Cognitive and Emotion Regulation Training in MS (CERT-MS)
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|ClinicalTrials.gov Identifier: NCT02717429|
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : April 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Mindfulness Meditation Behavioral: Computerized Cognitive Training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive and Emotion Regulation Training in Multiple Sclerosis|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||May 14, 2017|
|Actual Study Completion Date :||May 14, 2017|
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.
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.
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.
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.
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717429
|United States, Ohio|
|Department of Psychology, The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ruchika S Prakash, PhD||Ohio State University|