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Completed

NCT Number: NCT04429789

Waking Hypnosis in the Treatment of MS-related Fatigue

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active-Alert Hypnosis

Behavioral

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.

Traditional Hypnosis

Behavioral

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.

Primary outcomes

  1. Fatigue Self Efficacy

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

    Multiple Sclerosis-Fatigue Self-Efficacy scale

  2. Fatigue Self Efficacy

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

    Multiple Sclerosis-Fatigue Self-Efficacy scale

  3. Fatigue Self Efficacy

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

    Multiple Sclerosis-Fatigue Self-Efficacy scale

  4. Fatigue Self Efficacy

    Time frame: 4 months: 3 month follow-up

    Multiple Sclerosis-Fatigue Self-Efficacy scale

  5. Fatigue Severity

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

    Fatigue Severity Scale (FSS) score

  6. Fatigue Severity

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

    Fatigue Severity Scale (FSS) score

  7. Fatigue Severity

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

    Fatigue Severity Scale (FSS) score

  8. Fatigue Severity

    Time frame: 4 months: 3 month follow-up

    Fatigue Severity Scale (FSS) score

Secondary outcomes

  1. Psychological and Physical Function

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

    PROMIS Physical Function SF score

  2. Psychological and Physical Function

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

    PROMIS Physical Function SF score

  3. Psychological and Physical Function

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

    PROMIS Physical Function SF score

  4. Psychological and Physical Function

    Time frame: 4 months: 3 month follow-up

    PROMIS Physical Function SF score

  5. Activity Level

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

    IPAQ: International Physical Activity Questionnaire SF score

  6. Activity Level

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

    IPAQ: International Physical Activity Questionnaire SF score

  7. Activity Level

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

    IPAQ: International Physical Activity Questionnaire SF score

  8. Activity Level

    Time frame: 4 months: 3 month follow-up

    IPAQ: International Physical Activity Questionnaire SF score

  9. Suggestibility

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

    Barber Suggestibility Scale score

  10. Suggestibility

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

    Barber Suggestibility Scale score

  11. Attitudes towards hypnosis

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

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

  12. Attitudes towards hypnosis

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

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

  13. Attitudes towards hypnosis

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

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

  14. Attitudes towards hypnosis

    Time frame: 4 months: 3 month follow-up

    Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

  15. Treatment Outcome Expectancy

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

    Treatment Expectancy Scale

  16. Sleep Quality

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

    PROMIS-SLEEP DISTURBANCE - SF 8A

  17. Sleep Quality

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

    PROMIS-SLEEP DISTURBANCE - SF 8A

  18. Sleep Quality

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

    PROMIS-SLEEP DISTURBANCE - SF 8A

  19. Sleep Quality

    Time frame: 4 months: 3 month follow-up

    PROMIS-SLEEP DISTURBANCE - SF 8A

  20. Illness Perception

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

    Illness Perception Questionnaire

  21. Illness Perception

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

    Illness Perception Questionnaire

  22. Illness Perception

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

    Illness Perception Questionnaire

  23. Illness Perception

    Time frame: 4 months: 3 month follow-up

    Illness Perception Questionnaire

Other outcomes

  1. Medication use for Fatigue

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

    CO-VARIATE - Medication self-report

  2. Medication use for Fatigue

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

    CO-VARIATE - Medication self-report

  3. Medication use for Fatigue

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

    CO-VARIATE - Medication self-report

  4. Medication use for Fatigue

    Time frame: 4 months: 3 month follow-up

    CO-VARIATE - Medication self-report

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Multiple Sclerosis Society

Registry information

Official study title

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

Acronym: POWER-UP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 12, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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