Waking Hypnosis in the Treatment of MS-related Fatigue

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Active-Alert Hypnosis
* Behavioral: Traditional Hypnosis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active-Alert Hypnosis<br> | Behavioral: Active-Alert Hypnosis<br>* 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.<br>|
| Experimental: Traditional Hypnosis<br> | Behavioral: Traditional Hypnosis<br>* 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.<br>|
| No Intervention: Wait-List Control<br>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?
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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 |