A Social Emotion Regulation Intervention in MS

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Multiple Sclerosis; Emotional Disturbances
• Intervention / Treatment: Behavioral: Social Emotion Regulation Strategy Development; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
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)	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
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)	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Investigators: Principal Investigator: Katie Lancaster, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2019
• Primary Completion (Anticipated): July 9, 2021
• Study Completion (Anticipated): July 9, 2021

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 14, 2019
• First Posted (Actual): May 16, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: emotion regulation; social regulation of emotion
• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Affective Symptoms
• Other Study ID Numbers: PC 8-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No