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

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Fatigue
• Interventions: Behavioral: Mindfulness Meditation (MM); Behavioral: Self-Hypnosis (HYP)

• Registration Number: NCT04688710
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2020-12-23
• Study First Submitted QC: 2020-12-23
• Study First Posted: 2020-12-30
• Study Start: 2021-04-30
• Primary Completion: 2023-06-27
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation (MM)	Mindfulness Meditation (MM)	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.
Self-Hypnosis (HYP)	Self-Hypnosis (HYP)	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.

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Severity	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in fatigue severity will be measured using the Modified Fatigue Impact Scale (MFIS). The 21-item MFIS was selected as the measure of choice for assessing fatigue in MS populations by the MS Council for Clinical Practice Guidelines. The MFIS is also listed as one of the NIH NINDS' common data elements for MS. With the MFIS, respondents indicate the frequency with which they experience each fatigue-related outcome (e.g., forgetful, weak muscles) on a 5-point Likert scale (0 = Never; 4 = Almost always). The items can be scored into three subscales (reflecting cognitive, physical, and psychosocial fatigue impact) or a total fatigue severity score.

Secondary Outcome Measures

Name	Time	Method
Change in Global Assessment of Treatment Satisfaction	Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Global assessment of treatment satisfaction will be measured by participant self-report on a scale of 0 (very dissatisfied) - 4 (very satisfied).
Change in Sleep Quality assessed via PROMIS Sleep Disturbance Short Form 4a, version 1.0	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 4a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of sleep disturbance.
Change in Pain Interference	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in pain interference will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 4a, version 1.1. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of pain interference.
Change in Depressive Symptoms	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in depressive symptoms will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short Form 4a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of depressive symptoms.
Change in Physical Function	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 4a, version 2.0. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of physical functioning.
Change in Pain Intensity (past week)	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in pain intensity in the past week will be measured using a 0-10 numeric rating scale.
Change in Anxiety	Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Change in symptoms of anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 4a, version 1.0. Responses from each item will be summed to form a total raw score ranging from 4-20. Higher scores indicate higher self-reported levels of anxiety symptoms.
Change in Pain Intensity and Fatigue (current)	Immediately before and after listening to treatment audio recordings	Change in current pain intensity and fatigue will be measured using a 0-10 numeric rating scale immediately before and after listening to audio recordings.
Treatment Preference	Baseline (prior to treatment)	Participants' preferences for each of the three randomization groups will be measured at baseline (prior to treatment). Treatment preferences will be measured using a 0 (not at all interested) - 10 (extremely interested) numerical rating scale to gauge interest in each randomization group.
Device Use for Treatment	Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Type of device(s) used to access treatment recordings will be assessed by participant self-report.
Change in Global Impression of Change	Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Global impression of change will be measured by participant self-report. Participants will report, since the start of the study, how much they think their overall fatigue intensity, interference of fatigue in daily activities, and ability to manage fatigue has changed on a scale of 1 (very much improved) - 7 (very much worse).
Barriers and Facilitators to Treatment	Week 12 (3 month follow-up), Week 24 (6-month follow-up)	Barriers and facilitators to participants engaging in treatment will be assessed by qualitative open-ended questions asking what made it harder or easier for participants to listen to recordings, as well as what participants liked most and least about listening to recordings.

Trial Locations

Locations (1)

UW Medicine Multiple Sclerosis Center; 🇺🇸 Seattle, Washington, United States