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

NCT01763983 | Completed DMC

• 1 other identifier: EG1290
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis; Cognitive Deficits; Stress, Psychological

Keywords

Multiple Sclerosis; Stress, Psychological; Psychological Stress; Emotional Stress; Cognitive Deficits; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks

  Baseline and 12 Weeks

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL

12-week structured and monitored aerobic exercise program

Behavioral: Aerobic Exercise

CBT and Aerobic Exercise

EXPERIMENTAL

Combined 12-week individual Cognitive Behavioural Therapy and Exercise Program

Behavioral: Cognitive Behavioural Therapy; Behavioral: Aerobic Exercise

Waitlist Condition

NO INTERVENTION

12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

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.

Also known as: CBT

CBT and Aerobic Exercise

Aerobic Exercise BEHAVIORAL

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.

Aerobic Exercise; CBT and Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis; Cognition Disorders; Stress, Psychological; Cognitive Dysfunction

Interventions

Cognitive Behavioral Therapy; Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, Research Scientist and Director of the Mood and Anxiety Treatment and Research Program

Study Record Dates

• First Submitted: January 7, 2013
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10

Locations

CA (1)