Multiple Sclerosis Clinical Trial
Official title:
A Randomized Controlled Trial Testing the Additive Benefits of CBT and Exercise For Psychological Stress and Cognitive Dysfunction in MS
Verified date | October 2016 |
Source | Sunnybrook Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 173 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of relapse-remitting MS according to the McDonald criteria - General Health Questionnaire short form (GHQ-12) score of =2 - Extended Disability Status Scale (EDSS) score of =5 - Physical Activity Readiness Questionnaire (PAR-Q) score of =1 Exclusion Criteria: - Any past history of traumatic brain injury, psychotic mental illness, developmental delay, substance abuse (excluding cannabis) and systemic illness - Current (last 6 months) participation in an exercise regimen of moderate-strenuous intensity, greater than 2 days a week - Incapable of providing informed consent |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Multiple Sclerosis Society of Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks | The GHQ-28 is a 28-item self-report used to psychological stress. The GHQ focuses on two main classes of phenomena: 1) inability to carry out one's normal healthy functions; and 2) emergence of new phenomena that are distressing. | Baseline and 12 weeks | No |
Secondary | Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks | The Minimal Assessment of Cognitive Function in MS (MACFIMS)is a 90 minute cognitive battery comprised of seven tests covering five cognitive domains commonly impaired in MS (processing speed/working memory; learning and memory; executive function; visuo-spatial processing; word retrieval). | Baseline and 12 Weeks | No |
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