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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
333
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.
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.
UW Medicine Multiple Sclerosis Center
Seattle, Washington, United States
Change in Fatigue Severity
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Sleep Quality assessed via PROMIS Sleep Disturbance Short Form 4a, version 1.0
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Pain Interference
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Pain Intensity and Fatigue (current)
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.
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Time frame: Immediately before and after listening to treatment audio recordings
Change in Pain Intensity (past week)
Change in pain intensity in the past week will be measured using a 0-10 numeric rating scale.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Depressive Symptoms
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Anxiety
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Physical Function
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.
Time frame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Treatment Preference
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.
Time frame: Baseline (prior to treatment)
Device Use for Treatment
Type of device(s) used to access treatment recordings will be assessed by participant self-report.
Time frame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Global Impression of Change
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).
Time frame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Change in Global Assessment of Treatment Satisfaction
Global assessment of treatment satisfaction will be measured by participant self-report on a scale of 0 (very dissatisfied) - 4 (very satisfied).
Time frame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Barriers and Facilitators to Treatment
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.
Time frame: Week 12 (3 month follow-up), Week 24 (6-month follow-up)