Cognitive and Emotion Regulation Training in MS



Status:Recruiting
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:30 - 59
Updated:4/21/2016
Start Date:October 2015
End Date:August 2017
Contact:Brittney L Schirda, MA
Email:schirda.1@buckeyemail.osu.edu
Phone:614-292-9568

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Cognitive and Emotion Regulation Training in Multiple Sclerosis

The investigators propose to conduct a randomized feasibility study of mindfulness
meditation training (MMT) relative to an active cognitive training control group and
waitlist control group in improving emotional regulation in individuals with MS. Individuals
will complete pre- and post-assessments of emotional functioning through a week of daily
diary entries, as well as self-report measures and a behavioral paradigm. Additionally, all
participants will complete an evaluation of neuropsychological functioning, before and after
intervention.

Epidemiological data provides evidence for the manifold increase in rates of depression and
anxiety in individuals diagnosed with multiple sclerosis, relative to the general
population. Such impaired affective processes, including deficits in emotion regulation have
been linked to greater cognitive deficits, a lower quality of life, and greater disease
progression in this population. Despite evidence of the deleterious impact of affective
functioning on prevalence rates of mood and anxiety disorders; on poor cognitive
functioning; and reduced quality of life, much of the targeted intervention research in MS
has not directly tested the feasibility, and subsequent efficacy of a psychosocial
intervention in improving affective regulation in this population. Thus, the investigators
propose to conduct a randomized feasibility study of mindfulness training relative to an
active cognitive training control group and waitlist control group in improving emotional
regulation in individuals with MS. All individuals that contact the Clinical Neuroscience
Laboratory (CNLab) with interest in this study will undergo a phone screening assessing
inclusion/exclusion criteria. Those participants meeting I/E criteria will be invited for an
online daily diaries portion of the study examining daily engagement in worry and
rumination. After completing the week-long daily diary portion of the study, the participant
will attend 1-2 in-person pre-assessment sessions, which will also be completed at the
completion of the four week intervention. The pre-assessment will involve a thorough
assessment of emotion regulation skills, both through self-report questionnaires and
behavioral paradigms, and cognitive functioning. Following the assessment sessions, which
will be conducted by blind assessors, participants will be randomized to the three groups.
The 4-week mindfulness program will be closely modeled after the protocol developed by Dr.
Jon Kabat-Zinn, where investigators will have the participants attend once-per-week sessions
for 2 hours and complete around 40 minutes a day of homework assignments. The four weeks of
mindfulness involve the practice of concentrative attention, where different objects are
used as the focus of practices. For example, for the first two weeks, the investigators use
breath as an anchor for the mind. With repeated practices, the objects of sensations,
emotions, and thought processes are introduced. The classes are a mixture of experiential
practices, discussions surrounding the experiences, and didactics on mindfulness. The
control group, which will be used to compare the effects of mindfulness training on
emotional and cognitive functioning of MS patients, will comprise of a cognitive training
group, which will provide an attentional-training based approach. In this group, our focus
will be to provide the individuals with cognitive training tasks to complete that have been
shown to improve attentional ability. Homework will be reading and practicing using the
cognitive video game exercises for the same duration, around 40 minutes daily, as the
mindfulness group. Following the four weeks of the intervention, the questionnaires,
week-long daily diaries, and behavioral tests from the pretest will be repeated a second
time to obtain post-test data for comparison.

Inclusion Criteria:

1. 30-59 years of age

2. Score higher than or equal to 23 on the Mini Mental Status Examination (MMSE)

3. Corrected (near and far) visual acuity of 20/40 or better

4. No previous experience with mindfulness or continuous meditation practice

5. Absence of other co-morbid neurological disorders

6. Relapse free for the last 30 days

7. No use of corticosteroids for the last 30 days

8. Clinically definite diagnosis of MS

9. Ability to use a computer and connect the internet from their home

10. Generation of at least two worries and two ruminations during the daily diary portion
of the study for the pre-assessment session

Exclusion Criteria:

1. Below 30 years of age or above 59 years of age

2. Score lower than 23 on the MMSE

3. Corrected (near or far) visual acuity of 20/40 or greater

4. Previous experience or participation in a mindfulness program

5. Presence of co-morbid neurological disorders such as:

- Alzheimers

- Parkinson's disease

- Dementia

6. Presence of a relapse within the last 30 days

7. Use of corticosteroids within the last 30 days

8. Clinically isolated syndrome suggestive of MS

9. No ability to use a computer and/or a lack of internet connection from their home

10. No self-generated worries and ruminations in the week-long daily diary portion of the
study at pre-assessment
We found this trial at
1
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Columbus, Ohio 43210
Phone: 614-292-8462
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Columbus, OH
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