Cognitive and Emotion Regulation Training in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02717429

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Mindfulness Meditation

Compared with

  • Computerized Cognitive Training

What it measured

Main measures

  • Change in Reported Engagement After Worry and Rumination Inductions

    Baseline and 4 weeks

Other measures (8)

  • Cognitive Performance on Brief Repeatable Battery (BRB)

    Baseline and 4 weeks

    Thinking and memory
  • 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

    Mood and sleep
  • Improvements on a Self-Report Measures of Anxiety

    Baseline and 4 weeks

    Mood and sleep
  • Improvements on a Self-Report Measure of Perceived Stress

    Baseline and 4 weeks

  • Improvements on a Self-Report Measure of Quality of Life

    Baseline and 4 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 30 to 59

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Oct 2015

    2. Main results due

      May 2017

    3. Finished

      May 2017

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