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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03934489
• Collaborator: National Multiple Sclerosis Society (Other)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.2
• Patients Per Site Per Month: 2.8

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Behavioral: PERSIST; Behavioral: Facilitated Peer Support	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Reducing Depression and Anxiety in Individuals With Multiple Sclerosis (MS) and Their Support Partners: An Emotion Regulation Skills Training Intervention
• Actual Study Start Date: Jan 7, 2020
• Actual Primary Completion Date: Mar 15, 2021
• Actual Study Completion Date: Mar 15, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Depression Subscale score of the Hospital Anxiety and Depression Scale (HADS-D) [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.

2. Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A) [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.

Secondary Outcome Measures

1. Change in Difficulties in Emotion Regulation Scale (DERS-16) score [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.

2. Change in Problem Solving Inventory (PSI) score [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.

3. Change in RAND 36-Item Short Form Health Survey (SF-36) score [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.

4. Change in Zarit Burden Interview (ZBI) score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Multiple Sclerosis Society

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT03934489
• Other Study ID Numbers: IRB00199623; PP-1804-30860
• First Posted: May 2, 2019
• Last Update Posted: Mar 24, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Mar 24, 2021