Cognitive and Emotion Regulation Training in MS

NCT ID: NCT02717429

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-05-14

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Mindfulness Meditation

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Computerized Cognitive Training

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ruchika Prakash

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruchika S Prakash, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Department of Psychology, The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35901401 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32378922 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32352832 (View on PubMed)

Other Identifiers

2014H0212

Identifier Type: -

Identifier Source: org_study_id