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

NCT ID: NCT03934489

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-07

Study Completion Date

2021-03-15

Brief Summary

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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).

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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PERSIST

Participants will receive Partnered Emotion Regulation Skills Intervention and Support.

Group Type EXPERIMENTAL

PERSIST

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Facilitated Peer Support

Intervention Type BEHAVIORAL

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

Interventions

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PERSIST

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

Intervention Type BEHAVIORAL

Facilitated Peer Support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Multiple Sclerosis Society

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abbey Hughes, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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PP-1804-30860

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB00199623

Identifier Type: -

Identifier Source: org_study_id

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