Cognitive and Emotion Regulation Training in MS

Multiple Sclerosis Clinical Trial

— CERT-MS  

Official title:

Cognitive and Emotion Regulation Training in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02717429
• Other study ID #: 2014H0212
• Status: Completed
• Phase: N/A
• First received: October 21, 2015
• Last updated: April 13, 2018
• Start date: October 2015
• Est. completion date: May 14, 2017

Study information

• Verified date: April 2018
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: May 14, 2017
• Est. primary completion date: May 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• 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.
• 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.

Locations

Country	Name	City	State
United States	Department of Psychology, The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cognitive Performance on Brief Repeatable Battery (BRB)	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.	Baseline and 4 weeks
Secondary	Heart Rate Variability (HRV)	HRV data will be collected during worry and rumination inductions, as participants regulate their emotions, and at rest.	Baseline and 4 weeks
Secondary	Daily Emotion Regulation Diary	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.	Baseline and 4 weeks
Secondary	Improvements on a Self-Report Measure of Emotion Dysregulation	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.	Baseline and 4 weeks
Secondary	Improvements on a Self-Report Measure of Depression	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.	Baseline and 4 weeks
Secondary	Improvements on a Self-Report Measures of Anxiety	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.	Baseline and 4 weeks
Secondary	Improvements on a Self-Report Measure of Perceived Stress	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.	Baseline and 4 weeks
Secondary	Improvements on a Self-Report Measure of Quality of Life	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.	Baseline and 4 weeks