Clinical trial NCT04688710: Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis
Official title: Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: The University of Queensland
First posted: 2020-12-30
Enrollment: 333
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, 3-group parallel design, 333-subject clinical trial to test the efficacy of Self-Hypnosis (HYP) and Mindfulness Meditation (MM) compared to Treatment as Usual (TAU) for individuals with multiple sclerosis and clinically significant fatigue
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Fatigue Severity
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Secondary outcomes:
measure: Change in Sleep Quality assessed via PROMIS Sleep Disturbance Short Form 4a, version 1.0
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Pain Interference
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Pain Intensity and Fatigue (current)
timeFrame: Immediately before and after listening to treatment audio recordings
measure: Change in Pain Intensity (past week)
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Depressive Symptoms
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Anxiety
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Physical Function
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Treatment Preference
timeFrame: Baseline (prior to treatment)
measure: Device Use for Treatment
timeFrame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Global Impression of Change
timeFrame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Global Assessment of Treatment Satisfaction
timeFrame: Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Barriers and Facilitators to Treatment
timeFrame: Week 12 (3 month follow-up), Week 24 (6-month follow-up)
Other outcomes:
measure: Medication and/or Cannabis Use
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Frequency and Duration of Listening to Treatment Audio Recordings
timeFrame: Each time treatment recordings are accessed from Week 1 through Week 24
measure: Change in Fatigue Catastrophizing
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Pain Type
timeFrame: Baseline (prior to treatment)
measure: Change in Pain Catastrophizing
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Readiness to Engage in Pain Self-Management
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Pain-Related Cognitive Processes
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Satisfaction with Life assessed via the Satisfaction with Life Scale (SWLS)
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Change in Mindfulness
timeFrame: Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)
measure: Outcome Expectancy
timeFrame: Baseline (prior to treatment)
Locations:
city: Seattle
country: United States
facility: UW Medicine Multiple Sclerosis Center
state: Washington
Study officials:
affiliation: University of Washington
name: Mark Jensen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: