Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study

CompletedNot a drug-phase studyMS (type not specified)NCT04429789

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

  • Active-Alert Hypnosis
  • Traditional Hypnosis

What it measured

Main measures

  • Fatigue Self Efficacy

    Assessed via telephone within a 1-week period at baseline (prior to randomization)

    Fatigue
  • Fatigue Self Efficacy

    Third week: mid-treatment (after second session)

    Fatigue
  • Fatigue Self Efficacy

    Fifth week: post-treatment (after fourth session)

    Fatigue
  • Fatigue Self Efficacy

    4 months: 3 month follow-up

    Fatigue
  • Fatigue Severity

    Assessed via telephone within a 1-week period at baseline (prior to randomization)

    Fatigue
  • Fatigue Severity

    Third week: mid-treatment (after second session)

    Fatigue
  • Fatigue Severity

    Fifth week: post-treatment (after fourth session)

    Fatigue
  • Fatigue Severity

    4 months: 3 month follow-up

    Fatigue

Other measures (23)

  • Psychological and Physical Function

    Assessed via telephone within a 1-week period at baseline (prior to randomization)

  • Psychological and Physical Function

    Third week: mid-treatment (after second session)

  • Psychological and Physical Function

    Fifth week: post-treatment (after fourth session)

  • Psychological and Physical Function

    4 months: 3 month follow-up

  • Activity Level

    Assessed via telephone within a 1-week period at baseline (prior to randomization)

    Physical function
  • Activity Level

    Third week: mid-treatment (after second session)

    Physical function
  • Activity Level

    Fifth week: post-treatment (after fourth session)

    Physical function
  • Activity Level

    4 months: 3 month follow-up

    Physical function
  • Suggestibility

    Within a 1-week period at baseline (prior to randomization)

  • Suggestibility

    Fifth week: post-treatment (after fourth session)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of MS; * Adults 18 years of age or older; * Bothersome fatigue (defined as the presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months and average Fatigue Severity Scale score > to 4 at screening); * Ability to read, speak, and understand English and/or Spanish.

Exclusion criteria

* Exclusion criteria will be evidence for significant psychopathology that would interfere with study participation, including current suicidal ideation with intent, active psychosis or hallucinations, or severe cognitive impairment.

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

About this trial

In the sponsor's words

The proposed study is a single-center, single-blind three-group randomized (1:1:1) controlled trial (RCT) comparing two hypnosis interventions to waitlist control efficacy for MS-related fatigue.

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History

    1. Started

      May 2020

    2. Main results due

      Mar 2021

    3. Finished

      Mar 2021

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