lives by individuals with TBI.
Methods
PARTICIPANTS, RECRUITMENT AND ELIGIBILITY
The study was conducted in a small urban centre
(population 125 000) located remotely from medical
academic centres. A convenience sample of 21 partici-
pants was recruited from four sources: (1) a commu-
nity-based rehabilitation programme, (2) referrals from
a local neuropsychologist, (3) the local brain injury asso-
ciation, and (4) through media coverage (newspaper
articles, television, posters, and hand-outs). The study
was approved by the local Ethics Committee.
Inclusion criteria included the ability to speak and
read English, aged 18 years or more but less than 65
years, and completion of traditional rehabilitation inter-
ventions. Another essential component of a successful
intervention was insight into one’s condition.
21
Unrealis-
tic self-appraisal is often found in individuals with TBI
21
and individuals with lack of insight were excluded.
Insight was determined by comparing participants’
scores on the Patient Competency Rating Scale
(PCRS)
42
with those obtained by their relatives or signif-
Mindfulness-based intervention in traumatic brain injuries
723
icant others (PCRS-R) as done by Prigatano and collea-
gues.
43
We also excluded participants if they were ch emi-
cally dependent or had major concurrent mental illness
(DSM-IV). Finally, participants were screened for suici-
dal ideation. The decision to include or exclude partici-
pants was based on a consensus determined by the study
clinical psychologists, in addition to scores on the Symp-
tom Checklist 90-Revised (SCL-90-R)
44
and on Beck’s
scale for suicidal ideation (BSS).
45
DESIGN
We used a pre-post design with control group. Parti-
cipants were initially assessed for eligibility. Those who
met criteria complet ed the remaining instruments an d
received the intervention. Following the intervention
all questionnaires were administered again. Drop-outs
were contacted to complete follow-up questionnaires
and were used as controls.
INTERVENTION
The intervention consisted of a weekly, 12-week
group interventi on, based on Kabat-Zinn’s mindful-
ness-based stress reducti on programme
41
and Kolb’s
experiential learning cycle.
46
To ensure the consistent
application of these principles a manual was developed
and followed throughout the intervention. The
approach emphasizes the importance of psychological
well-being as an essential component of health and qual-
ity of life through present moment awareness and accep-
tance. Using insight meditation, breathing exercises,
guided visualization, and group discussion as the
primary techniques, the facilitators encouraged partici-
pants to use self-exploration as a tool to harness the
transformative power present in themselves, empower-
ing participants to exert control over their situations.
Through the exploration of various themes the interven-
tion ultimately sought to encourage a new way of think-
ing about disability and how to approach life to bring a
sense of acceptance, allowing participants to move
beyond limiting beliefs.
DATA COLLECTION
Basic demogra phics collected included age, gender,
marital status, employment status, education, and medi-
cation use. Three types of outcome measures were
collected: (1) quality of life, (2) psychological processes,
and (3) function. To measur e quality of life we used the
Short Form Health Survey (SF-36),
47
a generic health-
related quality of life instrument. The SF-36 is divided
into ‘Mental Health’ and ‘Physical Health’ components.
Depression symptoms were measured with the Beck
Depression Inventory (BDI-II),
48
which can be divided
into a cognitive-affective factor and a somatic factor.
49
The BDI-II has high internal consistency (alpha = 0.92)
in this population.
50
Other psychological domains were
measured with the SCL-90-R, the Perceived Stress Scale
(PSS),
51
and the Multidimensional Health Locus of
Control Scale (MHLC).
52
Two composite scores for
the SCL-90-R are presented. The Global Severity Index
(GSI) is a single score that indicates the current number
and intensity of symptoms. The Positive Symptom
Distress Index (PSDI) represents the symptom intensity
only for those symptoms that were endorsed. The locus
of control scale is divided into three domains: internal,
powerful others, and chance. Function was assessed
with the home, social, and productive domains of the
Community Integration Questionnaire (CIQ).
53
The
scales have well-documented validity and reliability.
All data collection sessions were conducted at the
home of the participants. Baseline data were collected
using a two-stage process. Following informed consent,
participants completed the basic demographics, SF-36,
SCL-90-R, BSS, and PCRS. Caregivers completed the
PCRS-R. For participants who continued with the
study, a second meeting was arranged by the Research
Assistant to complete the BDI-II, the MHLC scale,
and the CIQ. Post-intervention data were collected
approximately 4 months after baseline data, also in
two sessions at the home of the participants. Feedback
about the content and format of intervention was
obtained by asking participants to complete a question-
naire with seven questions using a four-point Likert
scale. The information was summarize d to guide future
programme impro vement and is briefly presented in the
results.
STATISTICAL ANALYSES
To examine efficacy issues, pre-post changes for all
participants who completed the intervention were exam-
ined first with paired t -tests for the treatment group
alone. However, this approach did not control for
non-specific effects, hence, it was considered statistically
liberal (results are presented in tables but not discussed).
A more conservative approach used a two-way analyses
of variance (ANOVA) with drop-outs as controls for all
measures. The independen t variables were: (1) time (pre-
and post-interventi on), and (2) group (intervention or
control). Given that the hypotheses called for an
improvement among the intervention group but not
controls, the time by group interaction was the critical
M. Be
´
dard et al.
724
effect. Person r coefficients were used to assess correla-
tions. Given the low statist ical power of the analyses
effect sizes are presented.
Results
Of the 39 individuals referred by professionals and
self-referred, 21 of them agreed to be interviewed,
and 19 met inclusion criteria. Ten participants
completed the programme; three drop-outs agreed to
be interviewed as the control group. Demographics
are presented in table 1. With the exception of gender
most characteristics were similar between the treatment
and control participants. The mean number of medica-
tions taken by participants was 3.10 (SD = 2.85) for
the treatment group and 2.90 (SD = 3.00) for controls.
Anti-depressants were the most frequently used type of
medication; 50% of participants were taking anti-
depressants prior to and after the treatment sessions.
Pearson correlations between participants’ PCRS
scores and scores from significant others revealed a
moderate relationship (r(8) = 0.57). The respective
means for participants and significant others were
87.22 (SD = 15.12) and 86.67 (SD = 25.67). These data
confirmed that participants’ insight into their limita-
tions were corroborated by relatives.
The SF-36 Mental Health score of the intervention
group improved by 15.40 (SD = 9.08) at follow-up
compared to 7 1.67 (SD = 16.65) for the control group
(F(1,11) = 5.70, p = 0.036). The SF-36 Physical Health
was unchanged (F(1,11) = 1.75, p = 0.213, table 2).
The treatment by time interaction for the overall BDI-
II approached statistical significance (F(1,10) = 4.54,
p = 0.059; see table 3). Depression symptoms were
almost halved in the intervention group (mean reduc-
tion = 8.73, SD = 7.78). The effect size of 0.312 was in
the medium to large range. When we divided BDI-II
scores into cognitive-affective and somatic domains we
found a signifi cant improvement on the cognitive-affec-
tive domain (F(1,10) = 6.48, p = 0.029). The somatic
domain did not reveal changes (F(1,10) = 0.87,
p = 0.374).
It appeared possible that participants who reported
improvements in quality of life (Mental Health) were
the same who reported reductions in depression symp-
toms. To test this possibility we correlated changes in
SF-36 (Mental Health) with changes in BDI-II scores.
Data from all participant s for whom data on both vari-
ables at both time points were available (controls and
intervention) were used. We obtained a correlation coef-
ficient of 0.46 (p = 0.132). This relationship is depicted
in figure 1.
The Global Severity Index (GSI; SCL-90R) remained
unchanged after the intervention (F(1,11) = 1.30,
p = 0.278). However, the Positive Symptom Distress
Index (PSDI) approached statistical significan ce
(F(1,11) = 4.63, p = 0.054; see table 4), with a moderate
to large effect size. The PSS interaction was not statisti-
cally significant (F(1,10) = 0.34, p = 0.575; table 4).
Internal HLC approached statistical significance
(F(1,10) = 4.79, p = 0.053), but this effect appeared
explained by a shift towards external locus of control
among control participants rather than a shift towards
internal locus of control among those who completed
Table 1 Demographics
Variables
Treatment Group
(n = 10)
Control Group
(n =3)
Women (%) 7 (70%) 0 (0%)
Mean age (min, max) 43 (24, 55) 39 (26, 46)
Married/partner 3 (30%) 1 (33%)
Eduction 4 high school 6 (60%) 2 (67%)
Employed/student 3 (30%) 1 (33%)
Lives alone 2 (20%) 0 (0%)
Table 2 SF-36
Variable Treatment Control ANOVA F p
Effect
size t (df)* p*
SF-36 Mental Health ( + )
Pre 36.70 (10.44) 40.33 (20.82) Time 3.69 0.081 0.251
Post 52.10 (4.61) 38.67 (9.87) Group 0.77 0.399 0.065 7 5.36 (9) 0.001
Diff 15.40 (9.08) 7 1.67 (16.65) T 6 G 5.70 0.036 0.341
SF-36 Physical Health ( + )
Pre 42.10 (8.96) 53.00 (9.64) Time 0.54 0.476 0.047
Post 46.80 (11.14) 51.67 (16.56) Group 1.37 0.267 0.110 7 2.20 (9) 0.055
Diff 4.70 (6.73) 7 1.33 (7.77) T 6 G 1.75 0.213 0.137
Note: SF-36 = Short Form Health Survey; BSS = Beck Suicide Scale; (SD); ( + ) = improvement is based on higher test scores; * t-values (df) and
p-values are for the treatment group only
Mindfulness-based intervention in traumatic brain injuries
725
the programme. Both the powerful others and chance
locus of control domains were not significantly different
between completers and controls (F(1,10) = 1.16,
p = 0.307 and F(1,10) = 2.54, p = 0.142; see table 5).
We did not find changes on the CIQ following the inter-
vention (see table 6).
Nine participants completed and returned
programme evaluations. The mean response for all
seven questions was 3.34 on a 4-point Likert-type
scale suggesting positive evaluations of the interven-
tion. Participants agreed with statements such as ‘the
facilitators were effective’ and ‘the sessions were well
organized’.
Discussion
One of the primary objectives of this intervention was
to impr ove the quality of life of individuals who
sustained TBI. Consistently, the Mental Health
summary score of the SF-36 increased from 37 at base-
line to 52 after the intervention. This finding was both
statistically and clinically significant. The follow-up
mean is now equivalent to Canadian normative data
for men and women aged 35 – 44 years, which ranges
from 50.5 to 53.5.
54
The overall change recorded for
depression symptoms approached statistical signifi-
cance. The treatment group mean dropped by almost
50% wher eas the control group mean increased. The
effect size was strong, suggesting that a larger trial
would achieve statistical significance. The overall change
on the BDI-II was mostly the results of changes in the
cognitive domain scores (which achieved statistical
significance). These findings are consistent with the
conceptual focus of the intervention. While improve-
ments were noted on psychological/emotional domains,
we did not find changes on the Physical Health summary
of the SF-36 or on the somatic domain of the BDI-II.
Results on the SCL-90-R did not reveal an improve-
ment but must be examined in light of the inclusion/
exclusion criteria; potential participants who ha d severe
symptoms were excluded from the study, possibly creat-
ing a floor effect. Nevertheless, improvements on the
Positive Symptom Distress Inventory sub -scale
approached statistical significance with a good effect
size. These results are consistent with those observed
with the SF-36 and the BDI-II, and results reported
by others.
35
However, using the PSS we found reduc-
tions in perceived stress equivalent in both the treatment
and control groups. Therefore, the impact of the inter-
Table 3 Beck Depression Inventory-II
Variable Treatment Control ANOVA F p
Effect
Size t (df)* p*
BDI-II ( 7 )
Pre 18.43 (12.18) 12.50 (7.78) Time 0.83 0.384 0.077
Post 9.70 (10.64) 16.00 (9.90) Group 0.00 0.982 0.000 3.55 (9) 0.006
Diff 8.73 (7.78) 7 3.50 (2.12) T 6 G 4.54 0.059 0.312
Cognitive-Affective ( 7 )
Pre 9.66 (7.54) 3.00 (2.83) Time 0.15 0.705 0.015
Post 4.90 (5.80) 6.50 (4.95) Group 0.28 0.607 0.027 3.45 (9) 0.007
Diff 4.76 (4.36) 7 3.50 (2.12) T 6 G 6.48 0.029 0.393
Somatic ( 7 )
Pre 5.80 (3.58) 6.00 (2.83) Time 1.95 0.193 0.163
Post 3.30 (3.77) 5.50 (3.54) Group 0.21 0.655 0.021 2.71 (9) 0.024
Diff 2.50 (2.22) 0.50 (0.71) T 6 G 0.87 0.374 0.080
Note: BDI-II = Beck Depression Inventory 2
nd
edition; values are means (SD); ( 7 ) = improvement is based on lower test scores; * t-values (df) and
p-values are for the treatment group only
Figure 1 Depicted is the relationship between changes in
depression symptoms (BDI-II change; negative change in-
dicates improvement) and changes in quality of life (SF-36
change, Mental Health; positive change indicates improve-
ment). The closed squares represent actual data points, the line
is the best fitting regression line.
M. Be
´
dard et al.
726
Table 5 Health locus of control scales
Variable Treatment Control ANOVA F p
Effect
Size t (df)* p*
IHLC ( + )
Pre 24.10 (6.49) 22.50 (4.95) Time 3.81 0.079 0.276
Post 24.50 (5.48) 15.50 (0.71) Group 1.62 0.232 0.139 7 0.29 (9) 0.779
Diff 0.40 (4.38) 7 7.00 (4.24) T 6 G 4.79 0.053 0.324
PHLC ( 7 )
Pre 19.00 (4.83) 19.50 (4.95) Time 1.33 0.277 0.117
Post 19.10 (6.03) 22.50 (6.36) Group 0.23 0.639 0.023 7 0.09 (9) 0.930
Diff 7 0.10 (3.63) 3.00 (1.41) T 6 G 1.16 0.307 0.104
CHLC ( 7 )
Pre 19.00 (3.83) 21.00 (0.00) Time 0.02 0.888 0.002
Post 22.00 (4.29) 18.50 (3.54) Group 0.09 0.772 0.009 7 2.09 (9) 0.067
Diff 7 3.00 (4.54) 2.50 (3.54) T 6 G 2.54 0.142 0.203
Note: IHLC = Internal Health Locus of Control; PHLC = Powerful Others Health Locus of Control; CHLC = Chance Health Locus of Control;
values are means (SD); ( + ) = improvement is based on higher test scores; ( 7 ) = improvement is based on lower test scores; * t-values (df) and p-
values are for the treatment group only
Table 4 Global Severity Index (GSI) and the Positive Symptom Distress Inventory (PSDI; SCL-90-R) and Perceived Stress Scale (PSS)
Variable Treatment Control ANOVA F p Effect Size t (df)* p*
GSI ( 7 )
Pre 1.45 (0.86) 1.16 (0.96) Time 7.59 0.019 0.408
Post 0.89 (0.66) 0.92 (0.63) Group 0.07 0.798 0.006 3.88 (9) 0.004
Diff 0.55 (0.46) 0.23 (0.34) T 6 G 1.30 0.278 0.106
PSDI ( 7 )
Pre 2.23 (0.67) 1.93 (0.90) Time 5.92 0.033 0.350
Post 1.63 (0.53) 1.89 (0.94) Group 0.00 0.955 0.000 4.33 (9) 0.002
Diff 0.60 (0.44) 0.04 (0.07) T 6 G 4.63 0.054 0.296
PSS ( 7 )
Pre 30.98 (8.50) 32.00 (12.73) Time 8.01 0.018 0.445
Post 22.40 (7.12) 19.00 (18.38) Group 0.04 0.842 0.004 2.66 (9) 0.026
zDiff 8.58 (10.20) 13.00 (5.65) T 6 G 0.34 0.575 0.033
Note: GSI = Global Severity Index; PSDI = Positive Symptom Distress Inventory; PSS = Perceived Stress Scale; values are means (SD);
( 7 ) = improvement is based on lower test scores; * t-values (df) and p-values are for the treatment group only
Table 6 Community integration questionnaire
Variable Treatment Control ANOVA F p
Effect
Size t (df)* p*
CIQ Home ( + )
Pre 7.00 (2.98) 4.50 (2.12) Time 1.89 0.199 0.159
Post 7.30 (2.31) 6.00 (5.66) Group 0.80 0.392 0.074 7 0.71 (9) 0.500
Diff 0.30 (1.34) 1.50 (3.54) T 6 G 0.84 0.381 0.077
CIQ Social ( + )
Pre 5.60 (2.22) 8.00 (2.83) Time 2.59 0.139 0.206
Post 6.45 (2.52) 9.50 (0.71) Group 2.68 0.133 0.211 7 1.48 (9) 0.180
Diff 0.85 (1.86) 1.50 (2.12) T 6 G 0.20 0.666 0.019
CIQ Productive ( + )
Pre 1.56 (1.24) 1.00 (1.41) Time 2.62 0.140 0.225
Post 1.89 (0.93) 2.00 (0.00) Group 0.09 0.771 0.010 7 1.00 (9) 0.350
Diff 0.33 (1.00) 1.00 (1.41) T 6 G 0.66 0.439 0.068
Note: CIQ = Community Integration Scale; values are means (SD); ( + ) = improvement is based on higher test scores; * t-values (df) and p-values
are for the treatment group only
Mindfulness-based intervention in traumatic brain injuries
727
vention on the stress experienced by participants
remains difficult to interpret.
We noted a deterioration of internal locus of control
among control participants but no change among
completers. However, it is impossible to determine if this
effect represents a spontaneous deterioration for
controls, a statistical aberration (given the sample size),
or a genuine protective effect of the intervention. This
remains to be elucidated. This finding did not support
our hypothesized gain in internal locus of control.
Further work is necessary to unveil the mechanism
underlying the quality of life improvement reported
here. A possible explanation is a relationship between
quality of life and depression symptoms.
55, 56
Our corre-
lation between changes in quality of life and changes in
depression symptoms was in this direction but did not
achieve statistical significance. Nonetheless, 20% of
the variability in quality of life change was explained
by the variability in depression score ch ange, and the
relationship would have achieved statistical significance
with seven more participants.
Participants’ functioning, as assessed by the CIQ,
revealed no sign of improvement. Others have also
reported little changes in function (using the CIQ)
beyond immediate post-acute gains.
57
Furthermore,
changes on these outcomes may take place months from
programme cessation, and may require the sustained
improvement observed on quality of life and depression
symptoms.
There are several limitations to the present study that
must be addressed in future research. Foremost is the
sample size. The validity of the statistical analyses may
be questioned, and the statistical power was very low,
especially in the context of two-way interactions.
However, we deliberately c hose a conservative analytical
plan to reduce the risk of Type I errors. Nonetheless, the
findings were consistent with the conceptual focus of the
intervention and effect sizes were strong. Another limita-
tion related to the sample size is our inability to consider
the impact of medication use or number of years post-
injury on our measures. The current sample was
approximately 3 – 10 years post injury, which leaves a
considerable time between conventional approaches to
recovery and this intervention.
The small sample size can be explained by recruitment
and retention difficulties. These difficulties prevent us
from generalizing the present findings to the general
population of individuals who suffered TBI. Only 50%
of all potential participants started the programme and
fewer completed it. We experienced difficulties recruiting
young men despite the prevalence of TBI in this group.
Judging from those who completed the study middle-
aged women may have had stronger motivation to enrol
and complete the programme. The majority of men and
younger participants either did not enrol or dropped out
of the programme. Regarding retention, transportation
was a concern for many participants especially in the
winter months. Several participants had mobility
problems that made attendance to the weekly sessions
a challenge. Many participants lived out of reach from
the public transportation system and were dependent
on others for transportation.
Despite these shortcomings we are encouraged that
the intervention improved quality of life and possibly
reduced depression in individuals who had exhausted
all previous therapeutic avenues. These findings are
especially encouraging for women. Usi ng a meta-analy-
sis of eight studies Farace and Alves
58
concluded that
women have worse outcomes than men after a TBI on
17 out of 20 outcome measures. One possible explana-
tion for this finding is that men and women have differ-
ent needs and current interventions target men’s needs
more successfully. If such is the case, our intervention
may help reduce this inequality. Further research should
investigate gender differences in more details, including
the reasons underlyi ng young men’s reluctance to parti-
cipate in this study.
Future research should also include follow-ups. The
positive impact of the intervention on quality of life
may not be maintained in the long-term. On the other
hand, it is possible that improvements in other
domains (e.g., return to work) will emerge at a later
time. Larger trials would also improve statistical
power and provide more precise estimates of the inter-
vention effectiveness.
Finally, future work should include caregivers as
intervention targets. Loved ones, relatives, and friends
are often affected, albeit indirectly, by TBI.
59 – 64
Care-
givers of individuals with TBI are at higher risk of
experiencing psychological and emotional problem s
than controls.
65 – 68
Ultimately, caregiver depression,
coping, and social supports may have a larger impact
on family functioning than injury severity.
69
There is reason to believe that multidisciplinary inter-
ventions that can impr ove the situation of individuals
with TBI will positivel y affect caregivers and relatives.
70
The intervention we used may also have had a beneficial
effect on caregi vers. However, it would be misleading to
assume that addressing the needs of individuals with
TBI is sufficient to fully support caregivers. Caregivers
may have unmet needs of their own, such as the need
for emotional support,
71
that need to be addressed sepa-
rately. Ultimately, interventions focusing on the whole
family are required.
72
M. Be
´
dard et al.
728
Overall, the objectives of this pilot study were to
determine the potential effectiveness of a holistic mind-
fulness-based interventi on as an adjunct to conven-
tional medical and rehabilitation interventions. Data
on the SF-36 (Mental Health) are very encouraging
and warrant further research. Furthermore, while the
availability of conventional rehabilitation programmes
is sometimes limited because of geographical or finan-
cial reasons,
73
and this applies to the remote region
where this study was condu cted, we are encouraged
that a simple interventi on, delivered by individuals
who do not have advanced medical training, may have
the potential to improve quality of life. Future research
is required to determine if this intervention could be
the building block for an adjunct rehabilitation
programme.
Acknowledgements
We extend our sincerest thanks to Ms. Alice Bellavance and Dr.
M.A. Mountain for their invaluable help in the recruitment process
and their participation in the Advisory Committee. We also thank
other members of the Advisory Committee: Ms. Michele Meehan, Mr.
David Shannon, Ms. Erin May, Ms. Nancy Debruyne, and Ms. Janice
Cerra for their co-operation towards the successful completion of this
study. This study was supported by a research grant from the Ontario
Neurotrauma Foundation. The results and conclusions are those of the
authors.
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