Cognitive and Emotion Regulation Training in MS (CERT-MS)

• ClinicalTrials.gov Identifier: NCT02717429
• Recruitment Status: Completed
• First Posted: March 23, 2016
• Last Update Posted: April 17, 2018
• Sponsor: Ohio State University
• Information provided by (Responsible Party): Ruchika Prakash, Ohio State University

Tracking Information

• First Submitted Date: October 21, 2015
• First Posted Date: March 23, 2016
• Last Update Posted Date: April 17, 2018
• Study Start Date: October 2015
• Actual Primary Completion Date: May 14, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 17, 2016)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 17, 2016)

• Cognitive Performance on Brief Repeatable Battery (BRB) [ Time Frame: Baseline and 4 weeks ]
  Participants will perform the entire Brief Repeatable Battery before and after the intervention. Using the categorization developed by Sepulcher (2013), the 5 tests of the BRB will be analyzed using four cognitive domains: attention and executive functioning, verbal memory, visual memory, and word fluency. Based on the computerized cognitive training protocol employed in the current study, investigators hypothesize changes in attention and executive functioning along with visual memory in participants in the cognitive training group, followed by participants in the MMT group compared with the wait-list control participants.
• Heart Rate Variability (HRV) [ Time Frame: Baseline and 4 weeks ]
  HRV data will be collected during worry and rumination inductions, as participants regulate their emotions, and at rest.
• Daily Emotion Regulation Diary [ Time Frame: Baseline and 4 weeks ]
  Participants will be asked to fill out worry and ruminations using a diary-based methodology a week before the pre-intervention behavioral session and one week after the post-intervention sessions. Changes in average self-reported worry and rumination intensity, emotion regulation strategy use, and successful emotion regulation strategy implementation will be examined as a function of the intervention.
• Improvements on a Self-Report Measure of Emotion Dysregulation [ Time Frame: Baseline and 4 weeks ]
  Emotion Dysregulation will be assessed using the Difficulties in Emotion Regulation Scale (DERS). Changes on the total score and sub-facets of DERS will be examined as a function of the intervention.
• Improvements on a Self-Report Measure of Depression [ Time Frame: Baseline and 4 weeks ]
  Participants will be administered Beck Depression Inventory before and after the intervention. Change on this measure will be examined to assess the impact of the interventions on symptoms of depression.
• Improvements on a Self-Report Measures of Anxiety [ Time Frame: Baseline and 4 weeks ]
  Participants will be administered Penn State Worry Questionnaire before and after the intervention. Change on this measure will be examined to assess the impact of the interventions on symptoms of worry.
• Improvements on a Self-Report Measure of Perceived Stress [ Time Frame: Baseline and 4 weeks ]
  Participants will be administered the Perceived Stress Scale before and after the intervention. Changes in these measures will be examined as a function of the intervention.
• Improvements on a Self-Report Measure of Quality of Life [ Time Frame: Baseline and 4 weeks ]
  Participants will be administered the Satisfaction with Life Scale before and after the intervention. Change in scores of this measure will be examined to assess changes in quality of life as a function of the interventions.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive and Emotion Regulation Training in MS
• Official Title: Cognitive and Emotion Regulation Training in Multiple Sclerosis
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• Behavioral: Mindfulness Meditation
  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.
• Behavioral: Computerized Cognitive Training
  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.

Study Arms

• Experimental: Mindfulness Meditation Training (MMT)
  Participants 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.
  Intervention: Behavioral: Mindfulness Meditation
• Active Comparator: Computerized Cognitive Training
  The 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.
  Intervention: Behavioral: Computerized Cognitive Training
• No Intervention: Wait-List Control Group
  This 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.

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 13, 2018): 62
• Original Estimated Enrollment (submitted: March 17, 2016): 60
• Actual Study Completion Date: May 14, 2017
• Actual Primary Completion Date: May 14, 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02717429
• Other Study ID Numbers: 2014H0212
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Ruchika Prakash, Ohio State University
• Study Sponsor: Ohio State University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ruchika S Prakash, PhD; Ohio State University

• PRS Account: Ohio State University
• Verification Date: April 2018