University of Washington
Seattle, Washington, 98104, United States
NCT Number: NCT04429789
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Time frame: Third week: mid-treatment (after second session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Time frame: Fifth week: post-treatment (after fourth session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Time frame: 4 months: 3 month follow-up
Multiple Sclerosis-Fatigue Self-Efficacy scale
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity Scale (FSS) score
Time frame: Third week: mid-treatment (after second session)
Fatigue Severity Scale (FSS) score
Time frame: Fifth week: post-treatment (after fourth session)
Fatigue Severity Scale (FSS) score
Time frame: 4 months: 3 month follow-up
Fatigue Severity Scale (FSS) score
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
PROMIS Physical Function SF score
Time frame: Third week: mid-treatment (after second session)
PROMIS Physical Function SF score
Time frame: Fifth week: post-treatment (after fourth session)
PROMIS Physical Function SF score
Time frame: 4 months: 3 month follow-up
PROMIS Physical Function SF score
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
IPAQ: International Physical Activity Questionnaire SF score
Time frame: Third week: mid-treatment (after second session)
IPAQ: International Physical Activity Questionnaire SF score
Time frame: Fifth week: post-treatment (after fourth session)
IPAQ: International Physical Activity Questionnaire SF score
Time frame: 4 months: 3 month follow-up
IPAQ: International Physical Activity Questionnaire SF score
Time frame: Within a 1-week period at baseline (prior to randomization)
Barber Suggestibility Scale score
Time frame: Fifth week: post-treatment (after fourth session)
Barber Suggestibility Scale score
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
Time frame: Third week: mid-treatment (after second session)
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Time frame: Fifth week: post-treatment (after fourth session)
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Time frame: 4 months: 3 month follow-up
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)
Treatment Expectancy Scale
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
PROMIS-SLEEP DISTURBANCE - SF 8A
Time frame: Third week: mid-treatment (after second session)
PROMIS-SLEEP DISTURBANCE - SF 8A
Time frame: Fifth week: post-treatment (after fourth session)
PROMIS-SLEEP DISTURBANCE - SF 8A
Time frame: 4 months: 3 month follow-up
PROMIS-SLEEP DISTURBANCE - SF 8A
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception Questionnaire
Time frame: Third week: mid-treatment (after second session)
Illness Perception Questionnaire
Time frame: Fifth week: post-treatment (after fourth session)
Illness Perception Questionnaire
Time frame: 4 months: 3 month follow-up
Illness Perception Questionnaire
Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
CO-VARIATE - Medication self-report
Time frame: Third week: mid-treatment (after second session)
CO-VARIATE - Medication self-report
Time frame: Fifth week: post-treatment (after fourth session)
CO-VARIATE - Medication self-report
Time frame: 4 months: 3 month follow-up
CO-VARIATE - Medication self-report
University of Washington
Other
Waking Hypnosis in the Treatment of MS-related Fatigue: Pilot and Feasibility Study
Acronym: POWER-UP
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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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