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Self-Hypnosis + Mindfulness Meditation for Fatigue in MS (AUDIO Trial)

N/A

Waitlist Available

Led By Mark Jensen, Ph.D.

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years old or older at the time of study enrollment

Self-reported diagnosis of MS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4 (post-treatment), week 12 (3 month follow-up), week 24 (6-month follow-up)

Awards & highlights

AUDIO Trial Summary

This trial will compare two self-guided psychological treatments to usual care for people with MS who have clinically significant fatigue.

Who is the study for?

This trial is for adults over 18 with a self-reported diagnosis of MS who experience significant fatigue daily. Participants must speak English and have internet access to use the treatment recordings. Those with certain psychiatric conditions, frequent psychological treatments for fatigue, or recent mindfulness meditation/hypnosis training are excluded.Check my eligibility

What is being tested?

The study compares two self-guided treatments: Self-Hypnosis (HYP) and Mindfulness Meditation (MM), against usual care in managing fatigue in people with multiple sclerosis. The effectiveness of these psychological interventions will be measured and compared.See study design

What are the potential side effects?

Since HYP and MM are non-invasive psychological strategies focusing on relaxation and mental exercises, they typically do not cause physical side effects. However, some individuals might experience emotional discomfort or increased awareness of distressing thoughts during practice.

AUDIO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with multiple sclerosis.

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I have been feeling very tired most days for the last 6 months.

AUDIO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4 (post-treatment), week 12 (3 month follow-up), week 24 (6-month follow-up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4 (post-treatment), week 12 (3 month follow-up), week 24 (6-month follow-up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 (post-treatment), week 12 (3 month follow-up), week 24 (6-month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Fatigue Severity

Secondary outcome measures

Barriers and Facilitators to Treatment

Anxiety

Change in Depressive Symptoms

+9 more

Other outcome measures

Change in Fatigue Catastrophizing

Change in Mindfulness

Catastrophization

+7 more

AUDIO Trial Design

3Treatment groups

Active Control

Group I: Self-Hypnosis (HYP)Active Control1 Intervention

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.

Group II: Mindfulness Meditation (MM)Active Control1 Intervention

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.

Group III: Treatment as Usual (TAU)Active Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor

1,739 Previous Clinical Trials

1,847,609 Total Patients Enrolled

23 Trials studying Multiple Sclerosis

3,313 Patients Enrolled for Multiple Sclerosis

National Multiple Sclerosis SocietyOTHER

95 Previous Clinical Trials

9,150 Total Patients Enrolled

93 Trials studying Multiple Sclerosis

8,796 Patients Enrolled for Multiple Sclerosis

The University of QueenslandOTHER

140 Previous Clinical Trials

65,883 Total Patients Enrolled

Media Library

Mindfulness Meditation Clinical Trial Eligibility Overview. Trial Name: NCT04688710 — N/A

Multiple Sclerosis Research Study Groups: Self-Hypnosis (HYP), Mindfulness Meditation (MM), Treatment as Usual (TAU)

Multiple Sclerosis Clinical Trial 2023: Mindfulness Meditation Highlights & Side Effects. Trial Name: NCT04688710 — N/A

Mindfulness Meditation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04688710 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled for this research project?

"Affirmative. Clinicaltrials.gov reveals that this research project, which was initially posted on April 30th 2021, is currently looking for participants to take part in the trial. Currently 333 individuals are needed at one medical centre."

Answered by AI

Is enrollment into this scientific experiment still open?

"Affirmative - the trial's listing on clinicaltrials.gov states that recruitment of patients is presently ongoing, beginning with its posting in April 2021 and most recently updated at the end of August 2022. This research project seeks to add 333 participants from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mark Jensen 2021. "Use of Audio Recordings of Self-Hypnosis and Meditation for Fatigue Management in Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04688710.