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CompletedNCT04429789POWER-UPUpdated May 3, 2021

Waking Hypnosis in the Treatment of MS-related Fatigue

An interventional study of Active-Alert Hypnosis and Traditional Hypnosis in Multiple Sclerosis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by University of Washington · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This project will test the efficacy of two different hypnosis approaches for improving MS-related fatigue that have shown to be beneficial for individuals with cancer and other medical conditions in the management of their symptoms. One of these methods, the active-alert hypnosis has helped people to manage fatigue and may have important advantages over the more traditional relaxation hypnotic approaches in the treatment of fatigue, since the hypnotic inductions and the self-hypnosis methods use activation instead of relaxation. Therefore, the goals of this study are to determine if a comparison study of these two hypnotic conditions is feasible, and, if so, to determine which treatment may be more effective for helping individuals with MS gain more control over fatigue. Additionally, it will explore the mechanisms of these two approaches to hypnosis treatment to determine which might be most helpful to individuals with MS and fatigue.

02

Conditions studied

  • Multiple Sclerosis

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03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 32 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Active-Alert Hypnosis

    Behavioral: Active-Alert Hypnosis

  • Experimental
    Traditional Hypnosis

    Behavioral: Traditional Hypnosis

  • No intervention
    Wait-List Control

    Participants in this arm will continue their usual care for fatigue. The therapist will notify participants assigned to Usual Care via the participant's preferred mode of communication (phone, U.S. mail, or email). People assigned to usual care will be encouraged to continue using the health care services available to them to address their fatigue. The study therapist will emphasize the importance of completing the outcome assessments. Following the completion of their final assessment (3 month follow-up); these individuals will be offered their choice of the two hypnosis treatments.

Interventions

  • BehavioralActive-Alert Hypnosis

    Participants in this arm will receive four one-hour weekly sessions that will include training in a rapid self-hypnosis method. Participants will learn how to use waking hypnosis to manage fatigue using exercises with sensory experiences.

  • BehavioralTraditional Hypnosis

    Participants in this arm will receive four one-hour weekly sessions where participants will learn how to use hypnosis along with relaxation. The exercises and suggestions included in the training will be adapted from the protocol used in a series of studies on the efficacy of self-hypnosis training for the management of chronic pain in persons with disabilities, and from a therapist guide of procedures and hypnotic suggestions for chronic pain.

06

What researchers measure

Primary outcomes

  1. Fatigue Self Efficacy

    Multiple Sclerosis-Fatigue Self-Efficacy scale

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

  2. Fatigue Self Efficacy

    Multiple Sclerosis-Fatigue Self-Efficacy scale

    Time frame: Third week: mid-treatment (after second session)

  3. Fatigue Self Efficacy

    Multiple Sclerosis-Fatigue Self-Efficacy scale

    Time frame: Fifth week: post-treatment (after fourth session)

  4. Fatigue Self Efficacy

    Multiple Sclerosis-Fatigue Self-Efficacy scale

    Time frame: 4 months: 3 month follow-up

  5. Fatigue Severity

    Fatigue Severity Scale (FSS) score

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

  6. Fatigue Severity

    Fatigue Severity Scale (FSS) score

    Time frame: Third week: mid-treatment (after second session)

  7. Fatigue Severity

    Fatigue Severity Scale (FSS) score

    Time frame: Fifth week: post-treatment (after fourth session)

  8. Fatigue Severity

    Fatigue Severity Scale (FSS) score

    Time frame: 4 months: 3 month follow-up

Secondary outcomes

  1. Psychological and Physical Function

    PROMIS Physical Function SF score

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

  2. Psychological and Physical Function

    PROMIS Physical Function SF score

    Time frame: Third week: mid-treatment (after second session)

  3. Psychological and Physical Function

    PROMIS Physical Function SF score

    Time frame: Fifth week: post-treatment (after fourth session)

  4. Psychological and Physical Function

    PROMIS Physical Function SF score

    Time frame: 4 months: 3 month follow-up

  5. Activity Level

    IPAQ: International Physical Activity Questionnaire SF score

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

  6. Activity Level

    IPAQ: International Physical Activity Questionnaire SF score

    Time frame: Third week: mid-treatment (after second session)

  7. Activity Level

    IPAQ: International Physical Activity Questionnaire SF score

    Time frame: Fifth week: post-treatment (after fourth session)

  8. Activity Level

    IPAQ: International Physical Activity Questionnaire SF score

    Time frame: 4 months: 3 month follow-up

  9. Suggestibility

    Barber Suggestibility Scale score

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

  10. Suggestibility

    Barber Suggestibility Scale score

    Time frame: Fifth week: post-treatment (after fourth session)

  11. Attitudes towards hypnosis

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

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

  12. Attitudes towards hypnosis

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

    Time frame: Third week: mid-treatment (after second session)

  13. Attitudes towards hypnosis

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

    Time frame: Fifth week: post-treatment (after fourth session)

  14. Attitudes towards hypnosis

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

    Time frame: 4 months: 3 month follow-up

  15. Treatment Outcome Expectancy

    Treatment Expectancy Scale

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

  16. Sleep Quality

    PROMIS-SLEEP DISTURBANCE - SF 8A

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

  17. Sleep Quality

    PROMIS-SLEEP DISTURBANCE - SF 8A

    Time frame: Third week: mid-treatment (after second session)

  18. Sleep Quality

    PROMIS-SLEEP DISTURBANCE - SF 8A

    Time frame: Fifth week: post-treatment (after fourth session)

  19. Sleep Quality

    PROMIS-SLEEP DISTURBANCE - SF 8A

    Time frame: 4 months: 3 month follow-up

  20. Illness Perception

    Illness Perception Questionnaire

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

  21. Illness Perception

    Illness Perception Questionnaire

    Time frame: Third week: mid-treatment (after second session)

  22. Illness Perception

    Illness Perception Questionnaire

    Time frame: Fifth week: post-treatment (after fourth session)

  23. Illness Perception

    Illness Perception Questionnaire

    Time frame: 4 months: 3 month follow-up

Other outcomes

  1. Medication use for Fatigue

    CO-VARIATE - Medication self-report

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

  2. Medication use for Fatigue

    CO-VARIATE - Medication self-report

    Time frame: Third week: mid-treatment (after second session)

  3. Medication use for Fatigue

    CO-VARIATE - Medication self-report

    Time frame: Fifth week: post-treatment (after fourth session)

  4. Medication use for Fatigue

    CO-VARIATE - Medication self-report

    Time frame: 4 months: 3 month follow-up

07

Study locations

1 site
  • University of Washington
    Seattle, Washington 98104, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04429789
Lead sponsor
University of Washington
Collaborators
National Multiple Sclerosis Society
Responsible party
M. Elena Mendoza (Principal Investigator, University of Washington) — Principal investigator
First posted
Jun 12, 2020
Start date
May 27, 2020
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
May 3, 2021

Study contacts

M. Elena Mendoza, PhD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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