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Completed

NCT Number: NCT03934489

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

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).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PERSIST

Behavioral

12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.

Facilitated Peer Support

Behavioral

12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 2, 2019
Registry last updated
Mar 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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