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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934489
• Other study ID #: IRB00199623
• Secondary ID: PP-1804-30860
• Status: Completed
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: March 15, 2021

Study information

• Verified date: March 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• PERSIST
12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
• Facilitated Peer Support
12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 13 and 26 weeks
Primary	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.	Baseline, 13 and 26 weeks
Secondary	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.	Baseline, 13 and 26 weeks
Secondary	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.	Baseline, 13 and 26 weeks
Secondary	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.	Baseline, 13 weeks, and 26 weeks
Secondary	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.	Baseline, 13 weeks, and 26 weeks