NCT03934489

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 2, 2019

Completed
8 months until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

April 29, 2019

Last Update Submit

March 23, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Change in Difficulties in Emotion Regulation Scale (DERS-16) score

    Baseline, 13 and 26 weeks

  • Change in Problem Solving Inventory (PSI) score

    Baseline, 13 and 26 weeks

  • Change in RAND 36-Item Short Form Health Survey (SF-36) score

    Baseline, 13 weeks, and 26 weeks

  • Change in Zarit Burden Interview (ZBI) score

    Baseline, 13 weeks, and 26 weeks

Study Arms (2)

PERSIST

EXPERIMENTAL

Participants will receive Partnered Emotion Regulation Skills Intervention and Support.

Behavioral: PERSIST

Facilitated Peer Support

ACTIVE COMPARATOR

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

Interventions

PERSISTBEHAVIORAL

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

PERSIST
Facilitated Peer SupportBEHAVIORAL

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

Facilitated Peer Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Abbey Hughes, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2019

First Posted

May 2, 2019

Study Start

January 7, 2020

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

US(1)