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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental |
| |
| Usual Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | Phone call using motivational interviewing technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Made an Appointment for Behavioral Therapy | 3-6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Attended Appointments | Of those who initiated behavioral therapy, percentage who attended appointments | 3-6 Months |
| Percentage of Participants Who Initiated Appointments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mia Minen, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Interviewing | Motivational Interviewing: Phone call using motivational interviewing technique |
| FG001 | Usual Care | Treatment as Usual: will receive a regular study phone call after three months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Interviewing | Motivational Interviewing: Phone call using motivational interviewing technique |
| BG001 | Usual Care | Treatment as Usual: will receive a regular study phone call after three months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Made an Appointment for Behavioral Therapy | Posted | Number | percentage of participants | 3-6 Months |
|
|
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Serious and other [non-serious] adverse events were not collected or assessed as part of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Interviewing | Motivational Interviewing: Phone call using motivational interviewing technique |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mia Minen, MD, MPH | NYU Langone Health | 212-263-7744 | Mia.Minen@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 23, 2019 | Jul 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| Treatment as Usual | Behavioral | will receive a regular study phone call after three months |
|
| 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. | 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. | 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. | 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Percentage of Participants Who Attended Appointments | Of those who initiated behavioral therapy, percentage who attended appointments | Posted | Number | percentage of participants | 3-6 Months |
|
|
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| Secondary | Percentage of Participants Who Initiated Appointments | Posted | Number | percentage of participants | Month 3-4 post-recruitment |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 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) |
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 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) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Usual Care | Treatment as Usual: will receive a regular study phone call after three months | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009422 | Nervous System Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |