Waking Hypnosis in the Treatment of MS-related Fatigue (POWER-UP)

University of Washington

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Traditional Hypnosis; Behavioral: Active-Alert Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04429789

PP-1904-33857 (Other Grant/Funding Number)

STUDY00007428

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 3 patient groups

Active-Alert Hypnosis

Experimental group

Treatment:

Behavioral: Active-Alert Hypnosis

Traditional Hypnosis

Experimental group

Treatment:

Behavioral: Traditional Hypnosis

Wait-List Control

No Intervention group

Description:

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.