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Clinical Trials/NCT03951974
NCT03951974
Unknown
Not Applicable

A Social Emotion Regulation Intervention in MS

Kessler Foundation1 site in 1 country42 target enrollmentJuly 9, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Kessler Foundation
Enrollment
42
Locations
1
Primary Endpoint
Well-being: Depression
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 9, 2019
End Date
July 9, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Well-being: Depression

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

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)

Well-being: Stress

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

Change in scores on a self-report questionnaire of stress (the Perceived Stress Scale, a 10-item scale with higher scores reflecting higher stress)

Well-being: Quality of life

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

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)

Secondary Outcomes

  • Perceived social support(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 6))

Study Sites (1)

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