Waking Hypnosis in the Treatment of MS-related Fatigue

University of Washington32 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Active-Alert HypnosisBEHAVIORAL

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 HypnosisBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Washington

Seattle, Washington, United States

Outcomes

Primary Outcomes

Fatigue Self Efficacy

Multiple Sclerosis-Fatigue Self-Efficacy scale

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Fatigue Self Efficacy

Multiple Sclerosis-Fatigue Self-Efficacy scale

Time frame: Third week: mid-treatment (after second session)

Fatigue Self Efficacy

Multiple Sclerosis-Fatigue Self-Efficacy scale

Time frame: Fifth week: post-treatment (after fourth session)

Fatigue Self Efficacy

Multiple Sclerosis-Fatigue Self-Efficacy scale

Time frame: 4 months: 3 month follow-up

Fatigue Severity

Fatigue Severity Scale (FSS) score

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Fatigue Severity

Fatigue Severity Scale (FSS) score

Time frame: Third week: mid-treatment (after second session)

Fatigue Severity

Fatigue Severity Scale (FSS) score

Time frame: Fifth week: post-treatment (after fourth session)

Fatigue Severity

Fatigue Severity Scale (FSS) score

Time frame: 4 months: 3 month follow-up

Secondary Outcomes

Data from ClinicalTrials.gov

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Psychological and Physical Function

PROMIS Physical Function SF score

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Psychological and Physical Function

PROMIS Physical Function SF score

Time frame: Third week: mid-treatment (after second session)

Psychological and Physical Function

PROMIS Physical Function SF score

Time frame: Fifth week: post-treatment (after fourth session)

Psychological and Physical Function

PROMIS Physical Function SF score

Time frame: 4 months: 3 month follow-up

Activity Level

IPAQ: International Physical Activity Questionnaire SF score

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Activity Level

IPAQ: International Physical Activity Questionnaire SF score

Time frame: Third week: mid-treatment (after second session)

Activity Level

IPAQ: International Physical Activity Questionnaire SF score

Time frame: Fifth week: post-treatment (after fourth session)

Activity Level

IPAQ: International Physical Activity Questionnaire SF score

Time frame: 4 months: 3 month follow-up

Suggestibility

Barber Suggestibility Scale score

Time frame: Within a 1-week period at baseline (prior to randomization)

Suggestibility

Barber Suggestibility Scale score

Time frame: Fifth week: post-treatment (after fourth session)

Attitudes towards hypnosis

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)

Attitudes towards hypnosis

Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

Time frame: Third week: mid-treatment (after second session)

Attitudes towards hypnosis

Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

Time frame: Fifth week: post-treatment (after fourth session)

Attitudes towards hypnosis

Valencia Scale of Attitudes and Beliefs toward Hypnosis -Client version

Time frame: 4 months: 3 month follow-up

Treatment Outcome Expectancy

Treatment Expectancy Scale

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Sleep Quality

PROMIS-SLEEP DISTURBANCE - SF 8A

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Sleep Quality

PROMIS-SLEEP DISTURBANCE - SF 8A

Time frame: Third week: mid-treatment (after second session)

Sleep Quality

PROMIS-SLEEP DISTURBANCE - SF 8A

Time frame: Fifth week: post-treatment (after fourth session)

Sleep Quality

PROMIS-SLEEP DISTURBANCE - SF 8A

Time frame: 4 months: 3 month follow-up

Illness Perception

Illness Perception Questionnaire

Time frame: Assessed via telephone within a 1-week period at baseline (prior to randomization)

Illness Perception

Illness Perception Questionnaire

Time frame: Third week: mid-treatment (after second session)

Illness Perception

Illness Perception Questionnaire

Time frame: Fifth week: post-treatment (after fourth session)

Illness Perception

Illness Perception Questionnaire

Time frame: 4 months: 3 month follow-up