Cognitive and Emotion Regulation Training in MS
CERT-MS
1 other identifier
interventional
62
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable multiple-sclerosis
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 14, 2017
CompletedApril 17, 2018
April 1, 2018
1.6 years
October 21, 2015
April 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Reported Engagement After Worry and Rumination Inductions
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.
Baseline and 4 weeks
Secondary Outcomes (8)
Cognitive Performance on Brief Repeatable Battery (BRB)
Baseline and 4 weeks
Heart Rate Variability (HRV)
Baseline and 4 weeks
Daily Emotion Regulation Diary
Baseline and 4 weeks
Improvements on a Self-Report Measure of Emotion Dysregulation
Baseline and 4 weeks
Improvements on a Self-Report Measure of Depression
Baseline and 4 weeks
- +3 more secondary outcomes
Study Arms (3)
Mindfulness Meditation Training (MMT)
EXPERIMENTALParticipants will attend four weekly group mindfulness meditation sessions of a 2-hour duration. The classes are a mixture of experiential practices, discussions surrounding the experiences, and didactics on mindfulness. In addition to the time spent in session, participants will be asked to complete 40 minutes of daily homework, which includes further practice of in-session meditative exercises and brief readings.
Computerized Cognitive Training
ACTIVE COMPARATORThe active control group will be in the form of a cognitive training course where the participants will meet for the same amount of time as the MMT group. Homework will be reading and engaging in cognitive video game exercises for the same duration, around 40 minutes daily, as the MMT group.
Wait-List Control Group
NO INTERVENTIONThis group will be used to compare the effects of the two active comparison groups and will not receive any intervention for the four week period.
Interventions
The mindfulness meditation-training program is closely modeled after the 8-week mindfulness based stress reduction protocol developed by Dr. Jon Kabat-Zinn. The briefer four weeks of MMT involve the practice of concentrative attention, where different objects are used as the focus of meditative practices. For example, for the first two weeks, the investigators use breath as an anchor for attention. With repeated practices, the objects of sensations, emotions, and thought processes are introduced.
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, the focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. The investigators will also discuss relevant MS-related material on cognitive deficits during these courses.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Dementia
- Presence of a relapse within the last 30 days
- Use of corticosteroids within the last 30 days
- Clinically isolated syndrome suggestive of MS
- No ability to use a computer and/or a lack of internet connection from their home
- No self-generated worries and ruminations in the week-long daily diary portion of the study at pre-assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210, United States
Related Publications (3)
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.
PMID: 35901401DERIVEDSchirda 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.
PMID: 32378922DERIVEDManglani 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.
PMID: 32352832DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruchika S Prakash, PhD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 21, 2015
First Posted
March 23, 2016
Study Start
October 1, 2015
Primary Completion
May 14, 2017
Study Completion
May 14, 2017
Last Updated
April 17, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share