Clinical trial NCT03951974: A Social Emotion Regulation Intervention in MS
Official title: A Social Emotion Regulation Intervention in MS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Emotional Disturbances
Keywords: emotion regulation
social regulation of emotion
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Well-being: Depression
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
measure: Well-being: Stress
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
measure: Well-being: Quality of life
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Secondary outcomes:
measure: Perceived social support
timeFrame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Katie Lancaster, PhD
role: PRINCIPAL_INVESTIGATOR
References: