MS Symptom Management Study

Summary

People with Multiple Sclerosis (MS) often have pain and/or fatigue. Unfortunately, available treatments provide inadequate relief for the majority of these individuals. There remains an urgent need for additional treatment options for MS-related symptoms. The purpose of this study is to see if alternative treatments that involve self-hypnosis training, neurofeedback training and/or mindfulness meditation training, or a combination of some of these treatments can help decrease pain and fatigue in people with MS. A subject must have a diagnosis of MS, have chronic pain and/or fatigue, and be at least 18 years old to participate, among other criteria.

Conditions

• Multiple Sclerosis
• Chronic Pain
• Fatigue

Interventions

BEHAVIORAL

Intervention #1

Intervention #1 consists of 11 treatment sessions over 6-12 weeks (1-2 sessions/week on average). Sessions 1-6 will involve neurofeedback training. During neurofeedback training, sensors will be placed on a subject's head and ears, and s/he will be able to hear sounds on a computer that correspond to his/her brainwaves. The subject will learn how to change his/her brainwaves by changing the sounds heard. Session 7 will be a face-to-face self-hypnosis session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In sessions 8-11, subjects will listen to an audio recording of a self-hypnosis training session. Subjects will complete one neurofeedback training session immediately before each of these four hypnosis sessions. A relaxation and hypnotic exercise will also be done during two of the 11 sessions.

BEHAVIORAL

Intervention #2

Intervention #2 consists of 11 treatment sessions over 6-12 weeks (1-2 sessions/week on average). Sessions 1-6 will involve mindfulness meditation training. During mindfulness training, subjects will be asked to focus their attention on an object of awareness, such as their breath. Subjects will then be asked to focus on their feelings/thoughts during the training. Session 7 will be a face-to-face self-hypnosis session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In sessions 8-11, subjects will listen to an audio recording of a self-hypnosis training session. Subjects will complete one mindfulness meditation training session immediately before each of these four hypnosis sessions. A relaxation and hypnotic exercise will be done during two of the 11 sessions. On three of the 11 sessions, research staff will also place sensors on a subject's head and ears to measure brainwaves.

BEHAVIORAL

Intervention #3

Intervention #3 consists of five treatment sessions of self-hypnosis training during the treatment phase of the study (1-2 sessions/week on average). The treatment phase of the study will last about 6-12 weeks. During the first 4-5 weeks, subjects in Intervention #3 will not be asked by study researchers to do anything. At the end of this waiting period, subjects will complete a set of telephone interviews. Subjects will then attend one face-to-face self-hypnosis training session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In the last four sessions, subjects will listen to an audio recording of a self-hypnosis training session. A relaxation and hypnotic exercise will also be done during two of the five sessions.

Sponsors & Collaborators

• National Multiple Sclerosis Society

  collaborator OTHER

• University of Washington

  lead OTHER

Principal Investigators

• Mark Jensen, Ph.D. · University of Washington

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2016-11-30

Completion

2016-11-30

Countries

• United States

Study Locations