A Social Emotion Regulation Intervention in MS

Kessler Foundation

Status: Unknown

Conditions: Emotional Disturbances; Multiple Sclerosis

Treatments: Behavioral: Control; Behavioral: Social Emotion Regulation Strategy Development

Study type: Interventional

Funder types: Other

Identifiers

NCT03951974

PC 8-19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 2 patient groups

Experimental

Experimental group

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.

Treatment:

Behavioral: Social Emotion Regulation Strategy Development

Control

Other group

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.

Treatment:

Behavioral: Control