Mindfulness Based Cognitive Therapy for subjective fatigue in patients with multiple sclerosis: a prospective cohort study on effectiveness and feasibility.

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the
central nervous system and the most common neurological disorder affecting
young adults.Up to 90% of patients with MS complain of fatigue. This fatigue
can severely affect the ability to perform activities of daily life and is a
major reason for unemployment. Therefore, fatigue in MS patients is related to
disability and poor quality of life. Although fatigue is one of the most common
and disabling symptoms in MS patients, its pathogenesis is still poorly
understood and evidence-based treatment options are limited. Depression might
be an important perpetuating factor in MS-related fatigue and depression and
fatigue contribute independently to the patient*s quality of life. Anxiety,
either with or without depression, occurs in 25% of MS patients. Anxiety
co-morbid with depression, is associated with increased thoughts of self harm,
more somatic complaints and greater social dysfunction, and thereby adding to
the morbidity associated with MS.
Although there is some evidence for underlying pathophysiological mechanisms in
MS-related fatigue, including inflammation, demyelinisation, axonal loss and
neuroendocrine dysregulation, these variables appear to explain only a
relatively small part of the variance of both MS-related fatigue and its
disability. There is growing evidence that cognitive behavioural factors such
as catastrophising thoughts about MS and fatigue, influence MS related fatigue
and its disability. Cognitive behavioural therapy (CBT) has been proven to be
effective for reducing fatigue in several somatic populations. Van Kessel et
al. (2008) investigated the effect of CBT for fatigue in MS-patients, where it
proved to be clinically effective. More specifically, the change in the
negative representation of fatigue plays a crucial role in the reduction of
fatigue in MS after CBT.
More recent, there has arisen a new generation of CBT, including mindfulness
components. Kabat-Zinn, the founder of mindfulness training, defines
mindfulness as *paying attention, on purpose, in the present moment, and
nonjudgmentally*. One of the concepts of mindfulness is the assumption that
people often function in an automatic pilot mode, which makes them unaware of
their potentially maladaptive coping strategies. The aim of mindfulness
training is to learn skills that enhance the ability to raise awareness of
present experiences. Being aware of their present experience allows people to
choose for more helpful coping behavior.
Kabat-Zinn*s Mindfulness-Based Stress Reduction (MBSR) training has been proven
effective in several somatic populations for reducing both physical and
emotional symptoms. Until now, only one randomized clinical trial on
mindfulness approaches has been conducted in MS patients, in which MBSR was
compared with care as usual. After six months, the MBSR intervention group
reported significantly less symptoms of fatigue and depression compared to the
control group. Furthermore, the quality of life of MS patients was
significantly improved after the intervention in contrast to the control group.
The effectiveness of MBSR might be improved by integrating elements of
cognitive behavioural therapy. The latter has been done by the introduction of
mindfulness-based cognitive therapy. MBCT is a group intervention in which
participants are trained to become aware of their emotions, sensations and
(negative) automatic thoughts. In contrast to CBT, MBCT does not emphasize
changing the content or specific meaning of negative automatic thoughts.
Empirical evidence for the effectiveness MBCT has been found in fatigued cancer
survivors and chronic pain patients. Little is known about MBCT effect in
populations with neurological disorders. The results of a qualitative study in
Parkinson's Disease (PD), that is like MS, a neurodegenerative disease in which
fatigue, depression and cognitive disorders, are frequent and disabling
symptoms, are promising; The MBCT helped PD-patients in coping with their
disease.
Until now, there are no studies we know of, on the effectiveness of MBCT in MS
and therefore, the proposed study can be considered as a possible addition to
the treatments available.

The purpose of the present study is the evaluation of the effectiveness of MBCT
in MS patients. Based on previous research we hypothesize that after the MBCT
intervention period, MS patients will have significantly less symptoms of
fatigue than after the waiting list period. Furthermore, we hypothesize that
MBCT has a positive effect on symptoms of anxiety and depression, sleep
problems, quality of life and catastrophizing thoughts about fatigue. Next, we
will explore the impact of MBCT on the level of mindfulness, cognitive
complaints and coping style. Finally, we will evaluate whether patients with
cognitive disorders will benefit as much of the MBCT as patients without
cognitive disorders.

The design of the current study is a prospective cohort study with a ten weeks
waiting list control period, a ten weeks period of treatment and a three-month
follow up.

The MBCT protocol we will use is described by Segal et al. (2004) and is a
group intervention. We made some adaptations for fatigue, because Segal*s
protocol was developed for patients with recurrent depressive episodes. The
adaptations we use will be acquired by Van der Lee and Garssen (2010), who used
this protocol for fatigued cancer survivors. Where van der Lee and Garssen use
information about the relation between cancer and fatigue in the protocol, we
will use information about the relation between MS and fatigue. Also the case
described in the reader about a patient with cancer, will be changed to a case
of a patient with MS. The treatment involves eight weekly meetings of 2,5 hours
training during a period of 10 weeks. Meditation exercises, yoga exercises and
psycho-education are part of the MBCT training. Patients will be given a
workbook with instructions to read at home after each session and compact disks
with exercises to do at home. Patients are asked to do the homework and
exercises on a daily basis for about 45 minutes 6 days a week. Patients will
keep track of their home progress by making entries in a diary.

The treatment involves eight weekly meetings of 2,5 hours training during a
period of 10 weeks.
Completing all the outcome questionnaires will take about 20-30 minutes. All
outcome measurements will be performed at inclusion, at the start of the
treatment 10 weeks later, at the end of the treatment and at follow up 3 months
after finishing the program.
The primary outcome measure will be administered twice during the waiting list
period and once during the treatment period. Completing the primary outcome
measure will take about 3-5 minutes.
Neuropsychological tests (see p.7 of the protocol) will be adminsitered once at
inclusion, and will take about 20-30 minutes.
Patients are asked to do the homework and exercises on a daily basis for about
45 minutes 6 days a weekduring the treatment period. They will keep track of
their home progress by making entries in a diary.
Exercising on a daily basis is necessary to accomplish a therapeutic effect.
There are no risks associated with the treatment. In fact, the training is an
existing treatment which, by means of this study, will be applied to a new
patient group.