A Social Emotion Regulation Intervention in MS

Multiple Sclerosis Clinical Trial

Official title:

A Social Emotion Regulation Intervention in MS

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03951974
• Other study ID #: PC 8-19
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 9, 2019
• Est. completion date: July 9, 2021

Study information

• Verified date: May 2021
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 42
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Affective Symptoms
• Emotional Disturbances
• Multiple Sclerosis

Intervention

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 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)