Multiple Sclerosis Clinical Trial
Official title:
Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis: a Randomized Clinical Trial
The study design was a parallel-group randomized trial with equal randomization. Recruitment
and enrollment were conducted between January 2013 and March 2013. At base-line, cognitive
data was collected. Afterwards, the participants were randomly allocated to either the
REHACOP group or the Control group. During 3 months the intervention with REHACOP program
took place and at follow-up patients were again re-evaluated to evaluate the change in
cognitive measure. Post-treatment assessment (finished by July 2013) was performed within the
first week after completing the intervention. Optional enrollment in pre-post neuroimaging
will also allow us to look at changes in the brain.
Objective: To examine the efficacy of an integrative cognitive training program (REHACOP) to
improve cognition of patients with Multiple Sclerosis (MS).
Assessment protocol:
Patients underwent an extensive neuropsychological battery including test of attention,
working memory, processing speed, verbal memory (learning and recall), verbal fluency and
executive functioning. Sustained attention was measured using the Brief Test of Attention.
For working memory, the Backward Digits subtest of the Weschler Adult Intelligence Scale III
was used. Processing speed was assessed through the Symbol Digit Modalities Test, the three
and six letter version of the Salthouse Perceptual Comparison Test and the Trail Making Test
A. Verbal memory was determined based on the Hopkins Verbal Learning Test , learning and
long-term recall performance. For verbal fluency, the Category (animals and supermarket) and
Letter (P) Word Fluency Test from the Calibrated Ideational Fluency Assessment were utilized
. Executive functioning was calculated by the word-color and interference scores of the
Stroop Word-Color Test.
Additionally, several test and scales were administered. The Expanded Disability Status Scale
was used for rating the degree of neurologic impairment. Premorbid IQ was tested by The
Accentuation Reading Test. Cognitive reserve was estimated with the Cognitive Reserve
Questionnaire. The 15-item Geriatric Depression Scale was included to assess patients´
depressive symptoms. The Fatigue Severity Scale and the mental fatigue Visual Analogue Scale
were included to evaluate physical and mental fatigue, respectively.
Description of the intervention:
REHACOP is a structured program using paper-pencil tasks and it is based on the principles of
restoration, compensation and optimization with a gradually increasing level of cognitive
effort and demand. REHACOP trains different cognitive domains, such as attention, memory,
processing speed, language, executive functioning and social cognition. Additionally, the
program includes one unit related to functional outcome: activities of daily living. REHACOP
includes up to 300 different tasks hierarchically organized into at least three levels of
difficulty and subtypes of abilities. Several tasks are timed, so processing speed is trained
throughout various modules. Once a basic cognitive strategy has been trained and well
acquired, the therapist transitions the program to the next level. The program format allows
for either individual or group sessions (between 5 and 8 patients per group), although for
the purpose of this study, group sessions were chosen. In this study, two psychologists
conducted the REHACOP group attending 60-minute-long sessions 3 days per week at Multiple
Sclerosis Association of Biscay (ADEMBI) (four groups). Specifically, REHACOP group
remediation with MS patients consisted of: Attention unit (4 weeks) training sustained,
selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and
verbal learning, recall and recognizing memory, as well as in working memory; Language unit
(3 weeks) including verbal fluency, grammar, syntax, vocabulary, verbal comprehension,
abstract language; Executive functions unit (2 weeks) training development, planning and
attainment of objectives; and Social cognition unit (1 week) exercising theory of mind,
social reasoning and moral dilemmas.
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