Clinical trial NCT02717429: Cognitive and Emotion Regulation Training in MS
Official title: Cognitive and Emotion Regulation Training in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2016-03-23
Enrollment: 62
Sex: ALL
Minimum age (years): 30
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Reported Engagement After Worry and Rumination Inductions
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Cognitive Performance on Brief Repeatable Battery (BRB)
timeFrame: Baseline and 4 weeks
measure: Heart Rate Variability (HRV)
timeFrame: Baseline and 4 weeks
measure: Daily Emotion Regulation Diary
timeFrame: Baseline and 4 weeks
measure: Improvements on a Self-Report Measure of Emotion Dysregulation
timeFrame: Baseline and 4 weeks
measure: Improvements on a Self-Report Measure of Depression
timeFrame: Baseline and 4 weeks
measure: Improvements on a Self-Report Measures of Anxiety
timeFrame: Baseline and 4 weeks
measure: Improvements on a Self-Report Measure of Perceived Stress
timeFrame: Baseline and 4 weeks
measure: Improvements on a Self-Report Measure of Quality of Life
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Department of Psychology, The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Ruchika S Prakash, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duraney EJ, Fisher ME, Manglani HR, Andridge RR, Nicholas JA, Prakash RS. Impact of mindfulness training on emotion regulation in multiple sclerosis: Secondary analysis of a pilot randomized controlled trial. Rehabil Psychol. 2022 Nov;67(4):449-460. doi: 10.1037/rep0000456. Epub 2022 Jul 28.
citation: Schirda B, Duraney E, Lee HK, Manglani HR, Andridge RR, Plate A, Nicholas JA, Prakash RS. Mindfulness training for emotion dysregulation in multiple sclerosis: A pilot randomized controlled trial. Rehabil Psychol. 2020 Aug;65(3):206-218. doi: 10.1037/rep0000324. Epub 2020 May 7.
citation: Manglani HR, Samimy S, Schirda B, Nicholas JA, Prakash RS. Effects of 4-week mindfulness training versus adaptive cognitive training on processing speed and working memory in multiple sclerosis. Neuropsychology. 2020 Jul;34(5):591-604. doi: 10.1037/neu0000633. Epub 2020 Apr 30.