Waking Hypnosis in the Treatment of MS-related Fatigue (POWER-UP)

April 29, 2021 updated by: M. Elena Mendoza, University of Washington

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98104
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Active-Alert Hypnosis
Behavioral: Active-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.
EXPERIMENTAL: Traditional Hypnosis
Behavioral: Traditional 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fatigue Self Efficacy
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Self Efficacy
Time Frame: Third week: mid-treatment (after second session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Third week: mid-treatment (after second session)
Fatigue Self Efficacy
Time Frame: Fifth week: post-treatment (after fourth session)
Multiple Sclerosis-Fatigue Self-Efficacy scale
Fifth week: post-treatment (after fourth session)
Fatigue Self Efficacy
Time Frame: 4 months: 3 month follow-up
Multiple Sclerosis-Fatigue Self-Efficacy scale
4 months: 3 month follow-up
Fatigue Severity
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity Scale (FSS) score
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity
Time Frame: Third week: mid-treatment (after second session)
Fatigue Severity Scale (FSS) score
Third week: mid-treatment (after second session)
Fatigue Severity
Time Frame: Fifth week: post-treatment (after fourth session)
Fatigue Severity Scale (FSS) score
Fifth week: post-treatment (after fourth session)
Fatigue Severity
Time Frame: 4 months: 3 month follow-up
Fatigue Severity Scale (FSS) score
4 months: 3 month follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Psychological and Physical Function
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
PROMIS Physical Function SF score
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Psychological and Physical Function
Time Frame: Third week: mid-treatment (after second session)
PROMIS Physical Function SF score
Third week: mid-treatment (after second session)
Psychological and Physical Function
Time Frame: Fifth week: post-treatment (after fourth session)
PROMIS Physical Function SF score
Fifth week: post-treatment (after fourth session)
Psychological and Physical Function
Time Frame: 4 months: 3 month follow-up
PROMIS Physical Function SF score
4 months: 3 month follow-up
Activity Level
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
IPAQ: International Physical Activity Questionnaire SF score
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Activity Level
Time Frame: Third week: mid-treatment (after second session)
IPAQ: International Physical Activity Questionnaire SF score
Third week: mid-treatment (after second session)
Activity Level
Time Frame: Fifth week: post-treatment (after fourth session)
IPAQ: International Physical Activity Questionnaire SF score
Fifth week: post-treatment (after fourth session)
Activity Level
Time Frame: 4 months: 3 month follow-up
IPAQ: International Physical Activity Questionnaire SF score
4 months: 3 month follow-up
Suggestibility
Time Frame: Within a 1-week period at baseline (prior to randomization)
Barber Suggestibility Scale score
Within a 1-week period at baseline (prior to randomization)
Suggestibility
Time Frame: Fifth week: post-treatment (after fourth session)
Barber Suggestibility Scale score
Fifth week: post-treatment (after fourth session)
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
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Attitudes towards hypnosis
Time Frame: Third week: mid-treatment (after second session)
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Third week: mid-treatment (after second session)
Attitudes towards hypnosis
Time Frame: Fifth week: post-treatment (after fourth session)
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis
Time Frame: 4 months: 3 month follow-up
Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version
4 months: 3 month follow-up
Treatment Outcome Expectancy
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Treatment Expectancy Scale
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
PROMIS-SLEEP DISTURBANCE - SF 8A
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality
Time Frame: Third week: mid-treatment (after second session)
PROMIS-SLEEP DISTURBANCE - SF 8A
Third week: mid-treatment (after second session)
Sleep Quality
Time Frame: Fifth week: post-treatment (after fourth session)
PROMIS-SLEEP DISTURBANCE - SF 8A
Fifth week: post-treatment (after fourth session)
Sleep Quality
Time Frame: 4 months: 3 month follow-up
PROMIS-SLEEP DISTURBANCE - SF 8A
4 months: 3 month follow-up
Illness Perception
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception Questionnaire
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception
Time Frame: Third week: mid-treatment (after second session)
Illness Perception Questionnaire
Third week: mid-treatment (after second session)
Illness Perception
Time Frame: Fifth week: post-treatment (after fourth session)
Illness Perception Questionnaire
Fifth week: post-treatment (after fourth session)
Illness Perception
Time Frame: 4 months: 3 month follow-up
Illness Perception Questionnaire
4 months: 3 month follow-up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medication use for Fatigue
Time Frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)
CO-VARIATE - Medication self-report
Assessed via telephone within a 1-week period at baseline (prior to randomization)
Medication use for Fatigue
Time Frame: Third week: mid-treatment (after second session)
CO-VARIATE - Medication self-report
Third week: mid-treatment (after second session)
Medication use for Fatigue
Time Frame: Fifth week: post-treatment (after fourth session)
CO-VARIATE - Medication self-report
Fifth week: post-treatment (after fourth session)
Medication use for Fatigue
Time Frame: 4 months: 3 month follow-up
CO-VARIATE - Medication self-report
4 months: 3 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Washington

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Multiple Sclerosis Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: M. Elena Mendoza, PhD, University of Washington

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 27, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00007428
  • PP-1904-33857 (OTHER_GRANT: National Multiple Sclerosis Society)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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