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

NCT04688710 | Completed

• 2 other identifiers: STUDY00011189RG-2001-36025
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Fatigue

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

Secondary Outcomes (12)

• 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 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 Intensity and Fatigue (current)

  Immediately before and after listening to treatment audio recordings

• 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 Depressive Symptoms

  Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

Other Outcomes (10)

• Medication and/or Cannabis Use

  Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

• Frequency and Duration of Listening to Treatment Audio Recordings

  Each time treatment recordings are accessed from Week 1 through Week 24

• Change in Fatigue Catastrophizing

  Baseline (prior to treatment), Week 4 (post-treatment), Week 12 (3 month follow-up), Week 24 (6-month follow-up)

Study Arms (3)

Self-Hypnosis (HYP)

ACTIVE COMPARATOR

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.

Behavioral: Self-Hypnosis (HYP)

Mindfulness Meditation (MM)

ACTIVE COMPARATOR

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.

Behavioral: Mindfulness Meditation (MM)

Treatment as Usual (TAU)

NO INTERVENTION

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.

Interventions

Self-Hypnosis (HYP) BEHAVIORAL

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.

Self-Hypnosis (HYP)

Mindfulness Meditation (MM) BEHAVIORAL

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.

Mindfulness Meditation (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported diagnosis of MS.
• Age 18 years old or older at the time of study enrollment.
• 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 \[T-score, 56.4\]).
• Able to read, speak, and understand English.
• 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.

You may not qualify if:

• 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.
• Currently receiving psychological treatment for fatigue more than once per month.
• Has received mindfulness meditation or hypnosis training in the past and has practiced mindfulness meditation/hypnosis in the past three months.

Sponsors & Collaborators

• University of Washington: lead
• National Multiple Sclerosis Society: collaborator
• The University of Queensland: collaborator

Study Sites (1)

UW Medicine Multiple Sclerosis Center

Seattle, Washington, 98133, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue

Interventions

Hypnosis; Mindfulness

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Behavior Therapy

Study Officials

• Mark Jensen, Ph.D.

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Model Details: 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

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 30, 2020
• Study Start: April 30, 2021
• Primary Completion: June 27, 2023
• Study Completion: December 31, 2023
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to Dr. Mark Jensen (mjensen@uw.edu). To gain access, requestors will need to sign a data access agreement. Data will be provided via a HIPAA-compliant file sharing system.

Locations

US (1)