MS Symptom Management Study

NCT02474940 | Completed

• 2 other identifiers: 46765-EBRG 5232-A-4
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multiple Sclerosis; Chronic Pain; Chronic Fatigue; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Central Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases

Outcome Measures

Primary Outcomes (2)

• Change in average pain intensity pre-treatment to post-treatment

  Average pain intensity will be assessed via telephone interviews using a 0-10 numerical rating scale (NRS) of average pain in the past 24 hours, four times within a 1-week period at each assessment point.

  Pre-treatment (1 week before Session 1), Mid-treatment (1 week before Session 7), Post-treatment (within a week after Session 11), 1-month following end of treatment

• Change in average fatigue severity pre-treatment to post-treatment

  Fatigue severity will be assessed with the Fatigue Severity Scale (FSS). The 9-item FSS asks respondents to rate fatigue and the extent to which it interferes with activities on 1 (Strongly disagree) to 7 (Strongly agree) scales. The FSS is assessed once at each assessment point.

  Pre-treatment (1 week before Session 1), Mid-treatment (1 week before Session 7), Post-treatment (within a week after Session 11), 1-month following end of treatment

Study Arms (3)

Intervention #1

EXPERIMENTAL

NF-HYP

Behavioral: Intervention #1

Intervention #2

EXPERIMENTAL

MM-HYP

Behavioral: Intervention #2

Intervention #3

EXPERIMENTAL

HYP-ONLY

Behavioral: Intervention #3

Interventions

Intervention #1 BEHAVIORAL

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.

Intervention #1

Intervention #2 BEHAVIORAL

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.

Intervention #2

Intervention #3 BEHAVIORAL

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.

Intervention #3

Eligibility Criteria

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

You may qualify if:

• years of age or older
• Diagnosis of MS
• Moderate to severe chronic pain and/or fatigue
• Able to read, speak, and understand English

You may not qualify if:

• Severe cognitive impairment defined as two or more errors on the Six-Item Screener
• History of seizure activity
• Psychiatric condition or symptoms that would interfere with participation
• Currently receiving psychological treatment for pain and/or fatigue
• Has participated in any previous or current research study conducted by investigators in the Department of Rehabilitation Medicine that involved pain or fatigue management via psychological treatments

Sponsors & Collaborators

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

Study Sites (1)

University of Washington, Ninth and Jefferson Building

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain; Fatigue; Autoimmune Diseases; Autoimmune Diseases of the Nervous System; Central Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases

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

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 18, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)