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A Social Emotion Regulation Intervention in MS

Primary Purpose

Multiple Sclerosis, Emotional Disturbances

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Emotion Regulation Strategy Development
Control
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Multiple Sclerosis focused on measuring emotion regulation, social regulation of emotion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Well-being: Depression
Change in scores on a self-report questionnaire of depression (the Center for Epidemiologic Studies Depression Scale, a 20-item scale with higher scores indicating greater depression)
Well-being: Stress
Change in scores on a self-report questionnaire of stress (the Perceived Stress Scale, a 10-item scale with higher scores reflecting higher stress)
Well-being: Quality of life
Change in scores on a self-report questionnaire of quality of life (the Satisfaction with Life Scale, a five item scale where higher scores reflect higher satisfaction)

Secondary Outcome Measures

Perceived social support
Change in scores on a self-report questionnaire of perceived social support (the Multidimensional Scale of Perceived Social Support, a 12-item scale where higher scores reflect greater support)

Full Information

First Posted
May 13, 2019
Last Updated
May 4, 2021
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03951974
Brief Title
A Social Emotion Regulation Intervention in MS
Official Title
A Social Emotion Regulation Intervention in MS
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2019 (Actual)
Primary Completion Date
July 9, 2021 (Anticipated)
Study Completion Date
July 9, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Emotional Disturbances
Keywords
emotion regulation, social regulation of emotion

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Emotion Regulation Strategy Development
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Well-being: Depression
Description
Change in scores on a self-report questionnaire of depression (the Center for Epidemiologic Studies Depression Scale, a 20-item scale with higher scores indicating greater depression)
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Title
Well-being: Stress
Description
Change in scores on a self-report questionnaire of stress (the Perceived Stress Scale, a 10-item scale with higher scores reflecting higher stress)
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Title
Well-being: Quality of life
Description
Change in scores on a self-report questionnaire of quality of life (the Satisfaction with Life Scale, a five item scale where higher scores reflect higher satisfaction)
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Secondary Outcome Measure Information:
Title
Perceived social support
Description
Change in scores on a self-report questionnaire of perceived social support (the Multidimensional Scale of Perceived Social Support, a 12-item scale where higher scores reflect greater support)
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Lancaster, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified Individual participant data that underlie publication in an article will be shared.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Any purpose

Learn more about this trial

A Social Emotion Regulation Intervention in MS

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