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临床试验/NCT02717429
NCT02717429已完成不适用

Cognitive and Emotion Regulation Training in Multiple Sclerosis

Ohio State University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
2
主要终点
Change in Reported Engagement After Worry and Rumination Inductions

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 30-59 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

排除标准

  • 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
  • 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

研究组 & 干预措施

Mindfulness Meditation Training (MMT)

Experimental

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.

干预措施: Mindfulness Meditation (Behavioral)

Computerized Cognitive Training

Active Comparator

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.

干预措施: Computerized Cognitive Training (Behavioral)

Wait-List Control Group

No Intervention

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.

结局指标

主要结局

Change in Reported Engagement After Worry and Rumination Inductions

时间窗: 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.

次要结局

  • Improvements on a Self-Report Measures of Anxiety(Baseline and 4 weeks)
  • Heart Rate Variability (HRV)(Baseline and 4 weeks)
  • Improvements on a Self-Report Measure of Emotion Dysregulation(Baseline and 4 weeks)
  • Cognitive Performance on Brief Repeatable Battery (BRB)(Baseline and 4 weeks)
  • Daily Emotion Regulation Diary(Baseline and 4 weeks)
  • Improvements on a Self-Report Measure of Depression(Baseline and 4 weeks)
  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruchika Prakash

Assistant Professor

Ohio State University

研究点 (2)

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