Back to resultsEmotion Regulation Skills Training for Individuals With MS and Their Support Partners
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PERSIST
Facilitated Peer Support
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PERSIST
Facilitated Peer Support
Arm Description
Participants will receive Partnered Emotion Regulation Skills Intervention and 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.
Outcomes
Primary Outcome Measures
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
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.
Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)
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.
Secondary Outcome Measures
Change in Difficulties in Emotion Regulation Scale (DERS-16) score
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.
Change in Problem Solving Inventory (PSI) score
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.
Change in RAND 36-Item Short Form Health Survey (SF-36) score
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.
Change in Zarit Burden Interview (ZBI) score
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.
Full Information
NCT ID
NCT03934489
First Posted
April 29, 2019
Last Updated
March 23, 2021
Sponsor
Johns Hopkins University
Collaborators
National Multiple Sclerosis Society
1. Study Identification
Unique Protocol Identification Number
NCT03934489
Brief Title
Emotion Regulation Skills Training for Individuals With MS and Their Support Partners
Official Title
Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
March 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Multiple Sclerosis Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PERSIST
Arm Type
Experimental
Arm Description
Participants will receive Partnered Emotion Regulation Skills Intervention and Support.
Arm Title
Facilitated Peer Support
Arm Type
Active Comparator
Arm Description
Participants will undergo a 12-week group intervention, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
Intervention Type
Behavioral
Intervention Name(s)
PERSIST
Intervention Description
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
Intervention Type
Behavioral
Intervention Name(s)
Facilitated Peer Support
Intervention Description
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
Primary Outcome Measure Information:
Title
Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D)
Description
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.
Time Frame
Baseline, 13 and 26 weeks
Title
Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)
Description
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.
Time Frame
Baseline, 13 and 26 weeks
Secondary Outcome Measure Information:
Title
Change in Difficulties in Emotion Regulation Scale (DERS-16) score
Description
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.
Time Frame
Baseline, 13 and 26 weeks
Title
Change in Problem Solving Inventory (PSI) score
Description
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.
Time Frame
Baseline, 13 and 26 weeks
Title
Change in RAND 36-Item Short Form Health Survey (SF-36) score
Description
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.
Time Frame
Baseline, 13 weeks, and 26 weeks
Title
Change in Zarit Burden Interview (ZBI) score
Description
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.
Time Frame
Baseline, 13 weeks, and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbey Hughes, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Emotion Regulation Skills Training for Individuals With MS and Their Support Partners
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