Multiple SclerosisNCT01763983
Effects of Cognitive Behavioural Therapy and Exercise on Stress and Cognitive Deficits in Multiple Sclerosis
A study testing Cognitive Behavioural Therapy and Aerobic Exercise in people with Multiple Sclerosis and Cognitive Deficits, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Cognitive Deficits, Stress, Psychological
- What is being tested?
- Cognitive Behavioural Therapy and Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Testing the Additive Benefits of CBT and Exercise For Psychological Stress and Cognitive Dysfunction in MS
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.
Read more
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.
- Being tested
- Cognitive Behavioural Therapy, Aerobic Exercise
- Keywords
- Multiple Sclerosis, Stress, Psychological, Psychological Stress, Emotional Stress, Cognitive Deficits, Cognitive Dysfunction
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders, Stress, Psychological, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Also called CBT
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | 12-week structured and monitored aerobic exercise program Receives: Behavioral: Aerobic Exercise |
| CBT and Aerobic Exercise | Experimental | Combined 12-week individual Cognitive Behavioural Therapy and Exercise Program Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 12 weeks
Secondary outcomes (1)
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).
Measured: Baseline and 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Principal investigator, Dr. Neil Rector, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763983
- Sponsor's protocol ID
- EG1290
- Status last verified
- Oct 2016
- First submitted
- 7 Jan 2013
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Testing the Additive Benefits of CBT and Exercise For Psychological Stress and Cognitive Dysfunction in MS
- ClinicalTrials.gov ID
- NCT01763983
- Acronym / sponsor ID
- EG1290
- Keywords
- Multiple Sclerosis, Stress, Psychological, Psychological Stress, Emotional Stress, Cognitive Deficits, Cognitive Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- Jan 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: Aerobic Exercise12-week structured and monitored aerobic exercise program |
| CBT and Aerobic Exercise | Experimental | Behavioral: Cognitive Behavioural Therapy, Behavioral: Aerobic ExerciseCombined 12-week individual Cognitive Behavioural Therapy and Exercise Program |
| Waitlist Condition | No intervention | –12-week waitlist control condition, after which participants will have the chance to receive CBT group treatment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyAlso: CBTCBT 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. | Behavioural | CBT and Aerobic Exercise |
| Aerobic ExerciseAerobic 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. | Behavioural | Aerobic Exercise, CBT and Aerobic Exercise |
Primary outcome
Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks
Time frame: Baseline and 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.
1 secondary outcome
Change from Baseline in the Minimal Assessment of Cognitive Function in MS at 12 Weeks
Time frame: Baseline and 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy and Aerobic Exercise in people with Multiple Sclerosis and Cognitive Deficits, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in General Health Questionnaire (GHQ-28) at 12 Weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.