Migraine
Conditions
Brief 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 setting to help improve initiation and adherence to behavioral therapy for migraine. We will also assess patients' reasons for making/not making the appointment.
Interventions
BEHAVIORALMotivational Interviewing
Phone call using motivational interviewing technique
BEHAVIORALTreatment as Usual
will receive a regular study phone call after three months
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Migraine diagnosis age 16+ * English speaking
Exclusion criteria
* Unable to read the questionnaire, no phone number
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Who Made an Appointment for Behavioral Therapy | 3-6 Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Attended Appointments | 3-6 Months | Of those who initiated behavioral therapy, percentage who attended appointments |
| Percentage of Participants Who Initiated Appointments | Month 3-4 post-recruitment | — |
| Mean Reported Importance of Managing Migraine | 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) | 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. |
| Mean Reported Confidence in Managing Migraines | 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) | 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. |
| Mean Reported Confidence in Behavioral Therapy | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Motivational Interviewing Motivational Interviewing: Phone call using motivational interviewing technique | 36 |
| Usual Care Treatment as Usual: will receive a regular study phone call after three months | 40 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 13 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Motivational Interviewing | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 40.4 years STANDARD_DEVIATION 12.3 | 39.3 years STANDARD_DEVIATION 12.2 | 38.1 years STANDARD_DEVIATION 12.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 66 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) White | 26 Participants | 59 Participants | 33 Participants |
| Region of Enrollment United States | 36 participants | 76 participants | 40 participants |
| Sex: Female, Male Female | 32 Participants | 71 Participants | 39 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Percentage of Patients Who Made an Appointment for Behavioral Therapy
Time frame: 3-6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motivational Interviewing | Percentage of Patients Who Made an Appointment for Behavioral Therapy | 37.5 percentage of participants |
| Usual Care | Percentage of Patients Who Made an Appointment for Behavioral Therapy | 22.2 percentage of participants |
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing | Mean Reported Confidence in Behavioral Therapy | First Follow-Up Call | NA score on a scale | — |
| Motivational Interviewing | Mean Reported Confidence in Behavioral Therapy | Last Follow-Up Call | 5.35 score on a scale | Standard Deviation 2.59 |
| Usual Care | Mean Reported Confidence in Behavioral Therapy | First Follow-Up Call | 4.83 score on a scale | Standard Deviation 2.47 |
| Usual Care | Mean Reported Confidence in Behavioral Therapy | Last Follow-Up Call | 5.04 score on a scale | Standard Deviation 1.95 |
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing | Mean Reported Confidence in Managing Migraines | First Follow-Up Call | NA score on a scale | — |
| Motivational Interviewing | Mean Reported Confidence in Managing Migraines | Last Follow-Up Call | 6.59 score on a scale | Standard Deviation 2.26 |
| Usual Care | Mean Reported Confidence in Managing Migraines | First Follow-Up Call | 6.26 score on a scale | Standard Deviation 2.27 |
| Usual Care | Mean Reported Confidence in Managing Migraines | Last Follow-Up Call | 6.62 score on a scale | Standard Deviation 2.5 |
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.
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Motivational Interviewing | Mean Reported Importance of Managing Migraine | First Follow-Up Call | NA units on a scale | — |
| Motivational Interviewing | Mean Reported Importance of Managing Migraine | Last Follow-Up Call | 9.19 units on a scale | Standard Deviation 1.3 |
| Usual Care | Mean Reported Importance of Managing Migraine | First Follow-Up Call | 9.16 units on a scale | Standard Deviation 1.27 |
| Usual Care | Mean Reported Importance of Managing Migraine | Last Follow-Up Call | 9.22 units on a scale | Standard Deviation 1.18 |
Secondary
Percentage of Participants Who Attended Appointments
Of those who initiated behavioral therapy, percentage who attended appointments
Time frame: 3-6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motivational Interviewing | Percentage of Participants Who Attended Appointments | 22.2 percentage of participants |
| Usual Care | Percentage of Participants Who Attended Appointments | 21.9 percentage of participants |
Secondary
Percentage of Participants Who Initiated Appointments
Time frame: Month 3-4 post-recruitment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Motivational Interviewing | Percentage of Participants Who Initiated Appointments | 40.7 percentage of participants |
| Usual Care | Percentage of Participants Who Initiated Appointments | 68.8 percentage of participants |