MigraineNCT03799211
Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
A study testing Motivational Interviewing and Treatment as Usual in people with Migraine, run by NYU Langone Health at 1 site in United States.
Trial summary
Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Motivational Interviewing and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 1 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Migraine diagnosis age 16+
- English speaking
Who cannot join
- Unable to read the questionnaire, no phone number
Trial locations and contacts
1 site in 1 country.
About this study
Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients' reasons for making/not making the appointment.
- Conditions
- Migraine
- Being tested
- Motivational Interviewing, Treatment as Usual
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Phone call using motivational interviewing technique
Treatment as UsualBehavioural
will receive a regular study phone call after three months
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
| Usual Care | Active comparator | Not described Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Measured: 3-6 Months
Secondary outcomes (5)
Percentage of Participants Who Attended Appointments
Of those who initiated behavioral therapy, percentage who attended appointments
Measured: 3-6 Months
Percentage of Participants Who Initiated Appointments
Measured: Month 3-4 post-recruitment
Mean Reported Importance of Managing Migraine
Reported the importance to participants of managing migraine. Importance was rated on a scale from 0 to 10, where the higher the score, the higher the importance.
Measured: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Managing Migraines
Reported confidence in participant's ability to manage migraine. Confidence was rated on a scale from 0 to 10, with the higher the score, the higher the confidence.
Measured: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Behavioral Therapy
Reported confidence in behavioral therapy to help participant manage migraine. Confidence was rated on a scale from 0 to 10, where the higher the score, the higher the confidence.
Measured: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start4 Jun 2018
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mia Minen, MD, Principal investigator, NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03799211
- Sponsor's protocol ID
- 16-00937
- Status last verified
- Jul 2020
- First submitted
- 31 Dec 2018
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine
- ClinicalTrials.gov ID
- NCT03799211
- Acronym / sponsor ID
- 16-00937
- Conditions
- Migraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Posted 23 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Migraine patients are oftentimes referred for evidence based behavioral therapies to prevent migraine. Yet, at follow-up visits, they report not seeing the behavioral therapist. This is a pilot feasibility acceptability study to assess whether motivational interviewing (MI) can be implemented in the headache center setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients' reasons for making/not making the appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational Interviewing |
| Usual Care | Active comparator | Behavioral: Treatment as Usual |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Migraine diagnosis age 16+
- English speaking
Key exclusion criteria (1 listed)
- Unable to read the questionnaire, no phone number
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 |
|---|---|---|
| Motivational InterviewingPhone call using motivational interviewing technique | Behavioural | Motivational Interviewing |
| Treatment as Usualwill receive a regular study phone call after three months | Behavioural | Usual Care |
Primary outcome
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Time frame: 3-6 Months
5 secondary outcomes
Percentage of Participants Who Attended Appointments
Time frame: 3-6 Months
Percentage of Participants Who Initiated Appointments
Time frame: Month 3-4 post-recruitment
Mean Reported Importance of Managing Migraine
Time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Managing Migraines
Time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Mean Reported Confidence in Behavioral Therapy
Time frame: First Follow-up Call (1 month post baseline) conducted only for the Arm/Group "Motivational Interviewing" and Last Follow-up Call (3-4 months post baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mia Minen, MD principal investigator
NYU Langone
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Treatment as Usual in people with Migraine, run by NYU Langone Health 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 2 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 23 Jul 2020. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Patients Who Made an Appointment for Behavioral Therapy (time frame: 3-6 Months). 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 23 Jul 2020.