Waking Hypnosis in the Treatment of MS-related Fatigue

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Behavioral: Traditional Hypnosis; Behavioral: Active-Alert Hypnosis

• Registration Number: NCT04429789
• Lead Sponsor: University of Washington

Brief 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.

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 Timeline

• Study First Submitted: 2020-05-11
• Study Start: 2020-05-27
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-12
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-29
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Hypnosis	Traditional Hypnosis	-
Active-Alert Hypnosis	Active-Alert Hypnosis	-

Primary Outcome Measures

Name	Time	Method
Fatigue Self Efficacy	4 months: 3 month follow-up	Multiple Sclerosis-Fatigue Self-Efficacy scale
Fatigue Severity	4 months: 3 month follow-up	Fatigue Severity Scale (FSS) score

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States