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

CompletedNot a drug-phase studyMS (type not specified)NCT03934489

What it found

No results found

We found no results in the registry or in papers.

This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • PERSIST

Compared with

  • Facilitated Peer Support

What it measured

Main measures

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

    Baseline, 13 and 26 weeks

    Mood and sleep
  • Change in Anxiety Subscale score of the Hospital Anxiety and Depression Scale (HADS-A)

    Baseline, 13 and 26 weeks

    Mood and sleep

Other measures (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

    Quality of life (reported by participants)
  • Change in Zarit Burden Interview (ZBI) score

    Baseline, 13 weeks, and 26 weeks

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Jan 2020

    2. Main results due

      Mar 2021

    3. Finished

      Mar 2021

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