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

University of Washington

Status: Completed

Conditions: Multiple Sclerosis; Fatigue

Treatments: Behavioral: Mindfulness Meditation (MM); Behavioral: Self-Hypnosis (HYP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04688710

STUDY00011189

RG-2001-36025 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 333 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Self-reported diagnosis of MS.
2. Age 18 years old or older at the time of study enrollment.
3. Presenting with clinically meaningful fatigue (i.e., reporting daily fatigue ≥50% of the days in the past 6 months with an average severity in the past week of ≥ 20 on the PROMIS Fatigue short form [T-score, 56.4]).
4. Able to read, speak, and understand English.
5. Access to an internet-enabled device (desktop/laptop/tablet/smart phone) to allow access to the recordings and to complete the study measures via the internet.

Exclusion criteria

1. Psychiatric condition or symptoms that would interfere with participation, specifically (a) current active suicidal ideation with current intent to harm oneself, (b) current psychosis, or (c) current mania.
2. Currently receiving psychological treatment for fatigue more than once per month.
3. Has received mindfulness meditation or hypnosis training in the past and has practiced mindfulness meditation/hypnosis in the past three months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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333 participants in 3 patient groups

Self-Hypnosis (HYP)

Active Comparator group

Description:

Participants receive an instructional manual and instructional audio recording to explain the study treatment and how to use audio recordings. Participants then receive a set of audio recordings once per week for 4 weeks teaching Self-Hypnosis. Following the 4 weeks of training to use treatment recordings, you will have 6 months of access to the recordings. Participants may access the recordings to use when convenient and are encouraged to access recordings daily for practice.

Treatment:

Behavioral: Self-Hypnosis (HYP)

Mindfulness Meditation (MM)

Active Comparator group

Description:

Participants receive an instructional manual and instructional audio recording to explain the study treatment and how to use audio recordings. Participants then receive a set of audio recordings once per week for 4 weeks teaching Mindfulness Meditation. Following the 4 weeks of training to use treatment recordings, you will have 6 months of access to the recordings. Participants may access the recordings to use when convenient and are encouraged to access recordings daily for practice.

Treatment:

Behavioral: Mindfulness Meditation (MM)

Treatment as Usual (TAU)

No Intervention group

Description:

Participants will not receive treatment from the study during the treatment phase. Participants will continue to receive their normal care outside of the study for MS and fatigue. Participants will have the option to access either the Self-Hypnosis or Mindfulness Meditation treatment after all study assessments have been completed.