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A Social Emotion Regulation Intervention in MS

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ClinicalTrials.gov Identifier: NCT03951974
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Brief Summary:
The current project will examine effectiveness of an intervention based on the concept of the social regulation of emotion. The intervention is designed to improve well-being in individuals with MS by leveraging participants' existing social support. Effectiveness will be tested on a sample of 42 individuals with MS, half of whom will receive the intervention and half of which will receive an inactive control. Investigators will document changes resulting from treatment on self-reported levels of stress, depression, and quality of life. Intervention evaluation will expand scientific knowledge of emotion regulation disruption in MS, and potentially identify a novel and highly efficient means of treatment.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Emotional Disturbances Behavioral: Social Emotion Regulation Strategy Development Behavioral: Control Not Applicable

Detailed Description:

Multiple sclerosis (MS) is a progressive and debilitating neurological disease which not only affects a patient's physical health, but also adversely affects their mental health. Depressed mood is common in MS, and poor mental health in individuals with MS has wide-ranging consequences on social relationships and community integration. The preponderance of negative emotions and sparsity of positive emotions in MS are attributable in part to ineffective emotion regulation strategies. Thus, the clinical trial seeks to evaluate the effectiveness of an intervention which instructs individuals on using the social regulation of emotion.

The social regulation of emotion occurs when a one's emotional state benefits from an interaction with another person, such as when seeking comfort from a trusted friend. The current intervention was designed to leverage existing social relationships for emotional support in a manner which should strengthen the perception of social support and also reinforce existing relationships. The primary goal of this trial is to examine changes in mental well-being after treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Social Emotion Regulation Intervention in MS
Estimated Study Start Date : May 20, 2019
Estimated Primary Completion Date : May 20, 2019
Estimated Study Completion Date : May 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
Participants in the experimental group will receive training in utilizing social regulation of emotion strategies in an individualized format. They will meet with an interventionist for 5 weeks (1 in-person session and 4 telephone sessions) for 1-1.5 hours each week, and keep a journal documenting their emotion challenges and regulation strategy use.
Behavioral: Social Emotion Regulation Strategy Development
Participants will work one-on-one with an interventionist to develop goals (in the form of implementation intentions) to develop social emotion regulation strategies to combat frequent emotional challenges.

Control
Participants in the control group will not receive training in utilizing social regulation of emotion strategies. While they will still meet with the interventionist on the same schedule and for approximately the same length of time, they will simply be asked to report the emotion regulation strategies that they naturally employ. They will also keep a journal documenting their emotion challenges and regulation strategy use.
Behavioral: Control
Participants will work one-on-one with an interventionist to report on their frequent emotional challenges, and report the emotion regulation strategies that they frequently use to combat them.




Primary Outcome Measures :
  1. Well-being: Depression [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]
    Change in scores on a self-report questionnaire of depression

  2. Well-being: Stress [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]
    Change in scores on a self-report questionnaire of stress

  3. Well-being: Quality of life [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]
    Change in scores on a self-report questionnaire of quality of life


Secondary Outcome Measures :
  1. Perceived social support [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6) ]
    Change in scores on a self-report questionnaire of perceived social support



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple Sclerosis diagnosis
  • English language fluency

Exclusion Criteria:

  • currently taking steroids or benzodiazepines
  • within 30 days of an exacerbation
  • history of substance abuse
  • diagnosis of bipolar, schizophrenia, epilepsy, stroke

Information from the National Library of Medicine

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): NCT03951974


Contacts
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Contact: Katie Lancaster, PhD 973-324-8431 klancaster@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Not yet recruiting
East Hanover, New Jersey, United States, 07936
Contact: Katie Lancaster, PhD    973-324-8431    klancaster@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Katie Lancaster, PhD Kessler Foundation

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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT03951974     History of Changes
Other Study ID Numbers: PC 8-19
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Kessler Foundation:
emotion regulation
social regulation of emotion

Additional relevant MeSH terms:
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Multiple Sclerosis
Affective Symptoms
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Behavioral Symptoms