Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04688710

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Self-Hypnosis (HYP)
  • Mindfulness Meditation (MM)

What it measured

Main measures

  • Change in Fatigue Severity

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Thinking and memoryFatigue

Other measures (12)

  • Change in Sleep Quality assessed via PROMIS Sleep Disturbance Short Form 4a, version 1.0

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Mood and sleepQuality of life (reported by participants)
  • Change in Pain Interference

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    PainQuality of life (reported by participants)
  • Change in Pain Intensity and Fatigue (current)

    Immediately before and after listening to treatment audio recordings

    FatiguePain
  • Change in Pain Intensity (past week)

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Pain
  • Change in Depressive Symptoms

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Mood and sleepQuality of life (reported by participants)
  • Change in Anxiety

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Mood and sleepQuality of life (reported by participants)
  • Change in Physical Function

    Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Quality of life (reported by participants)
  • Treatment Preference

    Baseline (prior to treatment)

  • Device Use for Treatment

    Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

  • Change in Global Impression of Change

    Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

    Fatigue

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

1. Self-reported diagnosis of MS. 2. Age 18 years old or older at the time of study enrollment. 3. Presenting with clinically meaningful fatigue (i.e., reporting daily fatigue ≥50% of the days in the past 6 months with an average severity in the past week of ≥ 20 on the PROMIS Fatigue short form [T-score, 56.4]). 4. Able to read, speak, and understand English. 5. Access to an internet-enabled device (desktop/laptop/tablet/smart phone) to allow access to the recordings and to complete the study measures via the internet.

Exclusion criteria

1. Psychiatric condition or symptoms that would interfere with participation, specifically (a) current active suicidal ideation with current intent to harm oneself, (b) current psychosis, or (c) current mania. 2. Currently receiving psychological treatment for fatigue more than once per month. 3. Has received mindfulness meditation or hypnosis training in the past and has practiced mindfulness meditation/hypnosis in the past three months.

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

About this trial

In the sponsor's words

The purpose of this study is to assess the effectiveness of two self-guided psychological treatments, Self-Hypnosis (HYP) and Mindfulness Meditation (MM) compared to Treatment as Usual (TAU) for people with multiple sclerosis (MS) and clinically significant fatigue.

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History

    1. Started

      Apr 2021

    2. Main results due

      Jun 2023

    3. Finished

      Dec 2023

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