Integrative Group-based Cognitive Rehabilitation Efficacy in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      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).
    

Detailed description: 
      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.
    

Intervention name(s): cognitive remediation program: REHACOP
Intervention type(s): Other
Intervention description(s): Specifically, REHACOP group remediation with MS patients consisted of: four weeks training attention (sustained, selective, alternating and divided attention); three weeks focused on learning and memory (the stimulation of verbal and visual memory was combined with learning and compensatory strategies, working memory was also trained); three weeks exercising executive functioning (development, planning and attainment of objectives); three weeks focused on language (verbal fluency, syntax, grammar, vocabulary and comprehension); and one week training social cognition (social reasoning, theory of mind and moral dilemmas).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis, cognitive rehabilitation, REHACOP