A Social Emotion Regulation Intervention in MS

NCT ID: NCT03951974

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-09
• Study Completion Date: 2021-07-09

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.

Conditions

Multiple Sclerosis; Emotional Disturbances

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Experimental

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.

Group Type: EXPERIMENTAL

Social Emotion Regulation Strategy Development

Intervention Type: BEHAVIORAL

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 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.

Group Type: OTHER

Control

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kessler Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Katie Lancaster, PhD

Role: PRINCIPAL_INVESTIGATOR

Kessler Foundation

Locations

Kessler Foundation

East Hanover, New Jersey, United States

Countries

United States

Other Identifiers

PC 8-19

Identifier Type: -

Identifier Source: org_study_id