Waking Hypnosis in the Treatment of MS-related Fatigue

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2021-03-31

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.

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Research assistant administering the telephone assessments is blinded to participant treatment intervention while the clinician conducting the treatment sessions is blinded to participant responses provided during telephone assessments. The only instance where we may unblind staff members to assessment or treatment data (depending on what the staff member is responsible for) will be at the end of the study, after data collection has been completed. At that point, the staff member conducting telephone assessments may be allowed to know which interventions participants were assigned to, and the clinician conducting treatment sessions may be allowed to access assessment data if a staff member were to assist in data cleaning or data analysis. Participants are blind to study hypotheses and will not be told which intervention is expected to yield what results. Participants may be unblinded if/when we disseminate findings (e.g., in a published manuscript) related to this study.

Study Groups

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Active-Alert Hypnosis

Group Type EXPERIMENTAL

Active-Alert Hypnosis

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Traditional Hypnosis

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No