Relapsing-remitting Multiple SclerosisMIMSNCT02010554
Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
A study testing Brief Education and Motivational Interviewing-Cognitive Behavioral Therapy in people with Relapsing-remitting Multiple Sclerosis, run by University of Missouri, Kansas City at 2 sites in United States.
Trial summary
Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- Brief Education and Motivational Interviewing-Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Sep 2015
- 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
- Diagnosis of relapsing remitting MS based on established guidelines
- Not taking recommended therapy
- Provider recommendation for DMT use
- At least 18 years of age
- Access to a telephone
- English speaking
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Missouri-Kansas City
Kansas City, Missouri, 64110
Kessler Rehabilitation Institute
West Orange, New Jersey, 07052
About this study
Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in initiating disease modifying medications than patients given brief education and treatment as usual.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- Brief Education, Motivational Interviewing-Cognitive Behavioral Therapy
- Keywords
- Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief EducationBehavioural
Give patients a pamphlet discussing pros and cons of disease modifying therapies
Motivational Interviewing-Cognitive Behavioral TherapyBehavioural
A telephone based talk therapy discussing pros and cons of medication use in MS.
| Study group | Role | What they receive |
|---|---|---|
| Brief Education | Active comparator | Patients receive a brief educational packet along with treatment as usual Receives: Behavioral: Brief Education |
| MI-CBT Treatment | Experimental | Patients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet. Receives: Behavioral: Brief Education; Behavioral: Motivational Interviewing-Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Treatment Survey
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Measured: 10 weeks after enrollment
Secondary outcomes (3)
Adherence Treatment Survey
Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.
Measured: 10 weeks after enrollment
Adherence Treatment Survey
Whether the patient reports that he/she plans to discuss disease modifying therapies with a care provider on a "yes"/"no" question.
Measured: 5 weeks after enrollment
Adherence Treatment Survey
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
Measured: 5 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri, Kansas City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jared Bruce, University of Missouri, Kansas City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010554
- Sponsor's protocol ID
- HC 0138-02
- Other IDs
- 0033769
- Acronym
- MIMS
- Status last verified
- Nov 2015
- First submitted
- 9 Dec 2013
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Talk Therapy Protocol to Help Patients Make Treatment Decisions in MS
- ClinicalTrials.gov ID
- NCT02010554
- Acronym / sponsor ID
- MIMS / HC 0138-02
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Disease modifying medication, Relapsing-Remitting MS, Motivational Interviewing, Telephone Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Missouri, Kansas CityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 12 Dec 2013 (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.
Between 15-20% of MS patients decide not to initiate disease modifying therapies after being diagnosed with MS. For this study, we will develop a telephone-based talk therapy intervention and then conduct a randomized controlled trial. Patients will be assigned to either 5 weekly 20 minute telephone sessions of psychotherapy or a brief education control condition. We hypothesize that patients undergoing phone therapy will be more likely to indicate they are interested in initiating disease modifying medications than patients given brief education and treatment as usual.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Education | Active comparator | Behavioral: Brief EducationPatients receive a brief educational packet along with treatment as usual |
| MI-CBT Treatment | Experimental | Behavioral: Brief Education, Behavioral: Motivational Interviewing-Cognitive Behavioral TherapyPatients receive five 20 minute phone sessions of motivational interviewing/cognitive behavioral therapy weekly along with a brief educational packet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of relapsing remitting MS based on established guidelines
- Not taking recommended therapy
- Provider recommendation for DMT use
- At least 18 years of age
- Access to a telephone
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Brief EducationGive patients a pamphlet discussing pros and cons of disease modifying therapies | Behavioural | Brief Education, MI-CBT Treatment |
| Motivational Interviewing-Cognitive Behavioral TherapyA telephone based talk therapy discussing pros and cons of medication use in MS. | Behavioural | MI-CBT Treatment |
Primary outcome
Adherence Treatment Survey
Time frame: 10 weeks after enrollment
Whether the patient indicates if he/she decided to re-initiate disease modifying therapies on a "yes"/"no" question.
3 secondary outcomes
Adherence Treatment Survey
Time frame: 10 weeks after enrollment
Adherence Treatment Survey
Time frame: 5 weeks after enrollment
Adherence Treatment Survey
Time frame: 5 weeks after enrollment
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 2 Dec 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Education and Motivational Interviewing-Cognitive Behavioral Therapy in people with Relapsing-remitting Multiple Sclerosis, run by University of Missouri, Kansas City at 2 sites 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 6 inclusion and 1 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 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adherence Treatment Survey (time frame: 10 weeks after enrollment). 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 2 Dec 2015.