Emotion Regulation Skills Training for Individuals With MS and Their Support Partners

March 23, 2021 updated by: Johns Hopkins University

Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention

This pilot randomized controlled trial investigates a novel, group-based emotion regulation skills training intervention for reducing anxious and depressive symptomatology and improving emotion regulation and problem solving in individuals with MS and the individual's support partners. Participants will be randomized (1:1) to the intervention ("Partnered Emotion Regulation Skills Intervention and Supportive Teaching [PERSIST]") or to the active control (Facilitated Peer Support).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • able to speak/read in English
  • able to commit to attending at least 9 of the 12 weekly group sessions
  • individuals with MS must be relapse/exacerbation-free for at least 1 month
  • support partners must score at least 8 on the HADS-D or HADS-A
  • individuals with MS must score a least 11 on the HADS-D or HADS-A

Exclusion Criteria:

  • under 18 years old
  • unable to speak/read in English
  • unable to commit to attending at least 9 of the 12 weekly group sessions
  • MS relapse within 1 month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PERSIST
Participants will receive Partnered Emotion Regulation Skills Intervention and Support.
Behavioral: PERSIST
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
Active Comparator: Facilitated Peer Support
Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
Behavioral: Facilitated Peer Support
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
Time Frame: Baseline, 13 and 26 weeks
The HADS-D is a 7-item subscale of the HADS that measures depressive symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater depressive symptomatology.
Baseline, 13 and 26 weeks
Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: Baseline, 13 and 26 weeks
The HADS-A is a 7-item subscale of the HADS that measures anxious symptomatology. Scores range from 0 to 21 points (each item is rated 0-4), with higher scores indicating greater anxious symptomatology.
Baseline, 13 and 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Difficulties in Emotion Regulation Scale (DERS-16) score
Time Frame: Baseline, 13 and 26 weeks
The DERS-16 is a 16-item self-report measures that assesses difficulties with managing negative emotions, distress, and impulsivity. Scores range from 16 to 80 points (each item is rated 1-5), with higher scores indicating greater emotional dysregulation.
Baseline, 13 and 26 weeks
Change in Problem Solving Inventory (PSI) score
Time Frame: Baseline, 13 and 26 weeks
The PSI is a 32-item self-report instrument designed to assess perceived problem solving abilities. Scores range from 32 to 192 points (each item is rated 1-6), with higher scores indicating greater difficulty with problem solving.
Baseline, 13 and 26 weeks
Change in RAND 36-Item Short Form Health Survey (SF-36) score
Time Frame: Baseline, 13 weeks, and 26 weeks
The SF-36 is a 36-item self-report measure of health-related quality of life. The scale is divided into 8 subscales, each ranging from 0 to 100 points, with higher scores indicating better health-related quality of life.
Baseline, 13 weeks, and 26 weeks
Change in Zarit Burden Interview (ZBI) score
Time Frame: Baseline, 13 weeks, and 26 weeks
The ZBI is a 22-item self-report measure of caregiver burden. Scores range from 0 to 88 (each item is rated 0-4), with higher scores indicating greater burden.
Baseline, 13 weeks, and 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Abbey Hughes, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2020

Primary Completion (Actual)

March 15, 2021

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

April 29, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

May 2, 2019

Study Record Updates

Last Update Posted (Actual)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00199623
  • PP-1804-30860 (Other Grant/Funding Number: National Multiple Sclerosis Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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