NCT03951974

A Social Emotion Regulation Intervention in MS

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis
• Emotional Disturbances

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-07-09
• Primary completion: 2021-07-09
• Completion: 2021-07-09
• First posted: 2019-05-16
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States