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Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Multiple Sclerosis Society of Canada
Information provided by (Responsible Party):
Dr. Neil Rector, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01763983
First received: January 7, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Cognitive Deficits
Stress, Psychological
Behavioral: Cognitive Behavioural Therapy
Behavioral: Aerobic Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Testing the Additive Benefits of CBT and Exercise For Psychological Stress and Cognitive Dysfunction in MS

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 173
Study Start Date: January 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aerobic Exercise
12-week structured and monitored aerobic exercise program
Behavioral: Aerobic Exercise
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.
Experimental: Cognitive Behavioural Therapy and Aerobic Exercise
Combined 12-week individual CBT and Exercise Program
Behavioral: Cognitive Behavioural Therapy

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.

Other Name: CBT
Behavioral: Aerobic Exercise
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.
No Intervention: Waitlist Condition
12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01763983

Contacts
Contact: Bethany I Lerman, BA Hons. 416-480-6100 ext 7958 bethany.lerman@sunnybrook.ca
Contact: Neil A Rector, PhD., C.Psych. 416-480-6100 ext 2233 neil.rector@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Bethany Lerman    416-480-6100 ext 7958    bethany.lerman@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Multiple Sclerosis Society of Canada
  More Information

No publications provided

Responsible Party: Dr. Neil Rector, Psychologist, Research Scientist and Director of the Mood and Anxiety Treatment and Research Program, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01763983     History of Changes
Other Study ID Numbers: EG1290
Study First Received: January 7, 2013
Last Updated: April 28, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Multiple Sclerosis
Stress, Psychological
Psychological Stress
Emotional Stress
Cognitive Deficits
Cognitive Dysfunction

Additional relevant MeSH terms:
Stress, Psychological
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 23, 2014