Cognitive and Emotion Regulation Training in Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Ohio State University
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Change in Reported Engagement After Worry and Rumination Inductions
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Ruchika Prakash
Assistant Professor
Ohio State University
Eligibility Criteria
Inclusion Criteria
- •30-59 years of age
- •Score higher than or equal to 23 on the Mini Mental Status Examination (MMSE)
- •Corrected (near and far) visual acuity of 20/40 or better
- •No previous experience with mindfulness or continuous meditation practice
- •Absence of other co-morbid neurological disorders
- •Relapse free for the last 30 days
- •No use of corticosteroids for the last 30 days
- •Clinically definite diagnosis of MS
- •Ability to use a computer and connect the internet from their home
- •Generation of at least two worries and two ruminations during the daily diary portion of the study for the pre-assessment session
Exclusion Criteria
- •Below 30 years of age or above 59 years of age
- •Score lower than 23 on the MMSE
- •Corrected (near or far) visual acuity of 20/40 or greater
- •Previous experience or participation in a mindfulness program
- •Presence of co-morbid neurological disorders such as:
- •Alzheimers
- •Parkinson's disease
- •Presence of a relapse within the last 30 days
- •Use of corticosteroids within the last 30 days
- •Clinically isolated syndrome suggestive of MS
Outcomes
Primary Outcomes
Change in Reported Engagement After Worry and Rumination Inductions
Time Frame: Baseline and 4 weeks
Participants will engage in worry and rumination inductions during both the pre- and post-intervention sessions. These worries and ruminations will be sampled from the daily diaries participants will fill out 7-days before the pre- and post-intervention sessions. Investigators will be examining the change in emotion and strategy implementation over the course of the worry and rumination inductions. Specifically, investigators will examine the change in reported negative and positive emotion related to the worry and rumination inductions from pre- to post-intervention. Further, investigators will examine the induction-related change in strategy implementation, specifically worry and rumination, over the 4-weeks of intervention.
Secondary Outcomes
- Improvements on a Self-Report Measures of Anxiety(Baseline and 4 weeks)
- Heart Rate Variability (HRV)(Baseline and 4 weeks)
- Improvements on a Self-Report Measure of Emotion Dysregulation(Baseline and 4 weeks)
- Cognitive Performance on Brief Repeatable Battery (BRB)(Baseline and 4 weeks)
- Daily Emotion Regulation Diary(Baseline and 4 weeks)
- Improvements on a Self-Report Measure of Depression(Baseline and 4 weeks)
- Improvements on a Self-Report Measure of Perceived Stress(Baseline and 4 weeks)
- Improvements on a Self-Report Measure of Quality of Life(Baseline and 4 weeks)