Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis
Condition: Multiple Sclerosis; Cognitive Deficits; Stress, Psychological
MeSH terms: Multiple Sclerosis; Sclerosis; Cognitive Dysfunction; Stress, Psychological; Cognition Disorders
Study type: Interventional

Summary: 
      High levels of psychological stress have been reported by 90% of patients with MS
      experiencing disease exacerbation, and approximately 39% of those with more stable disease
      course. These stress levels are comparable to patients with a clinical diagnosis of major
      depression. Cognitive dysfunction affects approximately 40% of community surveyed MS
      patients, and stress may exacerbate the cognitive burden. Studies have shown that Cognitive
      Behavior Therapy (CBT) is effective in treating psychological stress. Studies have also shown
      that exercise is beneficial to mood and cognitive function. Therefore the proposed study will
      test the comparative benefits of combining CBT and Exercise as an intervention for stress and
      cognitive dysfunction in MS subjects. The 2 active treatment conditions will be compared with
      a waitlist control condition.

      There are 4 broad aims to this study: 1) to compare the relative efficacy of CBT, Exercise,
      and CBT-Exercise for stress in MS, 2) to examine the extent to which neuropsychological
      features of stress and MS, especially working memory and executive functioning, improve
      following treatments, 3) to determine the extent to which neuropsychological factors are
      associated with successful treatment response and improved quality of life, and 4) to
      determine if combined CBT-Exercise confers greater benefits on measures of stress and
      neuropsychological functioning compared with Exercise alone.

      The study hypotheses are: 1) All active treatment conditions will lead to significantly
      greater improvement on measures of stress at post-treatment and follow-up compared to
      waitlist controls, 2) Combined CBT-Exercise will lead to comparatively greater symptom
      reduction compared to all other conditions at post-treatment and follow-up assessments on
      measures of stress, 3) All active treatment conditions will lead to significant improvement
      in neuropsychological functioning (particularly measures of working memory and executive
      functioning) at post-treatment compared to controls, and 4) Combined CBT-Exercise will lead
      to greater improvement in neuropsychological functioning compared to all other conditions at
      post-treatment.

      The study design allows for examination of the potential additive benefits of CBT and
      Exercise to usual therapy for patients, and its feasibility as a viable treatment model for
      MS outpatient clinics and community-based intervention programs. This study will shed light
      on the treatment of sub-threshold symptoms that are strikingly common in MS population, but
      often overlooked in favour of more concrete diagnoses (e.g. major depression disorder). This
      proposed study will also be the first to determine whether evidence-based non-medical
      treatments for stress and mood disturbances in MS reduce underlying cognitive substrates
      associated with the illness and known to be exacerbated by stress.
    


Intervention name(s): Cognitive Behavioural Therapy; Aerobic Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): CBT will be delivered individually, 1 hour per week, for 12 consecutive weeks. CBT for stress in MS is a structured, short-term, present-oriented therapy with an emphasis on problem-solving and the modification of dysfunctional thinking and behaving. Cognitive strategies include the use of dysfunctional thought records for recording and challenging negative automatic thoughts and the use of behavioural strategies to increase involvement and commitment to personal goals.
Group therapy following a similar protocol (2 hrs/week) will be offered to those in the waitlist condition after completing the study.; Aerobic exercise will occur three times per week at participating gyms. Duration of the exercise periods will be 15-30 minutes for the first 4 weeks (training stage) and 30-45 minutes for the remaining 8 weeks (improvement stage). The exercise regimen will progress from light-moderate exercise (40-60% intensity) to moderate-high exercise (60-80% intensity), following the same course as the increase in duration.
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Stress, Psychological; Psychological Stress; Emotional Stress; Cognitive Deficits; Cognitive Dysfunction