MS Symptom Management Study
MS Symptom Management Study
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.
Individuals from the study's recruitment sources with an MS diagnosis will be contacted by
 research staff via telephone and invited to be screened for participation. In addition,
 individuals interested in participating may contact research staff upon learning about the
 study through a description listed on an approved website, flyer, or a referral. Research
 staff will use a recruitment script for purposes of screening subjects and explaining the
 study. In addition, the initial screening process will also include a 6-item cognitive
 screening and a psychological screening assessment done by a licensed clinician.

 Research staff will verify the MS diagnosis of prospective subjects who have not been
 'pre-verified' in one of three ways during the recruitment process:

 1. Research staff will attempt to determine whether a subject has a University of
 Washington Medical Center (UWMC) or Harborview Medical Center (HMC) medical record by
 conducting a simple search using a secure application.

 If research staff are unable to locate a medical record for the prospective subject, or
 if the individual contacts research staff after seeing the study description on an
 approved website or flyer, then one of two options will be pursued:

 2. Subjects will be asked during the initial screening process if staff may review their
 medical records if they have received services at the UWMC/HMC since their diagnosis;

 3. Subjects will be asked during the initial screening process if staff may contact a
 physician of their choice to verify their diagnosis if (a) they have not received
 services at the UWMC/HMC since their diagnosis; (b) they refuse to give staff permission
 to review their UWMC/HMC medical records; or (c) staff for some reason cannot find a
 UWMC/HMC medical record despite the subject attesting to being a patient at one time at
 the UWMC/HMC and giving staff permission to review his/her records.

 Only individuals whose diagnosis has been verified (either via medical record review prior
 to/during screening or through verification via the subject's physician depending on
 recruitment source) will proceed with the psychological screening assessment.

 Once a prospective subject has been screened as eligible and gotten their MS diagnosis
 verified, research staff will arrange a time and date for the prospective subject to
 participate in a telephone psychological screening assessment with one of the study's
 licensed clinicians. The study clinician will ask potential subjects some questions to assess
 the presence of active suicidal ideation or paranoid thoughts using an assessment sheet.
 Individuals who do have these types of thoughts will not be eligible for the study.
 Individuals will be referred to a mental health professional if he or she needs immediate
 attention.

 Research staff will then arrange a time with the subject to attend an in-person initial
 intake session. At the beginning of the initial intake session, research staff will review a
 consent form with the subject and answer any questions he/she may have. The subject will
 complete and sign the consent form if he/she would like to participate. If the subject
 decides to enroll in the study, he/she will then be asked to participate in a relaxation and
 hypnotic exercise, and provide basic demographic and contact information, as well as
 information about their MS diagnosis and pain and/or fatigue problem(s) he/she experiences.
 The initial intake session will last about 1.5 hours depending on the subject's answers.

 Subjects will be randomly assigned (by chance, like flipping a coin) to one of three
 treatment interventions. All three treatment interventions involve learning self-hypnosis
 techniques. During self-hypnosis, subjects learn to enter a state of focused attention, and
 then change how they experience pain and/or fatigue. Two of the three treatment interventions
 will also include mindfulness meditation or neurofeedback training. Investigators are
 interested in comparing the three different approaches to treating chronic pain and/or
 fatigue.

 A research staff member will also contact each subject four times by telephone during his/her
 participation in the study to complete three short interviews or assessments, 3-5 minutes
 long, and one longer assessment, about 30-40 minutes long, in a period of one week. These
 assessments will be completed one week prior to the treatment period, about halfway through
 the treatment period, after the completion of treatment, and 1-month after the subject
 completes treatment. The three shorter assessments will include questions about pain
 intensity. The fourth longer assessment will include questions about such things as how the
 subject thinks about pain and fatigue, treatments for pain and/or fatigue the subject has
 received, medications or drugs the subject has used, and any depressive symptoms the subject
 may have experienced.
Inclusion Criteria:

 -  18 years of age or older

 -  Diagnosis of MS

 -  Moderate to severe chronic pain and/or fatigue

 -  Able to read, speak, and understand English

 Exclusion Criteria:

 -  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