Multiple SclerosisENHANCENCT02474940
MS Symptom Management Study
A study testing Intervention #1, Intervention #2 and Intervention #3 in people with Multiple Sclerosis and Chronic Pain, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Chronic Pain, Fatigue
- What is being tested?
- Intervention #1, Intervention #2 and Intervention #3
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of MS
- Moderate to severe chronic pain and/or fatigue
- Able to read, speak, and understand English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington, Ninth and Jefferson Building
Seattle, Washington, 98104
About this study
Official title: Enhancing the Benefits of Pain and Fatigue Treatment in MS
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.
Read the detailed description
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:
- 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:
- 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;
- 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.
- Conditions
- Multiple Sclerosis, Chronic Pain, Fatigue
- Being tested
- Intervention #1, Intervention #2, Intervention #3
- 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
- Medical subject headings
- Multiple Sclerosis, Chronic Pain, Fatigue, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Central Nervous System Diseases, Demyelinating Autoimmune Diseases, CNS, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention #1Behavioural
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 #2Behavioural
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 #3Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention #1 | Experimental | NF-HYP Receives: Behavioral: Intervention #1 |
| Intervention #2 | Experimental | MM-HYP Receives: Behavioral: Intervention #2 |
| Intervention #3 | Experimental | HYP-ONLY Receives: Behavioral: Intervention #3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Mark Jensen, University of Washington
- Investigators
- Mark Jensen, Ph.D., Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474940
- Sponsor's protocol ID
- 46765-EB
- Other IDs
- RG 5232-A-4
- Acronym
- ENHANCE
- Status last verified
- Dec 2017
- First submitted
- 21 May 2015
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Benefits of Pain and Fatigue Treatment in MS
- ClinicalTrials.gov ID
- NCT02474940
- Acronym / sponsor ID
- ENHANCE / 46765-EB
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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:
- 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;
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention #1 | Experimental | Behavioral: Intervention #1NF-HYP |
| Intervention #2 | Experimental | Behavioral: Intervention #2MM-HYP |
| Intervention #3 | Experimental | Behavioral: Intervention #3HYP-ONLY |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Diagnosis of MS
- Moderate to severe chronic pain and/or fatigue
- Able to read, speak, and understand English
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention #1Intervention #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. | Behavioural | Intervention #1 |
| Intervention #2Intervention #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. | Behavioural | Intervention #2 |
| Intervention #3Intervention #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. | Behavioural | Intervention #3 |
Primary outcome
Change in average pain intensity pre-treatment to post-treatment
Time frame: 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
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.
Change in average fatigue severity pre-treatment to post-treatment
Time frame: 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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Jensen, Ph.D. principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention #1, Intervention #2 and Intervention #3 in people with Multiple Sclerosis and Chronic Pain, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in average pain intensity pre-treatment to post-treatment (time frame: 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2017.