Waking Hypnosis in the Treatment of MS-related Fatigue

Multiple Sclerosis Clinical Trial

— POWER-UP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04429789
• Other study ID #: STUDY00007428
• Secondary ID: PP-1904-33857
• Status: Completed
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Multiple Sclerosis Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication use for Fatigue	CO-VARIATE - Medication self-report	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Other	Medication use for Fatigue	CO-VARIATE - Medication self-report	Third week: mid-treatment (after second session)
Other	Medication use for Fatigue	CO-VARIATE - Medication self-report	Fifth week: post-treatment (after fourth session)
Other	Medication use for Fatigue	CO-VARIATE - Medication self-report	4 months: 3 month follow-up
Primary	Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Primary	Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Third week: mid-treatment (after second session)
Primary	Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	Fifth week: post-treatment (after fourth session)
Primary	Fatigue Self Efficacy	Multiple Sclerosis-Fatigue Self-Efficacy scale	4 months: 3 month follow-up
Primary	Fatigue Severity	Fatigue Severity Scale (FSS) score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Primary	Fatigue Severity	Fatigue Severity Scale (FSS) score	Third week: mid-treatment (after second session)
Primary	Fatigue Severity	Fatigue Severity Scale (FSS) score	Fifth week: post-treatment (after fourth session)
Primary	Fatigue Severity	Fatigue Severity Scale (FSS) score	4 months: 3 month follow-up
Secondary	Psychological and Physical Function	PROMIS Physical Function SF score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Secondary	Psychological and Physical Function	PROMIS Physical Function SF score	Third week: mid-treatment (after second session)
Secondary	Psychological and Physical Function	PROMIS Physical Function SF score	Fifth week: post-treatment (after fourth session)
Secondary	Psychological and Physical Function	PROMIS Physical Function SF score	4 months: 3 month follow-up
Secondary	Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Secondary	Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Third week: mid-treatment (after second session)
Secondary	Activity Level	IPAQ: International Physical Activity Questionnaire SF score	Fifth week: post-treatment (after fourth session)
Secondary	Activity Level	IPAQ: International Physical Activity Questionnaire SF score	4 months: 3 month follow-up
Secondary	Suggestibility	Barber Suggestibility Scale score	Within a 1-week period at baseline (prior to randomization)
Secondary	Suggestibility	Barber Suggestibility Scale score	Fifth week: post-treatment (after fourth session)
Secondary	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)
Secondary	Attitudes towards hypnosis	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	Third week: mid-treatment (after second session)
Secondary	Attitudes towards hypnosis	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	Fifth week: post-treatment (after fourth session)
Secondary	Attitudes towards hypnosis	Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version	4 months: 3 month follow-up
Secondary	Treatment Outcome Expectancy	Treatment Expectancy Scale	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Secondary	Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Secondary	Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Third week: mid-treatment (after second session)
Secondary	Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	Fifth week: post-treatment (after fourth session)
Secondary	Sleep Quality	PROMIS-SLEEP DISTURBANCE - SF 8A	4 months: 3 month follow-up
Secondary	Illness Perception	Illness Perception Questionnaire	Assessed via telephone within a 1-week period at baseline (prior to randomization)
Secondary	Illness Perception	Illness Perception Questionnaire	Third week: mid-treatment (after second session)
Secondary	Illness Perception	Illness Perception Questionnaire	Fifth week: post-treatment (after fourth session)
Secondary	Illness Perception	Illness Perception Questionnaire	4 months: 3 month follow-up