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

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: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Active-Alert Hypnosis; Behavioral: Traditional Hypnosis

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: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Third week: mid-treatment (after second session)
Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Fifth week: post-treatment (after fourth session)
Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	4 months: 3 month follow-up
Fatigue Severity	Fatigue Severity Scale (FSS) score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Fatigue Severity	Fatigue Severity Scale (FSS) score	Third week: mid-treatment (after second session)
Fatigue Severity	Fatigue Severity Scale (FSS) score	Fifth week: post-treatment (after fourth session)
Fatigue Severity	Fatigue Severity Scale (FSS) score	4 months: 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological and Physical Function	PROMIS Physical Function SF score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Psychological and Physical Function	PROMIS Physical Function SF score	Third week: mid-treatment (after second session)
Psychological and Physical Function	PROMIS Physical Function SF score	Fifth week: post-treatment (after fourth session)
Psychological and Physical Function	PROMIS Physical Function SF score	4 months: 3 month follow-up
Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Third week: mid-treatment (after second session)
Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Fifth week: post-treatment (after fourth session)
Activity Level	IPAQ: International Physical Activity Questionnaire SF score	4 months: 3 month follow-up
Suggestibility	Barber Suggestibility Scale score	Within a 1-week period at baseline (prior to randomization)
Suggestibility	Barber Suggestibility Scale score	Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis	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	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	Third week: mid-treatment (after second session)
Attitudes towards hypnosis	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	Fifth week: post-treatment (after fourth session)
Attitudes towards hypnosis	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	4 months: 3 month follow-up
Treatment Outcome Expectancy	Treatment Expectancy Scale	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Third week: mid-treatment (after second session)
Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Fifth week: post-treatment (after fourth session)
Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	4 months: 3 month follow-up
Illness Perception	Illness Perception Questionnaire	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Illness Perception	Illness Perception Questionnaire	Third week: mid-treatment (after second session)
Illness Perception	Illness Perception Questionnaire	Fifth week: post-treatment (after fourth session)
Illness Perception	Illness Perception Questionnaire	4 months: 3 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication use for Fatigue	CO-VARIATE - Medication self-report	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Medication use for Fatigue	CO-VARIATE - Medication self-report	Third week: mid-treatment (after second session)
Medication use for Fatigue	CO-VARIATE - Medication self-report	Fifth week: post-treatment (after fourth session)
Medication use for Fatigue	CO-VARIATE - Medication self-report	4 months: 3 month follow-up

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Multiple Sclerosis Society
• Investigators: Principal Investigator: M. Elena Mendoza, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 27, 2020
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis
• Other Study ID 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