Power Over Pain (POP) Study
Power Over Pain (POP) Study
Many individuals with multiple sclerosis (MS), spinal cord injury (SCI), acquired amputation
 (AMP), muscular dystrophy (MD), and low back pain (LBP) experience pain. There has been
 little research on how to treat this pain. Different types of treatment that include
 self-hypnosis, education about chronic pain, and learning skills on how to change how a
 person thinks about his/her pain have been used to treat chronic pain in the general
 population. The purpose of this study is to see if these different treatments can help
 decrease pain in people with multiple sclerosis and spinal cord injury, and determine how and
 why these treatments are effective. A subject must have a diagnosis of MS,SCI, AMP, MD, or
 LBP, have chronic pain, and be at least 18 years old to participate.
Individuals from the study's recruitment sources with the diagnoses listed above 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 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 conducting a cognitive
 screening known as the 6-item cognitive screener.

 Research staff will verify the diagnoses (MS, SCI, AMP, MD or LBP) 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 from has a University of
 Washington Medical Center (UWMC)/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 from
 recruitment strategy #1, or if the individual is part of recruitment strategy #4 (i.e.
 if individual sees description of study on clinicaltrials.gov and contacts research
 staff), 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 and deemed eligible to participate, research
 staff will arrange a time and date for all subjects recruited into the study to participate
 in a telephone psychological screening assessment with one of the study's licensed clinicians
 (Drs. Jensen, Ehde, Molton, or Dillworth) or senior fellow (Elena Mendoza, a clinical
 psychologist). 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 in person what we call the
 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 complete a set of tasks testing
 memory and processing speed, participate in a relaxation and hypnotic exercise, and provide
 basic demographic information, as well as information about diagnosis and pain problem(s)
 he/she experiences. The initial intake session will last about 1.5 hours depending on the
 subject's answers.

 The subject will then participate in a brain activity assessment at the Integrated Brain
 Imaging Center (IBIC) at the University of Washington that will take about one hour to
 complete. The brain activity assessment consists of an electroencephalogram (EEG), which
 measures the electrical activity in the brain through electrodes placed on the scalp. There
 is no risk of electrical shock. Research staff will place a damp electrode net on the
 subject's head that contains the electrodes that will measure the subject's brain activity.
 EEG activity will be collected with the subject's eyes closed. The research staff member will
 collect the data and ask the subject to remain as still as possible during the assessment. A
 research staff member will ask the subject his/her pain intensity during and after the
 assessment.

 Subjects will be randomly assigned (by chance, like flipping a coin) to one of four treatment
 interventions. All four treatment interventions involve educating subjects about pain,
 discussing the impact of pain, and discussing different ways to manage it in hopes of
 decreasing subjects' pain and its impact on their lives. Two treatment interventions will
 also involve self-hypnosis. During self-hypnosis, subjects learn to enter a state of focused
 attention, and then change how they experience pain. All four treatment interventions are
 called "self-management" approaches to pain management. All of these treatments are commonly
 used in pain clinics and have been used to treat pain in persons with MS and SCI. We are
 interested in comparing the four different approaches to treating chronic pain.

 A research staff member will also contact each subject six 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 treatment, about halfway through the
 treatment period, after the completion of treatment, and 3-, 6- and 12-months 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, treatments for pain the subject has received, medications or drugs
 the subject has used, and any depressive symptoms the subject may have experienced.

 We will also ask each subject to participate in a brain activity assessment following the end
 of treatment. The brain activity will be done the same way as described earlier and will take
 place at the Integrated Brain Imaging Center at the University of Washington.
Inclusion Criteria:

 1. 18 years of age or older;

 2. diagnosis of SCI, MS, AMP, MD or LBP

 3. moderate to severe chronic pain possibly related to MS, SCI, AMP, MD, or LBP that is
 persistent in nature;

 4. able to read, speak, and understand English.

 Exclusion Criteria:

 1. severe cognitive impairment defined as two or more errors on the Six-Item Screen;

 2. psychiatric condition or symptoms that would interfere with participation;

 3. Pre-existing medical conditions that might interfere with EEG assessments.