NCT04688710

Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness of two self-guided psychological treatments, Self-Hypnosis (HYP) and Mindfulness Meditation (MM) compared to Treatment as Usual (TAU) for people with multiple sclerosis (MS) and clinically significant fatigue.

Detailed description

People with multiple sclerosis (MS) often have problems with fatigue that can interfere with other treatments. As many as 90% of individuals with MS experience persistent fatigue and 40% of individuals with MS describe fatigue as their most debilitating symptom. Fatigue in individuals with MS is also associated with greater distress and lower overall quality of life. Unfortunately, available treatments provide inadequate relief for most people. There remains an urgent need for additional treatment options for MS-related fatigue. The purpose of this study is to see if self-guided psychological treatments delivered through audio recordings can help decrease fatigue severity in people with MS. This study will evaluate the efficacy of two promising and innovative psychological treatments, Mindfulness Meditation (MM) and Self-Hypnosis (HYP), for helping individuals with MS manage fatigue. Since these treatments are self-guided, findings will provide evidence for the efficacy of highly accessible treatments, ultimately resulting in treatment interventions that can be easily disseminated without the need for highly trained specialist clinicians. Primary Aim: The primary aim of the proposed research is to evaluate the beneficial effects of two treatments (HYP and MM) for reducing MS-related fatigue, relative to Treatment as Usual (TAU). Primary Hypothesis (stated under the alternative): Participants assigned to HYP and MM conditions will report significantly greater reductions in fatigue at post-treatment, the primary end point, than those assigned to the TAU condition. The proposed research also has three secondary aims: Secondary Aim 1: To investigate whether there are beneficial effects of the two active treatments, relative to TAU, on pre- to post-treatment changes in secondary quality of life outcomes (e.g., sleep quality, pain intensity). Secondary Aim 2: To investigate whether there are longer-term benefits of the two active treatments, relative to each other and to TAU, on the primary and secondary outcomes, up to 6 months post-treatment. Exploratory Aim 3: To investigate whether there is participant preference for either of the two active treatments, and investigate their relative effects on the study outcomes in an "open label" effectiveness analysis.

Conditions

• Multiple Sclerosis
• Fatigue

Interventions

Type	Name	Description
BEHAVIORAL	Self-Hypnosis (HYP)	Self-Hypnosis (HYP) teaches skills people with MS can use to effectively self-manage symptoms related to fatigue. Recordings are designed to help participants learn new strategies for influencing fatigue and its effects on their lives. The Self-Hypnosis recordings will start with a relaxation hypnotic induction (e.g., "Notice how with each breath, you are feeling more and more relaxed …") followed by hypnotic suggestions (e.g., for experiencing more energy, improved sleep, more comfort or less pain, etc.). The goal of Self-Hypnosis is to change participant's experiences. To the extent that participants respond to the suggestions, participants would then get more control over their feelings of energy, sleep quality, and comfort levels.
BEHAVIORAL	Mindfulness Meditation (MM)	Mindfulness Meditation (MM) teaches skills people with MS can use to effectively self-manage symptoms related to fatigue. Recordings are designed to help participants learn about a new way to live with chronic fatigue and new ways to relate to how fatigue may influence their thoughts, feelings, and behavior. The mindfulness techniques train the mind to non-judgmentally observe experience (e.g., symptoms of fatigue or pain, etc.) on a moment-to-moment basis, with an attitude of acceptance. The goal of Mindfulness Meditation is not to alter experiences, but rather to change how someone responds to their experiences. With practice, automatic, kneejerk reactions to symptoms are replaced with mindful choices about how best to respond to symptoms. This will "lighten the load" of living with the symptoms, moving participants in the valued direction of their choosing.

Timeline

• Start date: 2021-04-30
• Primary completion: 2023-06-27
• Completion: 2023-12-31
• First posted: 2020-12-30
• Last updated: 2024-05-17

Locations

1 site across 1 country: United States