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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03934489

Recruitment Status Recruiting

First Posted May 2, 2019

Last update posted August 18, 2020

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:Multiple Sclerosis
  • Intervention/Treatment: Behavioral: PERSIST
    Behavioral: Facilitated Peer Support
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated 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: January 2020
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: March 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) [ 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.
  • 2. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts

Contact: Abbey Hughes, PhD 410-502-9234 abbeyjhughes@jhmi.edu

Contact: Meghan Beier, PhD 410-502-2441 mbeier1@jhu.edu

Locations

United States, Maryland
Johns Hopkins University
Baltimore

Sponsors and Collaborators

Johns Hopkins University

National Multiple Sclerosis Society

Investigators

Principal Investigator: Abbey Hughes, PhD Johns Hopkins University

More Information
  • Responsible Party: Johns Hopkins University
  • ClinicalTrials.gov Identifier: NCT03934489 History of Changes
  • Other Study ID Numbers: IRB00199623, PP-1804-30860
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: August 18, 2020
  • Last Verified: August 2020
  • 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