A Social Emotion Regulation Intervention in MS

NCT03951974 | Unknown

• 1 other identifier: PC 8-19
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Emotional Disturbances

Keywords

emotion regulation; social regulation of emotion

Outcome Measures

Primary Outcomes (3)

• Well-being: Depression

  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)

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

• Well-being: Stress

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

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

• Well-being: Quality of life

  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)

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

Secondary Outcomes (1)

• Perceived social support

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

Study Arms (2)

Experimental

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.

Behavioral: Social Emotion Regulation Strategy Development

Control

OTHER

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.

Behavioral: Control

Interventions

Social Emotion Regulation Strategy Development 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.

Experimental

Control 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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Multiple Sclerosis diagnosis
• English language fluency

You may not qualify if:

• currently taking steroids or benzodiazepines
• within 30 days of an exacerbation
• history of substance abuse
• diagnosis of bipolar, schizophrenia, epilepsy, stroke

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Affective Symptoms; Emotional Regulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Self-Control; Social Behavior

Study Officials

• Katie Lancaster, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 16, 2019
• Study Start: July 9, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Any purpose

Locations

US (1)