Trial Outcomes & Findings for Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine (NCT NCT03799211)

NCT ID: NCT03799211

Last Updated: 2020-07-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: 3-6 Months
• Results posted on: 2020-07-23

Participant Flow

Participant milestones

Measure	Motivational Interviewing Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care Treatment as Usual: will receive a regular study phone call after three months
Overall Study STARTED	36	40
Overall Study COMPLETED	32	27
Overall Study NOT COMPLETED	4	13

Reasons for withdrawal

Measure	Motivational Interviewing Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care Treatment as Usual: will receive a regular study phone call after three months
Overall Study Lost to Follow-up	2	13
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Adherence to and Beliefs on Recommendations for Behavioral Treatment for Migraine

Baseline characteristics by cohort

Measure	Motivational Interviewing n=36 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=40 Participants Treatment as Usual: will receive a regular study phone call after three months	Total n=76 Participants Total of all reporting groups
Age, Continuous	40.4 years STANDARD_DEVIATION 12.3 • n=5 Participants	38.1 years STANDARD_DEVIATION 12.1 • n=7 Participants	39.3 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	39 Participants n=7 Participants	71 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants	40 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 3-6 Months

Outcome measures

Measure	Motivational Interviewing n=32 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=27 Participants Treatment as Usual: will receive a regular study phone call after three months
Percentage of Patients Who Made an Appointment for Behavioral Therapy	37.5 percentage of participants	22.2 percentage of participants

SECONDARY outcome

Timeframe: 3-6 Months

Of those who initiated behavioral therapy, percentage who attended appointments

Outcome measures

Measure	Motivational Interviewing n=27 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=32 Participants Treatment as Usual: will receive a regular study phone call after three months
Percentage of Participants Who Attended Appointments	22.2 percentage of participants	21.9 percentage of participants

SECONDARY outcome

Timeframe: Month 3-4 post-recruitment

Outcome measures

Measure	Motivational Interviewing n=27 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=32 Participants Treatment as Usual: will receive a regular study phone call after three months
Percentage of Participants Who Initiated Appointments	40.7 percentage of participants	68.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Motivational Interviewing n=27 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=32 Participants Treatment as Usual: will receive a regular study phone call after three months
Mean Reported Importance of Managing Migraine First Follow-Up Call	NA units on a scale Standard Deviation NA Only one follow-up call was conducted for this arm	9.16 units on a scale Standard Deviation 1.27
Mean Reported Importance of Managing Migraine Last Follow-Up Call	9.19 units on a scale Standard Deviation 1.3	9.22 units on a scale Standard Deviation 1.18

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Motivational Interviewing n=27 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=32 Participants Treatment as Usual: will receive a regular study phone call after three months
Mean Reported Confidence in Managing Migraines First Follow-Up Call	NA score on a scale Standard Deviation NA Only one follow-up call was conducted for this arm	6.26 score on a scale Standard Deviation 2.27
Mean Reported Confidence in Managing Migraines Last Follow-Up Call	6.59 score on a scale Standard Deviation 2.26	6.62 score on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Motivational Interviewing n=27 Participants Motivational Interviewing: Phone call using motivational interviewing technique	Usual Care n=32 Participants Treatment as Usual: will receive a regular study phone call after three months
Mean Reported Confidence in Behavioral Therapy First Follow-Up Call	NA score on a scale Standard Deviation NA Only one follow-up call was conducted for this arm	4.83 score on a scale Standard Deviation 2.47
Mean Reported Confidence in Behavioral Therapy Last Follow-Up Call	5.35 score on a scale Standard Deviation 2.59	5.04 score on a scale Standard Deviation 1.95

Adverse Events

Motivational Interviewing

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mia Minen, MD, MPH

NYU Langone Health

Phone: 212-263-7744

Email: Mia.Minen@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place