The effect of cognitive rehabilitation therapy and mindfulness based cognitive therapy on cognitive functioning in multiple sclerosis.

Patients with multiple sclerosis (MS) often suffer from cognitive impairments,
which have a huge impact on quality of life (QoL) and psychosocial functioning.
Prevalence rates between 30 and 70% have been reported. Objective cognitive
decline as determined by neuropsychological testing corresponds with grey
matter pathology in MS. Altered functional connectivity (FC) between brain
regions as assessed by functional magnetic resonance imaging (fMRI) and
magnetoencephalography (MEG) might also underlie these cognitive problems. So
far, studies indicate that current disease modifying therapies do not
significantly affect subjective and objective cognitive impairments in MS. This
highlights the need to create evidence based treatment options and to gain
additional knowledge about the aetiology of cognitive complaints among patients
with MS.

The main aim of the current study is to investigate whether two promising
therapies, namely cognitive rehabilitation therapy (CRT) and mindfulness based
cognitive therapy (MBCT), may improve cognitive functioning of patients with
MS. Additionally, MEG and modern network theory will be used to gain additional
knowledge about the aetiology of subjective and objective cognitive dysfunction
as determined by functional network changes at baseline, and to unravel if
cognitive improvements (subjective or objective) after both interventions are
associated with functional brain network changes.

In a dual-centre, single-blinded, parallel group randomized controlled trial
(RCT), 120 patients with MS will be assigned to either one of the therapies or
an enhanced treatment as usual (ETAU) condition. Both CRT and MBCT consist of a
structured 9-week program. Assessments will be performed at baseline,
post-intervention, and 6 months after the end of the intervention.

CRT consists of a combination of cognitive training, psycho-education,
compensatory strategy training, and homework assignments aimed at applying the
learned strategies in daily life situation. CRT focuses on the domains of speed
of information processing, memory, executive functioning, and mental fatigue.
MBCT is an intervention in which aspects of mindfulness meditation are combined
with aspects of cognitive behavioral therapy. MBCT focuses on increasing
awareness of the present moment. ETAU consists of one appointment with an MS
specialist nurse and is focused on psycho-education.

The burden in the study consists of participating in three repeated
measurements, therapy sessions, and homework assignments. For all participants,
the measurements consist of an objective neuropsychological assessment
(approximately 90 minutes) and MEG scan (approximately 45 minutes) at the VU
University Medical Center, and questionnaires which can be filled out at home
(approximately 60 to 90 minutes). Participants assigned to the CRT group will
have nine 2,5-hour group sessions and participants assigned to the MBCT group
will have eight 2,5-hour group sessions and one silent day. For both the CRT
and MBCT group, participants are required to participate in home practice
sessions of 45 minutes for 6 days per week. Participants in the ETAU group will
attend one appointment with an MS specialist nurse. The interventions take
place at one of the participating centres (VU medical centre or Klimmendaal
Rehabilitationspecialists). Anticipated benefits of CRT and MBCT are
improvements in subjective and objective cognitive functioning and psychosocial
functioning.